NCT00699998

Brief Summary

This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
9,326

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2008

Typical duration for phase_3

Geographic Reach
49 countries

664 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 7, 2013

Completed
Last Updated

May 7, 2013

Status Verified

March 1, 2013

Enrollment Period

3.8 years

First QC Date

June 16, 2008

Results QC Date

March 21, 2013

Last Update Submit

March 21, 2013

Conditions

Keywords

ACS

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke

    The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.

    Randomization through end of study (30-month visit)

Secondary Outcomes (9)

  • Percentage of Participants With a Composite Endpoint of CV Death and MI

    Randomization through end of study (30-month visit)

  • Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA)

    Randomization through end of study (30-month visit)

  • Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke

    Randomization through end of study (30-month visit)

  • Platelet Aggregation Measures

    Day 30 and 12 Months

  • Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP)

    Day 30 and 6 Months

  • +4 more secondary outcomes

Study Arms (2)

Prasugrel

EXPERIMENTAL

Prasugrel and Low-dose Commercially-available Aspirin

Drug: PrasugrelDrug: Commercially-available Aspirin

Clopidogrel

ACTIVE COMPARATOR

Clopidogrel and Low-Dose Commercially-available Aspirin

Drug: ClopidogrelDrug: Commercially-available Aspirin

Interventions

300 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study

Clopidogrel

30 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study

Also known as: LY640315, Effient, Efient, CS-747
Prasugrel

Low-dose aspirin, oral, as prescribed by physician through end of study

ClopidogrelPrasugrel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have had a Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) index event within 10 days prior to randomization
  • Had a medical management strategy decision made with reasonable certainty that neither percutaneous coronary intervention (PCI) nor coronary artery bypass graft (CABG) is planned for treatment of the index event
  • Had at least 1 of 4 specified high-risk features at the time of the UA/NSTEMI event

You may not qualify if:

  • Decision for medical management greater than 72 hours after onset of index event without commercial clopidogrel treatment within 72 hours following onset of the index event.
  • Insignificant coronary artery disease (CAD) on coronary angiography if performed for Index Event (absence of greater than or equal to 30% stenosis in at least one native vessel)
  • Previous or planned PCI or CABG as treatment for the index event
  • PCI/CABG within previous 30 days
  • ST-segment elevation myocardial infarction (STEMI) as the index event
  • Cardiogenic shock, Refractory ventricular arrhythmias, New York Heart Association (NYHA) Class IV congestive heart failure (CHF) within the previous 24 hours
  • History of ischemic or hemorrhagic stroke, transient ischemic attack (TIA), Intracranial neoplasm, arteriovenous malformation, or aneurysm
  • History of spontaneous gastrointestinal (GI) or non-GI bleeding requiring hospitalization for treatment, unless definitive treatment has occurred and there is low likelihood of recurrence
  • Hemodialysis or peritoneal dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (688)

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Birmingham, Alabama, 35233, United States

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Huntsville, Alabama, 35801, United States

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Glendale, Arizona, 85306, United States

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Tucson, Arizona, 85724, United States

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Fort Smith, Arkansas, 72917, United States

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Anaheim, California, 92801, United States

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Banning, California, 92220, United States

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Bellflower, California, 90706, United States

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Healdsburg, California, 95448, United States

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Lancaster, California, 93534, United States

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Long Beach, California, 90822, United States

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Los Angeles, California, 90027, United States

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Mather, California, 95655, United States

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Newport Beach, California, 92663, United States

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Palo Alto, California, 94304, United States

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Sacramento, California, 95817, United States

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San Diego, California, 92123, United States

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Sylmar, California, 91342, United States

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Yuba City, California, 95991, United States

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Colorado Springs, Colorado, 80909, United States

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Denver, Colorado, 80218, United States

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Loveland, Colorado, 80538, United States

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Wheat Ridge, Colorado, 80033, United States

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Washington D.C., District of Columbia, 20422, United States

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Atlantis, Florida, 33462, United States

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Aventura, Florida, 33180, United States

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Boynton Beach, Florida, 33472, United States

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Brandon, Florida, 33511, United States

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Deerfield Beach, Florida, 33442, United States

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Hudson, Florida, 34667, United States

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Lakeland, Florida, 33805, United States

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Melbourne, Florida, 32901, United States

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Miami, Florida, 33176, United States

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Orlando, Florida, 32803, United States

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Ormond Beach, Florida, 32174, United States

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Panama City, Florida, 32401, United States

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Pensacola, Florida, 32501, United States

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Port Charlotte, Florida, 33952, United States

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Sarasota, Florida, 34232, United States

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Tallahassee, Florida, 32308, United States

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Tampa, Florida, 33613, United States

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Trinity, Florida, 34655, United States

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West Palm Beach, Florida, 33401, United States

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Atlanta, Georgia, 30342, United States

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Covington, Georgia, 30014, United States

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Decatur, Georgia, 30033, United States

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Riverdale, Georgia, 30274, United States

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Savannah, Georgia, 31405, United States

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Melrose Park, Illinois, 60160, United States

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Peoria, Illinois, 61614, United States

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Rock Island, Illinois, 61201, United States

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Anderson, Indiana, 46011, United States

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Elkhart, Indiana, 46514, United States

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Hammond, Indiana, 46320, United States

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Indianapolis, Indiana, 46250, United States

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Muncie, Indiana, 47303, United States

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Valparaiso, Indiana, 46383, United States

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Ames, Iowa, 50010, United States

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Louisville, Kentucky, 40207, United States

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Alexandria, Louisiana, 71301, United States

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Baton Rouge, Louisiana, 70808, United States

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Covington, Louisiana, 70433, United States

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Lake Charles, Louisiana, 70601, United States

