An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome
A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome
2 other identifiers
interventional
15,526
41 countries
538
Brief Summary
The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2008
Typical duration for phase_3
538 active sites
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
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 16, 2008
CompletedFirst Posted
Study publicly available on registry
December 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
June 2, 2014
CompletedSeptember 17, 2014
August 1, 2014
2.8 years
December 16, 2008
May 5, 2014
August 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke
The percentage of patients with the first occurrence of the composite of death, myocardial infarction, or stroke. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
Secondary Outcomes (4)
The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Ischemic Stroke, or TIMI Major Bleeding Event Not Associated With Coronary Artery Bypass Graft Surgery
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
Study Arms (3)
Rivaroxaban 2.5 mg bid
EXPERIMENTALOne 2.5 mg rivaroxaban tablet twice daily for up to 6 months
Rivaroxaban 5 mg bid
EXPERIMENTALOne 5 mg rivaroxaban tablet twice daily for up to 6 months
Placebo
PLACEBO COMPARATOROne placebo tablet twice daily for up to 6 months
Interventions
Eligibility Criteria
You may qualify if:
- Patients must be currently receiving aspirin therapy alone or in combination with a thienopyridine per national or local dosing recommendation
- Have been hospitalized for symptoms suggestive of acute coronary syndrome that lasted at least 10 minutes at rest and occurred 48 hours or less before going to the hospital
You may not qualify if:
- Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding
- Need for continued anticoagulant therapy
- Significant renal impairment or known significant liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (556)
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Birmingham, Alabama, United States
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Geneva, Alabama, United States
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Mobile, Alabama, United States
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Anaheim, California, United States
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Burbank, California, United States
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Los Angeles, California, United States
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Mission Hills, California, United States
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San Diego, California, United States
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Aurora, Colorado, United States
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Littleton, Colorado, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Kissimmee, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Ormond Beach, Florida, United States
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St. Petersburg, Florida, United States
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Columbus, Georgia, United States
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Rome, Georgia, United States
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Aurora, Illinois, United States
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Indianapolis, Indiana, United States
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Merrillville, Indiana, United States
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Munster, Indiana, United States
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Valparaiso, Indiana, United States
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Overland Park, Kansas, United States
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Wichita, Kansas, United States
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Lacombe, Louisiana, United States
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Bethesda, Maryland, United States
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Boston, Massachusetts, United States
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Flint, Michigan, United States
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Grand Blanc, Michigan, United States
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Grand Rapids, Michigan, United States
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Kalamazoo, Michigan, United States
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Mount Clemens, Michigan, United States
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Petoskey, Michigan, United States
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Tupelo, Mississippi, United States
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St Louis, Missouri, United States
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Kalispell, Montana, United States
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Bridgewater, New Jersey, United States
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Linden, New Jersey, United States
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Buffalo, New York, United States
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Cortlandt Manor, New York, United States
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Saratoga Springs, New York, United States
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Stony Brook, New York, United States
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Syracuse, New York, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Fairview Park, Ohio, United States
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Bartlesville, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Doylestown, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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Ridley Park, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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West Chester, Pennsylvania, United States
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York, Pennsylvania, United States
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Greenville, South Carolina, United States
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Johnson City, Tennessee, United States
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Memphis, Tennessee, United States
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Amarillo, Texas, United States
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Lubbock, Texas, United States
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Odessa, Texas, United States
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Tomball, Texas, United States
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Salt Lake City, Utah, United States
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Burlington, Vermont, United States
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Danville, Virginia, United States
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Roanoke, Virginia, United States
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Spokane, Washington, United States
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Wausau, Wisconsin, United States
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Buenos Aires, Argentina
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Corrientes, Argentina
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Córdoba, Argentina
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Junín, Argentina
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La Plata, Argentina
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Mar del Plata, Argentina
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Morón, Argentina
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Resistencia, Argentina
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Rosario, Argentina
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Salta, Argentina
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San Luis, Argentina
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San Miguel de Tucumán, Argentina
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Santa Fe, Argentina
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Bedford Park, Australia
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Chermside, Australia
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Coffs Harbour South, Australia
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Douglas, Australia
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Epping, Australia
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Fremantle, Australia
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Heidelberg, Australia
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Herston, Australia
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Launceston, Australia
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Milton, Australia
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Newcastle, Australia
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Parkville, Australia
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Perth, Australia
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Southport, Australia
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Woolloongabba, Australia
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Bonheiden, Belgium
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Brussels, Belgium
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Eupen, Belgium
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Genk, Belgium
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Huy, Belgium
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Leuven, Belgium
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Mol, Belgium
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Tienen, Belgium
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Belo Horizonte, Brazil
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Blumenau, Brazil
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Campina Grande do Sul, Brazil
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Campinas, Brazil
