A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart
An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention
2 other identifiers
interventional
4,614
35 countries
615
Brief Summary
The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K antagonist, such as warfarin, with or without aspirin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2015
Longer than P75 for phase_4
615 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
First Submitted
Initial submission to the registry
April 9, 2015
CompletedFirst Posted
Study publicly available on registry
April 14, 2015
CompletedStudy Start
First participant enrolled
June 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2018
CompletedResults Posted
Study results publicly available
February 7, 2020
CompletedJune 11, 2020
June 1, 2020
3.4 years
April 9, 2015
November 7, 2019
June 9, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period
Time to first ISTH major or CRNM bleeding during the 6-month period of treatment with Apixaban or VKA. N is the number of participants treated with Apixaban or VKA. n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with major or CRNM bleeding divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
Approximately 6 months
The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period
Time to first ISTH major or CRNM bleeding during the treatment period of 6 months with aspirin or placebo. N is the number of participants with aspirin or placebo. n is the number of participants treated with aspirin or placebo with major or CRNM bleeding in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
Approximately 6 months
Secondary Outcomes (5)
Superiority on ISTH Major or CRNM Bleeding for Apixaban Versus VKA
Approximately 6 months
The Rate of All-cause Death or All-cause Rehospitalization With Apixaban Versus VKA
Approximately 6 months
The Rate of All-cause Death or All-cause Rehospitalization With Aspirn Versus no Aspirin
Approximately 6 months
The Rate of the Composite Endpoint of Death or Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Apixaban Versus VKA
Approximately 6 months
The Composite Endpoints of Death and Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Aspirin Versus no Aspirin
Approximately 6 months
Study Arms (4)
Apixaban
ACTIVE COMPARATOR5 mg or 2.5 mg Apixaban tablets orally twice per day
Vitamin K Antagonist
ACTIVE COMPARATORVKA tablets orally once daily
Acetylsalicylic acid film coated tablet
PLACEBO COMPARATOR81 mg Acetylsalicylic acid film coated tablet orally once daily
Placebo matching Acetylsalicylic acid film coated tablet
PLACEBO COMPARATORPlacebo matching Acetylsalicylic acid film coated tablet once daily
Interventions
Eligibility Criteria
You may qualify if:
- Adults with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. In addition, subjects must have had an acute coronary syndrome or percutaneous coronary intervention with a stent within the prior 14 days
- Planned use of antiplatelet agents for at least 1 to 6 months
- Males and Females ≥ 18 years of age
- Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug
You may not qualify if:
- Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve)
- Severe renal insufficiency (serum creatinine \> 2.5 mg/dL or a calculated creatinine clearance \< 30 mL/min
- Patients with a history of intracranial hemorrhage
- Patients have had or will undergo Coronary arterial bypass graft (CABG) for their index acute coronary syndrome (ACS) event
- Patients with known ongoing bleeding and patients with known coagulopathies
- Any contraindications or allergies to VKA, apixaban, or to intended P2Y12 antagonists or to aspirin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Pfizercollaborator
- Duke Clinical Research Institutecollaborator
Study Sites (626)
Cardiovascular Associates of the Southeast, LLC
Birmingham, Alabama, 35243, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3410, United States
Arizona Heart Rhythm Center
Phoenix, Arizona, 85013, United States
Local Institution
Phoenix, Arizona, 85054, United States
Scottsdale Osborn Medical Center
Scottsdale, Arizona, 85251, United States
Southern Arizona VA Health Care System
Tucson, Arizona, 85723, United States
Local Institution
Little Rock, Arkansas, 72204, United States
Local Institution
Phoenix, Arkansas, 85015, United States
Comprehensive Cardiovascular Specialists
Alhambra, California, 91801, United States
Local Institution
Culver City, California, 90230, United States
Washington Township Medical Foundation
Fremont, California, 94536, United States
California Heart Specialist, Inc.