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Natchitoches, Louisiana, 71457, United States

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New Orleans, Louisiana, 70112, United States

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Baltimore, Maryland, 21287, United States

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Salisbury, Maryland, 21804, United States

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Boston, Massachusetts, 02135, United States

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Fall River, Massachusetts, 02720, United States

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Bay City, Michigan, 48706, United States

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Flint, Michigan, 48532, United States

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Minneapolis, Minnesota, 55417, United States

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Picayune, Mississippi, 39466, United States

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Columbia, Missouri, 65201, United States

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Kansas City, Missouri, 64111, United States

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St Louis, Missouri, 63128, United States

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Kalispell, Montana, 59901, United States

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Omaha, Nebraska, 68198, United States

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Las Vegas, Nevada, 89148, United States

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Lenoir, North Carolina, 28645, United States

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Bahía Blanca, B8001DDU, Argentina

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Buenos Aires, 1094, Argentina

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Caba, C1180AAX, Argentina

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Concordia, E3202BQF, Argentina

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Corrientes, 3400, Argentina

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Córdoba, X5000JHQ, Argentina

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Formosa, 3606, Argentina

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Godoy Cruz, 5501, Argentina

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Mar del Plata, B7600FZD, Argentina

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Morón, B1708KCH, Argentina

Location

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Rosario, S2002KDS, Argentina

Location

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Salta, A4402DTC, Argentina

Location

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San Luis, D5702JRS, Argentina

Location

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San Miguel de Tucumán, T4000NIL, Argentina

Location

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Santa Fe, S3000FUJ, Argentina

Location

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Villa Cabrera, S5009BSN, Argentina

Location

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Villa María, X5900JKA, Argentina

Location

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Coffs Harbour, New South Wales, 2450, Australia

Location

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Lismore, New South Wales, 2480, Australia

Location

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Newcastle, New South Wales, 2305, Australia

Location

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Wollongong, New South Wales, 2500, Australia

Location

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Herston, Queensland, 4029, Australia

Location

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Nambour, Queensland, 4560, Australia

Location

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Redcliffe, Queensland, 4020, Australia

Location

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Southport, Queensland, 4215, Australia

Location

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Bedford Park, South Australia, 5042, Australia

Location

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Elizabeth Vale, South Australia, 5112, Australia

Location

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Hobart, Tasmania, 7000, Australia

Location

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Feldkirch, 6807, Austria

Location

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Vienna, 1100, Austria

Location

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Brussels, 1200, Belgium

Location

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Huy, 4500, Belgium

Location

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Liège, 4000, Belgium

Location

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Mol, 2400, Belgium

Location

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Overpelt, 3900, Belgium

Location

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Aracaju, 49015-400, Brazil

Location

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Belo Horizonte, 30380-090, Brazil

Location

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Blumenau, 89010-500, Brazil

Location

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Brasília, 70658-700, Brazil

Location

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Campina Grande do Sul, 83430-000, Brazil

Location

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Campinas, 13010-001, Brazil

Location

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Campo Grande, 79080-190, Brazil

Location

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Caxias do Sul, 95070560, Brazil

Location

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Curitiba, 80010-030, Brazil

Location

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Dois Lajeados, 95900-000, Brazil

Location

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Goiânia, 74223-130, Brazil

Location

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Maceió, 57021-500, Brazil

Location

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Maringá, 87015-290, Brazil

Location

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Passo Fundo, 99010-080, Brazil

Location

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Piracicaba, 13405-126, Brazil

Location

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Porto Alegre, 91350-200, Brazil

Location

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Recife, 52051-380, Brazil

Location

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Ribeirão Preto, 14048-900, Brazil

Location

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Rio de Janeiro, 21041-030, Brazil

Location

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Salvador, 41144900, Brazil

Location

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Santo André, 09190-610, Brazil

Location

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Sao Jose Rio Preto, 15090-000, Brazil

Location

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São Caetano do Sul, 09540-400, Brazil

Location

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São José, 88103-460, Brazil

Location

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São Paulo, 05017000, Brazil

Location

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Uberlândia, 38400-368, Brazil

Location

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Votuporanga, 15500-003, Brazil

Location

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Dimitrovgrad, 6400, Bulgaria

Location

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Haskovo, 6300, Bulgaria

Location

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Kazanlak, 6100, Bulgaria

Location

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Kyustendil, 2500, Bulgaria

Location

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Pazardzhik, 4400, Bulgaria

Location

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Pleven, 5800, Bulgaria

Location

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Plovdiv, 4002, Bulgaria

Location

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Rousse, 7002, Bulgaria

Location

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Sofia, 1606, Bulgaria

Location

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Varna, 9010, Bulgaria

Location

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Edmonton, Alberta, T6K 4C1, Canada

Location

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Campbell River, British Columbia, V9W 5Y4, Canada

Location

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St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

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Halifax, Nova Scotia, B3H 3A7, Canada

Location

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Ajax, Ontario, L1S 2J5, Canada

Location

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Burlington, Ontario, L7M 4Y1, Canada

Location

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Cambridge, Ontario, N1R 7R1, Canada

Location

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Greater Sudbury, Ontario, P3E 2N8, Canada

Location

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London, Ontario, N6A 5A5, Canada

Location

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Oshawa, Ontario, L1H 1B9, Canada

Location

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Sarnia, Ontario, N7T 4R9, Canada

Location

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Scarborough Village, Ontario, M1E 5E9, Canada

Location

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Montreal, Quebec, H3G 1A4, Canada

Location

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Sainte-Foy, Quebec, G1V 4G5, Canada