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Curitiba, Brazil
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Porto Alegre, Brazil
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Recife, Brazil
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Ribeirão Preto, Brazil
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Rio de Janeiro, Brazil
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Salvador, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
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Burgas, Bulgaria
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Dimitrovgrad, Bulgaria
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Haskovo, Bulgaria
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Pazardzhik, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sevlievo, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Veliko Tarnovo, Bulgaria
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Edmonton, Alberta, Canada
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Kelowna, British Columbia, Canada
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Maple Ridge, British Columbia, Canada
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Victoria, British Columbia, Canada
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St. John's, Newfoundland and Labrador, Canada
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Greater Sudbury, Ontario, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Granby, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Saint-Georges, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Ste-Foy, Quebec, Canada
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North Battleford, Saskatchewan, Canada
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Laval, Canada
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Antofagasta, Chile
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Chile, Chile
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Osorno X Región, Chile
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Punta Arenas, Chile
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San Bernardo, Chile
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Santiago, Chile
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Santiago Rm, Chile
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Talcahuano, Chile
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Temuco, Chile
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Valdivia X Región, Chile
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Victoria, Chile
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Viña del Mar, Chile
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Beijing, China
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Beijing Prc, China
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Changsha, China
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Daqing, China
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Guangzhou, China
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Hangzhou, China
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Harbin, China
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Jinan, China
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Nanjing, China
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Shanghai, China
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Shenyang, China
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Tianjin, China
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Xi'an, China
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Armenia, Colombia
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Barranquilla, Colombia
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Bogotá Dc, Colombia
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Cali Valle Del Cauca, Colombia
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Envigado, Colombia
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Manizales, Colombia
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Medellín, Colombia
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Santander, Colombia
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Rijeka, Croatia
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Slavonski Brod, Croatia
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Suska 6, Croatia
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Benešov nad Černou, Czechia
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Brno, Czechia
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České Budějovice, Czechia
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Český Krumlov, Czechia
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Hradec Králové, Czechia
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Kolín, Czechia
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Kroměříž, Czechia
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Litomyšl, Czechia
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Náchod, Czechia
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Pardubice, Czechia
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Plzeò 1, Czechia
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Poruba, Czechia
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Prague, Czechia
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Praha 10 N/A, Czechia
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Slaný, Czechia
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Teplice, Czechia
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Ústí nad Labem, Czechia
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Znojmo, Czechia
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Aalborg, Denmark
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Copenhagen, Denmark
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Esbjerg, Denmark
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Holbæk, Denmark
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Horsens, Denmark
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Kolding, Denmark
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Odense, Denmark
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Alexandria, Egypt
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Cairo, Egypt
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Ismailia, Egypt
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Menofeya, Egypt
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Besançon, France
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Cannes, France
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Chambray-lès-Tours, France
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Chartres, France
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Créteil, France
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Dijon, France
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Haguenau, France
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Lagny, France
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Marseille, France
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Montfermeil, France
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Paris, France
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Poitiers, France
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Bad Friedrichshall, Germany
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Berlin, Germany
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Bonn, Germany
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Dresden, Germany
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Essen, Germany
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Esslingen am Neckar, Germany
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Frankfurt am Main, Germany
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Freiburg im Breisgau, Germany
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Göttingen, Germany
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Greifswald, Germany
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Halle, Germany
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Hamburg, Germany
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Hanover, Germany
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Heidelberg, Germany
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Kiel, Germany
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Leipzig, Germany
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Limburg, Germany
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Lübeck, Germany
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Magdeburg, Germany
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Mannheim, Germany
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Weiden, Germany
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Wermsdorf, Germany
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Witten, Germany
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Athens, Greece
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Larissa, Greece
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Rhodes, Greece
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Thessalonikis, Greece
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Budapest, Hungary
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Debrecen, Hungary
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Győr, Hungary
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Kecskemét, Hungary
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Komárom, Hungary
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Miskolc, Hungary
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Szolnok, Hungary
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Szombathely, Hungary
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Zalaegerszeg, Hungary
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Ahmedabad, India
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Allahabād, India
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Bangalore, India
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Chandigarh, India
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Chennai, India
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Coimbatore, India
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Ernākulam, India
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Gandhinagar Guiarat, India
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Gūrgaon, India
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Hyderabad, India
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Jaipur, India
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Karamsad, India
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Kochi, India
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Kolkata, India
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Lucknow Gpo, India
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Ludhiana, India
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Madurai, India
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Mangalore, India
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Mumbai, India
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Mysore, India
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Nagpur, India
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Nashik, India
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New Delhi, India
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Pune, India
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Surat, India
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Trissur, India
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Trivandrum, India
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Vadodara, India
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Vijayawada, India
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Afula, Israel
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Hadera, Israel
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Haifa, Israel
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Jerusalem, Israel
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Nahariya, Israel
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Petah Tikva, Israel
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Rehovot, Israel
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Safed, Israel
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Tel Aviv, Israel
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Tiberias, Israel
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Anan, Japan
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Fukui, Japan
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Fukuoka, Japan
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Fukuyama, Japan
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Gifu, Japan
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Higashiosaka, Japan
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Kagoshima, Japan
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Kanazawa, Japan
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Kasuga, Japan
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Kawachi-Nagano, Japan
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Kawasaki, Japan
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Kisarazu, Japan
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Kobe, Japan
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Kumamoto, Japan
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Kuwana, Japan
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Maebashi-City Gunma, Japan
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Matsudo, Japan
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Matsumoto, Japan
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Matsuyama-City Ehime, Japan
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Miyazaki-Gun, Japan
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Nagano, Japan
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Nagasaki, Japan
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Nagoya, Japan
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Namegata, Japan
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Nankoku, Japan
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Nishinomiya, Japan
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Okayama, Japan
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Osaka, Japan
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Sakaidechō, Japan
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Sakura-Shi, Japan
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Suwa, Japan
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Tokushima, Japan
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Tokyo, Japan
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Toyama, Japan
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Urasoe, Japan
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Yamaguchi, Japan
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Yokohama, Japan
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Yonago-Shi, Japan
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Daugavpils, Latvia
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Liepāja, Latvia
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Riga, Latvia
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Kaunas, Lithuania
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Klaipėda, Lithuania
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Šiauliai, Lithuania
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Vilnius, Lithuania
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Vilnius Lt, Lithuania
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Johor Bahru, Malaysia
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Kelantan, Malaysia
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Kota Samarahan, Malaysia
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Kuala Lumpur, Malaysia
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Selayang Baru Utara, Malaysia
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Aguascalientes, Mexico
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Cd. Juarez, Mexico
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Culiacán, Mexico
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Guadalajara, Mexico
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León, Mexico
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Mexico City, Mexico
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México, Mexico
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Monterrey, Mexico
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Querétaro, Mexico
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San Luis Potosí City, Mexico
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Sinaloa, Mexico
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Veracruz, Mexico
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Zapopan, Mexico
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Marrakesh, Morocco
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Meknes, Morocco
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Rabat, Morocco
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Amsterdam, Netherlands
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Arnhem, Netherlands
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Delft, Netherlands
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Eindhoven, Netherlands
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Gorinchem, Netherlands
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Gouda, Netherlands
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Haarlem, Netherlands
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Harderwijk, Netherlands
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Hengelo Ov, Netherlands
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Nieuwegein, Netherlands
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Nijmegen, Netherlands
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Sittard, Netherlands
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The Hague, Netherlands
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Vlaardingen, Netherlands
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Auckland, New Zealand
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Dunedin, New Zealand
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Hamilton, New Zealand
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Lower Hutt, New Zealand
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Nelson, New Zealand
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New Plymouth, New Zealand
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Iloilo City, Philippines
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Marikina City, Philippines
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Quezon City, Philippines
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Będzin, Poland
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Bialystok, Poland
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Bielsko-Biala, Poland
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Bydgoszcz, Poland
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Bytom, Poland
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Dąbrowa Górnicza, Poland
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Gdynia, Poland
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Gorlice, Poland
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Katowice, Poland
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Katowice-Ochojec, Poland
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Koszalin, Poland
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Krakow, Poland
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Kutno, Poland
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Lodz, Poland
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Nowy Targ, Poland
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Opole, Poland
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Poznan, Poland
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Płock, Poland
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Ruda Śląska, Poland