Location

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La Serena, Chile

Location

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Osorno, 5290000, Chile

Location

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Puente Alto, 8207257, Chile

Location

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Rancagua, Chile

Location

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Santiago, 8900085, Chile

Location

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Temuco, 478-1151, Chile

Location

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Viña del Mar, Chile

Location

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Beijing, 100032, China

Location

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Beijing, 100730, China

Location

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Changsha, 410013, China

Location

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Fuzhou, 350001, China

Location

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Guangzhou, 510120, China

Location

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Hangzhou, 310013, China

Location

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Harbin, 150001, China

Location

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Jiangsu, 210009, China

Location

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Nanchang, China

Location

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Nanjing, 210008, China

Location

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Shanghai, 200032, China

Location

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Shaoguan, 512026, China

Location

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Shengyang, 110004, China

Location

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Shenyang, 110001, China

Location

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Shijiazhuang, 050050, China

Location

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Suzhou, 215004, China

Location

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Wenzhou, 325027, China

Location

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Wuhan, 430030, China

Location

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Wuhan, 430060, China

Location

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Xi'an, 710061, China

Location

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Xuzhou, 221006, China

Location

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Zhengzhou, 450003, China

Location

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Armenia-Quindio, Colombia

Location

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Barranquilla, Colombia

Location

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Bogotá, Colombia

Location

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Cali, Colombia

Location

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Floridablanca, Colombia

Location

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Medellín, Colombia

Location

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San José, Costa Rica

Location

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Dubrovnik, 20000, Croatia

Location

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Karlovac, 47000, Croatia

Location

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Koprivnica, 48000, Croatia

Location

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Krapinske Toplice, 49217, Croatia

Location

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Rijeka, 51 000, Croatia

Location

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Slavonski Brod, 35 000, Croatia

Location

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Split, 21000, Croatia

Location

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Varaždin, 42 000, Croatia

Location

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Zadar, 23000, Croatia

Location

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Zagreb, 10000, Croatia

Location

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Děčín, 405 99, Czechia

Location

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Frýdek-Místek, 738 18, Czechia

Location

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Hradec Králové, 500 05, Czechia

Location

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Karlovy Vary, 360 66, Czechia

Location

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Kroměříž, 767 55, Czechia

Location

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Liberec, 460 03, Czechia

Location

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Nový Jičín, 74101, Czechia

Location

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Pardubice, 532 03, Czechia

Location

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Prague, 140 21, Czechia

Location

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Zlín, 76275, Czechia

Location

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Copenhagen, 2300, Denmark

Location

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Copenhagen, 2400, Denmark

Location

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Hellerup, 2900, Denmark

Location

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Alexandria, 21131, Egypt

Location

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Beni Sweif, Egypt

Location

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Cairo, Egypt

Location

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Ismailia, Egypt

Location

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Menoufiya, Egypt

Location

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Jyväskylä, 40620, Finland

Location

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Angers, 49933, France

Location

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Arras, 62000, France

Location

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Besançon, 25030, France

Location

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Cambrai, 59407, France

Location

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Chartres, 28018, France

Location

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Dijon, 21079, France

Location

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Douai, 59507, France

Location

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La Roche-sur-Yon, 85025, France

Location

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Lagny-sur-Marne, 77405, France

Location

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Nantes, 44277, France

Location

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Nice, 06002, France

Location

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Paris, 75015, France

Location

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Pessac, 33604, France

Location

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Poitiers, 86021, France

Location

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Strasbourg, 67091, France

Location

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Toulouse, 31059, France

Location

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Valenciennes, 59322, France

Location

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Vandœuvre-lès-Nancy, 54511, France

Location

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Bad Nauheim, 61231, Germany

Location

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Cologne, 50968, Germany

Location

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Darmstadt, 64283, Germany

Location

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Dortmund, 44137, Germany

Location

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Frankfurt, 65929, Germany

Location

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Halle, 06120, Germany

Location

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Idar-Oberstein, 55743, Germany

Location

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Leipzig, 04289, Germany

Location

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Mainz, 55131, Germany

Location

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Mannheim, 68167, Germany

Location

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Stuttgart, 70376, Germany

Location

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Tübingen, 72076, Germany

Location

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Athens, 16673, Greece

Location

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Haidari/Athens, 12462, Greece

Location

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Kallithea, 17674, Greece

Location

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Magoula, 19600, Greece

Location

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Pátrai, 26504, Greece

Location

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Rhodes, 85100, Greece

Location

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Trikala, 42100, Greece

Location

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Baja, 6500, Hungary

Location

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Békéscsaba, 5601, Hungary

Location

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Budapest, 1125, Hungary

Location

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Kalocsa, 6300, Hungary

Location

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Kecskemét, 6000, Hungary

Location

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Komárom, 2921, Hungary

Location

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Miskolc, H-3529, Hungary

Location

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Sátoraljaújhely, H-3980, Hungary

Location

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Sopron, 9400, Hungary

Location

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Szekszárd, 7100, Hungary

Location

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Zalaegerszeg, 8900, Hungary

Location

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Ahmedabad, 382 428, India

Location

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Anand, 388325, India

Location

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Aurangabad, 431001, India

Location

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Bangalore, 560034, India

Location

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Bārāmati, 413102, India

Location

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Bikaner, 334003, India

Location

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Calicut, 673004, India

Location

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Chidambaram, 608002, India

Location

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Coimbatore, 641004, India

Location

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Ernākulam, 683577, India

Location

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Guntur, 522001, India

Location

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Gūrgaon, 122001, India

Location

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Hyderabaad, 500001, India

Location

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Indore, 452018, India

Location

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Jaipur, 302017, India

Location

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Jalandhar, 144008, India

Location

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Kochi, 683572, India

Location

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Kolkata, 700091, India

Location

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Kottayam, 686016, India

Location

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Lucknow, 226003, India

Location

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Madurai, 625020, India

Location

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Mumbai, 400012, India

Location

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Mysore, 570004, India

Location

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Nagpur, 440033, India

Location

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Nashik, 422005, India

Location

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New Delhi, 110015, India

Location

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Patiāla, 147001, India

Location

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Pune, 411033, India

Location

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Saket, 110017, India

Location

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Secunderabad, 500 003, India

Location

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Shivamogga, 577201, India

Location

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Solapur, 413003, India

Location

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Surat, 395007, India

Location

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Thrissur, 680002, India

Location

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Tirupati, 517 507, India

Location

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Trivandrum, 695002, India

Location

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Vadodara, 390015, India

Location

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Vijayawada, 520008, India

Location

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Visakhapatnam, 530 003, India

Location

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Dublin, Ireland

Location

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Galway, Ireland

Location

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Afula, 18101, Israel

Location

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Ashkelon, 78278, Israel

Location

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Beersheba, 84101, Israel

Location

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Eilat, 88104, Israel

Location

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Haifa, 31096, Israel

Location

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Jerusalem, 91240, Israel

Location

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Kfar Saba, 44281, Israel

Location

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Nahariya, 22100, Israel

Location

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Nazareth, 16100, Israel

Location

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Rehovot, 76100, Israel

Location

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Tel Aviv, 64239, Israel

Location

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Tel Litwinsky, 52621, Israel

Location

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Tiberias, 15208, Israel

Location

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Tzfat, 13100, Israel

Location

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Albano Laziale, 00041, Italy

Location

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Ascoli Piceno, 63100, Italy

Location

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Bari, 70124, Italy

Location

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Bergamo, 24128, Italy

Location

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Brescia, 25127, Italy

Location

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Caserta, 81100, Italy

Location

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Forlì, 47100, Italy

Location

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Lecco, 23900, Italy

Location

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Legnago, 37045, Italy

Location

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Legnano, 20025, Italy

Location

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Milan, 20162, Italy

Location

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Novara, 28100, Italy

Location

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Parma, 43100, Italy

Location

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Perugia, 06156, Italy

Location

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Pescara, 65124, Italy

Location

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Reggio Emilia, 42100, Italy

Location

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Rimini, 47900, Italy

Location

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Rome, 00161, Italy

Location

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San Daniele del Friuli, 33038, Italy

Location

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Santa Maria Capua Vetere, 81055, Italy

Location

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Saronno, 21047, Italy

Location

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Sorrento, 80067, Italy

Location

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Terni, 5100, Italy

Location

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Trieste, 34142, Italy

Location

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Kaunas, LT-50009, Lithuania

Location

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Klaipėda, 92288, Lithuania

Location

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Šiauliai, 73231, Lithuania

Location

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Vilnius, LT-08661, Lithuania

Location

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Cheras, Kuala Lumpur, 56000, Malaysia

Location

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Johor Bahru, 80100, Malaysia

Location

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Kelantan, 16150, Malaysia

Location

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Kuala Lumpur, 59100, Malaysia

Location

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Kuala Selangor, 43300, Malaysia

Location

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Kuantan Pahang, 25100, Malaysia

Location

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Perak, 30990, Malaysia

Location

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Sarawak, 93586, Malaysia

Location

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Taiping Perak, 34000, Malaysia

Location

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Gozo, VCT102, Malta

Location

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Msida, 2090, Malta

Location

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Aguascalientes, 20230, Mexico

Location

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Culiacán, 80270, Mexico

Location

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Durango, 340000, Mexico

Location

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Jalisco, 44210, Mexico

Location

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León, 37660, Mexico

Location

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Monterrey, 64020, Mexico

Location

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Puebla City, 72490, Mexico

Location

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Querétaro, 76180, Mexico

Location

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San Luis Potosí City, 78240, Mexico

Location

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Tijuana, 22500, Mexico

Location

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Alkmaar, 1815 JD, Netherlands

Location

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Almelo, 7609 PP, Netherlands

Location

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Amsterdam, 1091AC, Netherlands

Location

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Apeldoorn, 7334 DZ, Netherlands

Location

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Beverwijk, 1942 LE, Netherlands

Location

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Blaricum, 1261 AN, Netherlands

Location

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Delft, 2625AD, Netherlands

Location

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Ede, 6716 RP, Netherlands

Location

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Eindhoven, 5623 EJ, Netherlands

Location

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Gouda, 2803 HH, Netherlands

Location

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Hoorn, 1625 HV, Netherlands

Location

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Leeuwarden, 8934 AD, Netherlands

Location

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Leiden, 2334 CK, Netherlands

Location

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Leiderdorp, 2353 GA, Netherlands

Location

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Meppel, 7943 KA, Netherlands

Location

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Oss, 5342 BT, Netherlands

Location

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Roosendaal, 4708 AE, Netherlands

Location

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Venlo, 5912 BL, Netherlands

Location

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Auckland, 0622, New Zealand

Location

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Christchurch, 8011, New Zealand

Location

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Nelson, 7010, New Zealand

Location

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Wellington, 6022, New Zealand

Location

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Coclé, Panama

Location

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David, Panama

Location

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Panama City, Panama

Location

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Arequipa, Peru

Location

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Callao, Peru

Location

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Cuzco, Peru

Location

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Lima, Lima 29, Peru

Location

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Cagayan de de Oro, 9000, Philippines

Location

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Cavite City, 4114, Philippines

Location

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Davao City, 8000, Philippines

Location

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Iloilo City, 5000, Philippines

Location

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Manila, 1000, Philippines

Location

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Marikina City, Philippines

Location

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Metro Manila, 1503, Philippines