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Starogard Gdanski Nap, Poland
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Szczecin, Poland
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Torun, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Włocławek, Poland
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Zamość, Poland
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Aveiro, Portugal
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Braga, Portugal
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Coimbra, Portugal
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Faro, Portugal
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Leiria, Portugal
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Lisbon, Portugal
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Penafiel, Portugal
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Porto, Portugal
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Vila Nova de Gaia, Portugal
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Bucharest, Romania
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Craiova, Romania
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Focşani, Romania
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Oradea, Romania
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Piteşti, Romania
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Tg Mures, Romania
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Timișoara, Romania
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Arkhangelsk, Russia
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Barnaul, Russia
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Chelyabinsk, Russia
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Ivanovo, Russia
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Kaliningrad, Russia
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Kemerovo, Russia
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Kirov, Russia
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Krasnodar, Russia
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Krasnoyarsk, Russia
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Kursk, Russia
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Lyubertsy, Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Novosibirsk, Russia
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Omsk, Russia
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Orenburg, Russia
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Penza, Russia
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Perm, Russia
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Pskov, Russia
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Pushkin, Saint-Petersburg, Russia
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Ryazan, Russia
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Saint Petersburg, Russia
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Saint-Petersbrug, Russia
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Sestroretsk, Saint-Petersburg, Russia
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Syktyvkar, Russia
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Tomsk, Russia
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Tula, Russia
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Tumen Region, Russia
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Vladimir, Russia
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Voronezh, Russia
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Yaroslavl Nap, Russia
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Yekaterinburg, Russia
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Belgrade, Serbia
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Kragujevac, Serbia
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Niš, Serbia
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Niška Banja, Serbia
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Bratislava, Slovakia
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Nové Zámky, Slovakia
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Žilina, Slovakia
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Daejeon, South Korea
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Gwangju, South Korea
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Seognam-Si, Kyungki-Do, South Korea
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Seoul, South Korea
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Suwon, South Korea
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Alicante, Spain
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Aviles Asturias, Spain
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Barcelona, Spain
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Burgos, Spain
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Elche, Spain
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Figueres, Spain
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Guadalajara, Spain
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Huelva, Spain
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Madrid, Spain
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Málaga, Spain
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Salamanca, Spain
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Santander, Spain
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Seville, Spain
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Tarragona, Spain
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Valencia, Spain
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Vigo, Spain
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Danderyd, Sweden
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Gothenburg, Sweden
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Jönköping, Sweden
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Linköping, Sweden
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Lund, Sweden
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Malmo, Sweden
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Örebro, Sweden
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Östersund, Sweden
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Umeå, Sweden
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Bangkok, Thailand
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Chiang Mai, Thailand
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Pathum Thani, Thailand
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Phathumwan, Thailand
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Sfax, Tunisia
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Sousse, Tunisia
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Tunis, Tunisia
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Ankara, Turkey (Türkiye)
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Aydin, Turkey (Türkiye)
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Bursa, Turkey (Türkiye)
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Erzurum, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Kayseri, Turkey (Türkiye)
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Samsun, Turkey (Türkiye)
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Sivas, Turkey (Türkiye)
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Cherkassy, Ukraine
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Dnipro, Ukraine
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Donetsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Khemelnitskiy, Ukraine
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Kiev, Ukraine
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Luhansk, Ukraine
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Lutsk, Ukraine
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Lviv, Ukraine
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Mykolayiv, Ukraine
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Poltava, Ukraine
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Sumy, Ukraine
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Ternopil, Ukraine
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Uzhhorod, Ukraine
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Vinnitsa, Ukraine
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Zaporizhzhya, Ukraine
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Zhytomyr, Ukraine
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Birmingham, United Kingdom
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Blackpool, United Kingdom
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Bristol, United Kingdom
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Chertsey, United Kingdom
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Chesterfield, United Kingdom
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East Sussex, United Kingdom
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Exeter, United Kingdom
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Hampshire, United Kingdom
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Harrow, United Kingdom
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Hull, United Kingdom
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Leicester, United Kingdom
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Lincoln, United Kingdom
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Manchester, United Kingdom
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Middlesbrough, United Kingdom
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Portadown, United Kingdom
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Stockport, United Kingdom
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Warwick, United Kingdom
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Worcester, United Kingdom
Related Publications (8)
Chi G, AlKhalfan F, Lee JJ, Montazerin SM, Fitzgerald C, Korjian S, Omar W, Barnathan E, Plotnikov A, Gibson CM. Factors associated with early, late, and very late stent thrombosis among patients with acute coronary syndrome undergoing coronary stent placement: analysis from the ATLAS ACS 2-TIMI 51 trial. Front Cardiovasc Med. 2024 Jan 8;10:1269011. doi: 10.3389/fcvm.2023.1269011. eCollection 2023.
PMID: 38259304DERIVEDGibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8.
PMID: 31535314DERIVEDGibson CM, Levitan B, Gibson WJ, Yee MK, Murphy SA, Yuan Z, Chakrabarti AK, Lee M, Braunwald E. Fatal or Irreversible Bleeding and Ischemic Events With Rivaroxaban in Acute Coronary Syndrome. J Am Coll Cardiol. 2018 Jul 10;72(2):129-136. doi: 10.1016/j.jacc.2018.04.055.
PMID: 29976285DERIVEDCavender MA, Gibson CM, Braunwald E, Wiviott SD, Murphy SA, Toda Kato E, Plotnikov AN, Amuchastegui M, Oude Ophuis T, van Hessen M, Mega JL. The effect of rivaroxaban on myocardial infarction in the ATLAS ACS 2 - TIMI 51 trial. Eur Heart J Acute Cardiovasc Care. 2015 Oct;4(5):468-74. doi: 10.1177/2048872614554109. Epub 2014 Oct 15.
PMID: 25318481DERIVEDGibson CM, Chakrabarti AK, Mega J, Bode C, Bassand JP, Verheugt FW, Bhatt DL, Goto S, Cohen M, Mohanavelu S, Burton P, Stone G, Braunwald E; ATLAS-ACS 2 TIMI 51 Investigators. Reduction of stent thrombosis in patients with acute coronary syndromes treated with rivaroxaban in ATLAS-ACS 2 TIMI 51. J Am Coll Cardiol. 2013 Jul 23;62(4):286-90. doi: 10.1016/j.jacc.2013.03.041. Epub 2013 Apr 16.
PMID: 23602776DERIVEDMega JL, Braunwald E, Murphy SA, Plotnikov AN, Burton P, Kiss RG, Parkhomenko A, Tendera M, Widimsky P, Gibson CM. Rivaroxaban in patients stabilized after a ST-segment elevation myocardial infarction: results from the ATLAS ACS-2-TIMI-51 trial (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome-Thrombolysis In Myocardial Infarction-51). J Am Coll Cardiol. 2013 May 7;61(18):1853-9. doi: 10.1016/j.jacc.2013.01.066. Epub 2013 Mar 7.
PMID: 23500262DERIVEDMega JL, Braunwald E, Wiviott SD, Bassand JP, Bhatt DL, Bode C, Burton P, Cohen M, Cook-Bruns N, Fox KA, Goto S, Murphy SA, Plotnikov AN, Schneider D, Sun X, Verheugt FW, Gibson CM; ATLAS ACS 2-TIMI 51 Investigators. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med. 2012 Jan 5;366(1):9-19. doi: 10.1056/NEJMoa1112277. Epub 2011 Nov 13.
PMID: 22077192DERIVEDGibson CM, Mega JL, Burton P, Goto S, Verheugt F, Bode C, Plotnikov A, Sun X, Cook-Bruns N, Braunwald E. Rationale and design of the Anti-Xa therapy to lower cardiovascular events in addition to standard therapy in subjects with acute coronary syndrome-thrombolysis in myocardial infarction 51 (ATLAS-ACS 2 TIMI 51) trial: a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rivaroxaban in subjects with acute coronary syndrome. Am Heart J. 2011 May;161(5):815-821.e6. doi: 10.1016/j.ahj.2011.01.026.
PMID: 21570509DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Development Head Cardiovascular/Urology
- Organization
- Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- 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
December 16, 2008
First Posted
December 17, 2008
Study Start
November 1, 2008
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
September 17, 2014
Results First Posted
June 2, 2014
Record last verified: 2014-08