Location

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Pasig, 1605, Philippines

Location

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Quezon City, 1102, Philippines

Location

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Quezon City, 1110, Philippines

Location

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Bydgoszcz, 85-826, Poland

Location

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Elblag, 02-300, Poland

Location

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Gdansk, 80-345, Poland

Location

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Katowice, 40-635, Poland

Location

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Koszalin, 75-581, Poland

Location

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Krakow, 31-501, Poland

Location

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Kutno, 99-300, Poland

Location

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Lodz, 94-255, Poland

Location

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Lubin, 59-301, Poland

Location

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Lublin, 20-954, Poland

Location

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Myślenice, 32-400, Poland

Location

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Nowy Sącz, 33-300, Poland

Location

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Oława, 55-200, Poland

Location

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Piotrkow Trybunalski, 97-300, Poland

Location

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Puławy, 24-100, Poland

Location

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Ruda Śląska, 41-703, Poland

Location

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Skierniewice, 96-100, Poland

Location

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Szczecin, 71-531, Poland

Location

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Warsaw, 04-439, Poland

Location

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Wałbrzych, 58-309, Poland

Location

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Wejherowo, 84-200, Poland

Location

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Wroclaw, 51-124, Poland

Location

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Aveiro, 3814-501, Portugal

Location

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Carnaxide, 2790-134, Portugal

Location

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Coimbra, 3000-075, Portugal

Location

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Leiria, 2410-197, Portugal

Location

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Ponta Delgada, 9500-370, Portugal

Location

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Santarém, 2005-177, Portugal

Location

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Setúbal, 2910-446, Portugal

Location

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Vila Franca de Xira, 5000-508, Portugal

Location

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Caguas, 00725, Puerto Rico

Location

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Mayagüez, 00680, Puerto Rico

Location

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San Juan, 00921-3201, Puerto Rico

Location

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Bacau, 600114, Romania

Location

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Baia Mare, 430110, Romania

Location

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Brasov, 500326, Romania

Location

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Brăila, 810249, Romania

Location

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Bucharest, Romania

Location

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Buzău, 120144, Romania

Location

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Cluj-Napoca, 400006, Romania

Location

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Focşani, 620034, Romania

Location

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Piteşti, 110084, Romania

Location

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Suceava, 7202237, Romania

Location

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Târgovişte, 130083, Romania

Location

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Arkhangelsk, 163045, Russia

Location

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Gatchina, 188300, Russia

Location

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Kazan', 420029, Russia

Location

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Kemerovo, 650002, Russia

Location

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Krasnoyarsk, 660062, Russia

Location

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Moscow, 127644, Russia

Location

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Nizhny Novgorod, 603005, Russia

Location

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Novokuznetsk, 654057, Russia

Location

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Novosibirsk, 630090, Russia

Location

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Omsk, 644018, Russia

Location

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Rostov-on-Don, 344068, Russia

Location

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Saint Petersburg, 197110, Russia

Location

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Saratov, 410028, Russia

Location

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Tomsk, 634012, Russia

Location

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Tyumen, 625000, Russia

Location

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Belgrade, 11040, Serbia

Location

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Kragujevac, 34000, Serbia

Location

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Niš, 18000, Serbia

Location

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Niška Banja, 18205, Serbia

Location

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Zemun, 11080, Serbia

Location

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Singapore, 119074, Singapore

Location

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Bratislava, 83348, Slovakia

Location

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Levice, 934 01, Slovakia

Location

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Martin, 03601, Slovakia

Location

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Nitra, 95001, Slovakia

Location

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Nové Zámky, 94034, Slovakia

Location

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Prešov, 08181, Slovakia

Location

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Ružomberok, 03426, Slovakia

Location

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Žilina, 010 01, Slovakia

Location

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Alberton, 1449, South Africa

Location

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Bloemfontein, 9301, South Africa

Location

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Cape Town, 7405, South Africa

Location

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Durban, 4071, South Africa

Location

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George, 6529, South Africa

Location

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Johannesburg, 2193, South Africa

Location

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Parktown West, 2193, South Africa

Location

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Somerset West, 7129, South Africa

Location

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Worcester, 6850, South Africa

Location

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Busan, 614-735, South Korea

Location

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Daegu, 705-718, South Korea

Location

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Daejeon, 302-718, South Korea

Location

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Gangwon-Do, 220-701, South Korea

Location

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Gwangju, 501-757, South Korea

Location

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Incheon, 405-760, South Korea

Location

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Jeonju, 561-712, South Korea

Location

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Jinju, 660-702, South Korea

Location

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Seoul, 120-752, South Korea

Location

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Ulsan, 682-714, South Korea

Location

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Barcelona, 08227, Spain

Location

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Girona, 17600, Spain

Location

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Málaga, 29010, Spain

Location

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Palma de Mallorca, 07198, Spain

Location

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Reus, 43201, Spain

Location

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San Boi de Llobregat, 08830, Spain

Location

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Seville, 41008, Spain

Location

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Valencia, 46014, Spain

Location

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Bollnäs, 82181, Sweden

Location

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Karlstad, 65185, Sweden

Location

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Lund, 22241, Sweden

Location

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Bellinzona, CH-6500, Switzerland

Location

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Winterthur, 8401, Switzerland

Location

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Kaohsiung City, 80756, Taiwan

Location

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Taipei, 220, Taiwan

Location

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Bangkok, 10700, Thailand

Location

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Chiang Mai, 50200, Thailand

Location

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Khon Kaen, 40002, Thailand

Location

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Nakhon Ratchasima, 30000, Thailand

Location

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Pathum Thani, 12120, Thailand

Location

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Udon Thani, 41000, Thailand

Location

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La Marsa, 2046, Tunisia

Location

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Menzel Bourguiba, 7050, Tunisia

Location

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Monastir, 5000, Tunisia

Location

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Sfax, 3051, Tunisia

Location

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Sousse, 4054, Tunisia

Location

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Tunis, 2070, Tunisia

Location

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Tunis Monfleury, 1008, Tunisia

Location

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Adana, 1330, Turkey (Türkiye)

Location

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Ankara, 06800, Turkey (Türkiye)

Location

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Bolu, 14280, Turkey (Türkiye)

Location

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Bursa, 16059, Turkey (Türkiye)

Location

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Edirne, 22030, Turkey (Türkiye)

Location

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Erzurum, 25050, Turkey (Türkiye)

Location

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Isparta, 32100, Turkey (Türkiye)

Location

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Istanbul, 34300, Turkey (Türkiye)

Location

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Kocaeli, 41380, Turkey (Türkiye)

Location

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Konya, 42075, Turkey (Türkiye)

Location

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Kırıkkale, 71100, Turkey (Türkiye)

Location

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Samsun, 55139, Turkey (Türkiye)

Location

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Trabzon, 61080, Turkey (Türkiye)

Location

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Cherkasy, 18009, Ukraine

Location

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Dnipropetrovsk, 49006, Ukraine

Location

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Donetsk, 83114, Ukraine

Location

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Ivano-Frankivsk, 76018, Ukraine

Location

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Kharkiv, 61176, Ukraine

Location

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Kiev, 02660, Ukraine

Location

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Kryvyy Rig, 50031, Ukraine

Location

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Kyiv, 3115, Ukraine

Location

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Luhansk, 91045, Ukraine

Location

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Lutsk, 43024, Ukraine

Location

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Lviv, 79015, Ukraine

Location

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Mykolayiv, 54003, Ukraine

Location

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Odesa, 65025, Ukraine

Location

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Poltava, 36038, Ukraine

Location

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Simferopol, 95026, Ukraine

Location

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Vinnytsia, 21029, Ukraine

Location

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Zaporizhzhya, 69000, Ukraine

Location

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Stockton-on-Tees, Cleveland, TS19 8PE, United Kingdom

Location

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Torquay, Cnwll, TQ2 7AA, United Kingdom

Location

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Durham, County Durham, DH1 5TW, United Kingdom

Location

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Chesterfield, Derbyshire, S44 5BL, United Kingdom

Location

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Plymouth, Devon, PL6 8DH, United Kingdom

Location

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Brighton, East Sussex, BN2 5BE, United Kingdom

Location

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Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Location

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Colchester, Essex, C04 5JL, United Kingdom

Location

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Romford, Essex, RM7 0AG, United Kingdom

Location

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London, Greater London, SE13 6LH, United Kingdom

Location

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Southall, Greater London, UB1 3HW, United Kingdom

Location

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Newport, Gwent, NP20 2UB, United Kingdom

Location

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Portsmouth, Hampshire, P06 3LY, United Kingdom

Location

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Orpington, Kent, BR6 8ND, United Kingdom

Location

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Lincoln, Lincolnshire, LN2 5QY, United Kingdom

Location

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Metropolitan Borough of Wirral, Merseyside, CH49 5PE, United Kingdom

Location

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York, North Yorkshire, YO31 8HE, United Kingdom

Location

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Nottingham, Nottinghamshire, NG5 1PD, United Kingdom

Location

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Yeovil, Somerset, BA21 4AT, United Kingdom

Location

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Sunderland, Sunderland, SR4 7TP, United Kingdom

Location

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Dundee, Tays, DD1 9SY, United Kingdom

Location

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Nuneaton, Warwickshire, CV10 7BL, United Kingdom

Location

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Warwick, Warwickshire, CV34 5BW, United Kingdom

Location

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Livingston, West Lothian, EH54 6PP, United Kingdom

Location

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Birmingham, West Midlands, B75 7RR, United Kingdom

Location

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Dudley, West Midlands, DY1 2HQ, United Kingdom

Location

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West Bromwich, West Midlands, B71 4HJ, United Kingdom

Location

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Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

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Bradford, West Yorkshire, BD9 6RJ, United Kingdom

Location

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Northampton, NN1 5BD, United Kingdom

Location

Related Publications (24)

  • Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

  • Marquis-Gravel G, Neely ML, Valgimigli M, Costa F, Van Klaveren D, Altner R, Bhatt DL, Armstrong PW, Fox KAA, White HD, Ohman EM, Roe MT. Long-Term Bleeding Risk Prediction with Dual Antiplatelet Therapy After Acute Coronary Syndromes Treated Without Revascularization. Circ Cardiovasc Qual Outcomes. 2020 Sep;13(9):e006582. doi: 10.1161/CIRCOUTCOMES.120.006582. Epub 2020 Aug 31.

  • Kaul P, Alexander KP, Ohman EM, Savu A, Roe MT, Goodman SG, Fox KA, White HD, Prabhakaran D, Hochman JS, Clemmensen P, Armstrong PW. Sex And Prognostic Significance of Self-Reported Frailty in Non-ST-Segment Elevation Acute Coronary Syndromes: Insights From the TRILOGY ACS Trial. Can J Cardiol. 2019 Apr;35(4):430-437. doi: 10.1016/j.cjca.2018.12.035. Epub 2018 Dec 31.

  • Fanaroff AC, Cyr D, Neely ML, Bakal J, White HD, Fox KAA, Armstrong PW, Lopes RD, Ohman EM, Roe MT. Days Alive and Out of Hospital: Exploring a Patient-Centered, Pragmatic Outcome in a Clinical Trial of Patients With Acute Coronary Syndromes. Circ Cardiovasc Qual Outcomes. 2018 Dec;11(12):e004755. doi: 10.1161/CIRCOUTCOMES.118.004755.

  • Inohara T, Pieper K, Wojdyla DM, Patel MR, Jones WS, Tricoci P, Mahaffey KW, James SK, Alexander JH, Lopes RD, Wallentin L, Ohman EM, Roe MT, Vemulapalli S. Incidence, timing, and type of first and recurrent ischemic events in patients with and without peripheral artery disease after an acute coronary syndrome. Am Heart J. 2018 Jul;201:25-32. doi: 10.1016/j.ahj.2018.03.013. Epub 2018 Mar 28.

  • Chan MY, Neely ML, Roe MT, Goodman SG, Erlinge D, Cornel JH, Winters KJ, Jakubowski JA, Zhou C, Fox KAA, Armstrong PW, White HD, Prabhakaran D, Ohman EM, Huber K; TRILOGY ACS Investigators. Temporal Biomarker Profiling Reveals Longitudinal Changes in Risk of Death or Myocardial Infarction in Non-ST-Segment Elevation Acute Coronary Syndrome. Clin Chem. 2017 Jul;63(7):1214-1226. doi: 10.1373/clinchem.2016.265272. Epub 2017 May 17.

  • Goldstein SA, Newby LK, Cyr DD, Neely M, Luscher TF, Brown EB, White HD, Ohman EM, Roe MT, Hamm CW. Relationship Between Peak Troponin Values and Long-Term Ischemic Events Among Medically Managed Patients With Acute Coronary Syndromes. J Am Heart Assoc. 2017 Apr 11;6(4):e005334. doi: 10.1161/JAHA.116.005334.

  • Alfredsson J, Neely B, Neely ML, Bhatt DL, Goodman SG, Tricoci P, Mahaffey KW, Cornel JH, White HD, Fox KA, Prabhakaran D, Winters KJ, Armstrong PW, Ohman EM, Roe MT; TRILOGY ACS Investigators. Predicting the risk of bleeding during dual antiplatelet therapy after acute coronary syndromes. Heart. 2017 Aug;103(15):1168-1176. doi: 10.1136/heartjnl-2016-310090. Epub 2017 Apr 5.

  • Cornel JH, Ohman EM, Neely B, Jakubowski JA, Bhatt DL, White HD, Ardissino D, Fox KA, Prabhakaran D, Armstrong PW, Erlinge D, Tantry US, Gurbel PA, Roe MT. Relationship of Platelet Reactivity With Bleeding Outcomes During Long-Term Treatment With Dual Antiplatelet Therapy for Medically Managed Patients With Non-ST-Segment Elevation Acute Coronary Syndromes. J Am Heart Assoc. 2016 Nov 4;5(11):e003977. doi: 10.1161/JAHA.116.003977.

  • Chin CT, Boden WE, Roe MT, Neely B, Neely ML, Leiva-Pons JL, Corbalan R, Gottlieb S, Dalby AJ, Armstrong PW, Prabhakaran D, Fox KA, White HD, Ohman EM, Winters KJ, Schiele F. Effect of prior clopidogrel use on outcomes in medically managed acute coronary syndrome patients. Heart. 2016 Aug 1;102(15):1221-9. doi: 10.1136/heartjnl-2015-308840. Epub 2016 Mar 30.

  • Lopes RD, Leonardi S, Neely B, Neely ML, Ohman EM, Ardissino D, Hamm CW, Goodman SG, Bhatt DL, White HD, Prabhakaran D, Martinez F, Nicolau JC, Winters KJ, Fox KA, Armstrong PW, Roe MT. Spontaneous MI After Non-ST-Segment Elevation Acute Coronary Syndrome Managed Without Revascularization: The TRILOGY ACS Trial. J Am Coll Cardiol. 2016 Mar 22;67(11):1289-97. doi: 10.1016/j.jacc.2016.01.034.

  • Doll JA, Neely ML, Roe MT, Armstrong PW, White HD, Prabhakaran D, Winters KJ, Duvvuru S, Sundseth SS, Jakubowski JA, Gurbel PA, Bhatt DL, Ohman EM, Fox KAA; TRILOGY ACS Investigators. Impact of CYP2C19 Metabolizer Status on Patients With ACS Treated With Prasugrel Versus Clopidogrel. J Am Coll Cardiol. 2016 Mar 1;67(8):936-947. doi: 10.1016/j.jacc.2015.12.036.

  • Chin CT, Neely B, Magnus Ohman E, Armstrong PW, Corbalan R, White HD, Prabhakaran D, Winters KJ, Fox KA, Roe MT; TRILOGY ACS Investigators. Time-Varying Effects of Prasugrel Versus Clopidogrel on the Long-Term Risks of Stroke After Acute Coronary Syndromes: Results From the TRILOGY ACS Trial. Stroke. 2016 Apr;47(4):1135-9. doi: 10.1161/STROKEAHA.115.012454. Epub 2016 Feb 16.

  • Roe MT, Cyr DD, Eckart D, Schulte PJ, Morse MA, Blackwell KL, Ready NE, Zafar SY, Beaven AW, Strickler JH, Onken JE, Winters KJ, Houterloot L, Zamoryakhin D, Wiviott SD, White HD, Prabhakaran D, Fox KA, Armstrong PW, Ohman EM; TRILOGY ACS Investigators. Ascertainment, classification, and impact of neoplasm detection during prolonged treatment with dual antiplatelet therapy with prasugrel vs. clopidogrel following acute coronary syndrome. Eur Heart J. 2016 Jan 21;37(4):412-22. doi: 10.1093/eurheartj/ehv611. Epub 2015 Dec 5.

  • Clemmensen P, Roe MT, Hochman JS, Cyr DD, Neely ML, McGuire DK, Cornel JH, Huber K, Zamoryakhin D, White HD, Armstrong PW, Fox KA, Prabhakaran D, Ohman EM; TRILOGY ACS Investigators. Long-term outcomes for women versus men with unstable angina/non-ST-segment elevation myocardial infarction managed medically without revascularization: insights from the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes trial. Am Heart J. 2015 Oct;170(4):695-705.e5. doi: 10.1016/j.ahj.2015.06.011. Epub 2015 Jun 20.

  • Mahaffey KW, Hager R, Wojdyla D, White HD, Armstrong PW, Alexander JH, Tricoci P, Lopes RD, Ohman EM, Roe MT, Harrington RA, Wallentin L. Meta-analysis of intracranial hemorrhage in acute coronary syndromes: incidence, predictors, and clinical outcomes. J Am Heart Assoc. 2015 Jun 18;4(6):e001512. doi: 10.1161/JAHA.114.001512.

  • Roy A, Roe MT, Neely ML, Cyr DD, Zamoryakhin D, Fox KA, White HD, Armstrong PW, Ohman EM, Prabhakaran D. Impact of Human Development Index on the profile and outcomes of patients with acute coronary syndrome. Heart. 2015 Feb;101(4):279-86. doi: 10.1136/heartjnl-2014-306389. Epub 2014 Dec 23.

  • Bakal JA, Roe MT, Ohman EM, Goodman SG, Fox KA, Zheng Y, Westerhout CM, Hochman JS, Lokhnygina Y, Brown EB, Armstrong PW. Applying novel methods to assess clinical outcomes: insights from the TRILOGY ACS trial. Eur Heart J. 2015 Feb 7;36(6):385-92a. doi: 10.1093/eurheartj/ehu262. Epub 2014 Jul 10.

  • Cornel JH, Ohman EM, Neely B, Clemmensen P, Sritara P, Zamoryakhin D, Armstrong PW, Prabhakaran D, White HD, Fox KA, Gurbel PA, Roe MT; TRILOGY ACS Investigators. Impact of smoking status on platelet function and clinical outcomes with prasugrel vs. clopidogrel in patients with acute coronary syndromes managed without revascularization: Insights from the TRILOGY ACS trial. Am Heart J. 2014 Jul;168(1):76-87.e1. doi: 10.1016/j.ahj.2014.04.011. Epub 2014 Apr 24.

  • Wiviott SD, White HD, Ohman EM, Fox KA, Armstrong PW, Prabhakaran D, Hafley G, Lokhnygina Y, Boden WE, Hamm C, Clemmensen P, Nicolau JC, Menozzi A, Ruzyllo W, Widimsky P, Oto A, Leiva-Pons J, Pavlides G, Winters KJ, Roe MT, Bhatt DL. Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment elevation myocardial infarction with or without angiography: a secondary, prespecified analysis of the TRILOGY ACS trial. Lancet. 2013 Aug 17;382(9892):605-13. doi: 10.1016/S0140-6736(13)61451-8.

  • Gurbel PA, Erlinge D, Ohman EM, Neely B, Neely M, Goodman SG, Huber K, Chan MY, Cornel JH, Brown E, Zhou C, Jakubowski JA, White HD, Fox KA, Prabhakaran D, Armstrong PW, Tantry US, Roe MT; TRILOGY ACS Platelet Function Substudy Investigators. Platelet function during extended prasugrel and clopidogrel therapy for patients with ACS treated without revascularization: the TRILOGY ACS platelet function substudy. JAMA. 2012 Nov 7;308(17):1785-94. doi: 10.1001/jama.2012.17312.

  • Roe MT, Armstrong PW, Fox KA, White HD, Prabhakaran D, Goodman SG, Cornel JH, Bhatt DL, Clemmensen P, Martinez F, Ardissino D, Nicolau JC, Boden WE, Gurbel PA, Ruzyllo W, Dalby AJ, McGuire DK, Leiva-Pons JL, Parkhomenko A, Gottlieb S, Topacio GO, Hamm C, Pavlides G, Goudev AR, Oto A, Tseng CD, Merkely B, Gasparovic V, Corbalan R, Cinteza M, McLendon RC, Winters KJ, Brown EB, Lokhnygina Y, Aylward PE, Huber K, Hochman JS, Ohman EM; TRILOGY ACS Investigators. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization. N Engl J Med. 2012 Oct 4;367(14):1297-309. doi: 10.1056/NEJMoa1205512. Epub 2012 Aug 25.

  • Jeong YH, Tantry US, Gurbel PA. Importance of potent P2Y(12) receptor blockade in acute myocardial infarction: focus on prasugrel. Expert Opin Pharmacother. 2012 Aug;13(12):1771-96. doi: 10.1517/14656566.2012.704909. Epub 2012 Jul 12.

  • Chin CT, Roe MT, Fox KA, Prabhakaran D, Marshall DA, Petitjean H, Lokhnygina Y, Brown E, Armstrong PW, White HD, Ohman EM; TRILOGY ACS Steering Committee. Study design and rationale of a comparison of prasugrel and clopidogrel in medically managed patients with unstable angina/non-ST-segment elevation myocardial infarction: the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) trial. Am Heart J. 2010 Jul;160(1):16-22.e1. doi: 10.1016/j.ahj.2010.04.022.

Related Links

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

ClopidogrelPrasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPiperazines

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2008

First Posted

June 18, 2008

Study Start

June 1, 2008

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

May 7, 2013

Results First Posted

May 7, 2013

Record last verified: 2013-03

Locations