Huntington Beach, California, 92648, United States
Foundation For Cardiovascular Medicine
La Jolla, California, 92037, United States
Local Institution
Long Beach, California, 90806, United States
Local Institution
Rancho Mirage, California, 92270, United States
Local Institution
San Diego, California, 92161, United States
Manshadi Heart Institute
Stockton, California, 95204, United States
Local Institution
Torrance, California, 90502, United States
University Of Colorado
Aurora, Colorado, 80045, United States
Colorado Heart and Vascular
Lakewood, Colorado, 80228, United States
Local Institution
Norwalk, Connecticut, 06851, United States
Local Institution
Wilmington, Delaware, 19803, United States
Orlando Heart Specialists
Altamonte Springs, Florida, 32714, United States
Local Institution
Bradenton, Florida, 34209, United States
Clearwater Cardiovascular and Interventional Consultants
Clearwater, Florida, 33756, United States
Local Institution
Clearwater, Florida, 33756, United States
Daytona Heart Group
Daytona Beach, Florida, 32114, United States
Local Institution
Fort Lauderdale, Florida, 33316, United States
Local Institution
Jacksonville, Florida, 32204, United States
Local Institution
Jacksonville, Florida, 32216, United States
Local Institution
Jacksonville Beach, Florida, 32250, United States
Tenet Florida Physician Services
Jupiter, Florida, 33458, United States
Local Institution
Lake Mary, Florida, 32746, United States
Local Institution
Miami, Florida, 33173, United States
Mediquest Research
Ocala, Florida, 34471, United States
Local Institution
Orlando, Florida, 32825, United States
CP Cardiology Partners
Palm Beach Gardens, Florida, 33410, United States
Bayfront Health St. Petersburg
St. Petersburg, Florida, 33701, United States
Local Institution
Tampa, Florida, 33613, United States
Cardiology Partners
Wellington, Florida, 33449, United States
Athens Regional Cariology Group
Athens, Georgia, 30606, United States
Local Institution
Atlanta, Georgia, 30342, United States
Augusta University
Augusta, Georgia, 30912, United States
Georgia Heart Specialists
Covington, Georgia, 30014, United States
Local Institution
Cumming, Georgia, 30041, United States
Local Institution
Tucker, Georgia, 30084, United States
Saint Lukes Idaho Cardiology Associates
Boise, Idaho, 83712, United States
Medicoricium, LLC
Fairview Heights, Illinois, 62208, United States
Gateway Cardiology PC
Jerseyville, Illinois, 62052, United States
Advocate Medical Group ? Cardiology and Pulmonology
Normal, Illinois, 61761, United States
South Suburban Cardiology
Olympia Fields, Illinois, 60461, United States
Local Institution
Bloomington, Indiana, 47403, United States
Elkhart Clinic LLC
Elkhart, Indiana, 46514, United States
Roudebush VA Medical Center
Indianapolis, Indiana, 46202, United States
Reid Hospital and Health Care Services
Richmond, Indiana, 47374, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52803, United States
University of Iowa Stead Family Children's Hospital
Iowa City, Iowa, 52242, United States
Northeast Iowa Family Practice Center
Waterloo, Iowa, 50702, United States
Local Institution
Kansas City, Kansas, 66160, United States
Local Institution
Wichita, Kansas, 67203, United States
Saint Elizabeth Healthcare
Crestview Hills, Kentucky, 41017, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Alexandria Cardiology Clinic
Alexandria, Louisiana, 71301, United States
Imperial Health
Lake Charles, Louisiana, 70601, United States
Local Institution
Minden, Louisiana, 71055, United States
Clinical Trials of America LA LLC - PPDS
Monroe, Louisiana, 71201, United States
Local Institution
Natick, Massachusetts, 01760, United States
Great Lakes Heart Center of Alpena
Alpena, Michigan, 49707, United States
Local Institution
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Local Institution
Detroit, Michigan, 48202, United States
Local Institution
Lansing, Michigan, 48912, United States
Covenant Center for the Heart
Saginaw, Michigan, 48602, United States
Metropolitan Cardiology Consultants
Minneapolis, Minnesota, 55433-4568, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Local Institution
Jackson, Mississippi, 39216, United States
Cardiology Associates Research LLC
Tupelo, Mississippi, 38801, United States
Missouri Cardiovascular Specialists
Columbia, Missouri, 65201, United States
Local Institution
Columbia, Missouri, 65212, United States
Freeman Health System
Joplin, Missouri, 64804, United States
Cox Health Systems
Springfield, Missouri, 65807, United States
Gateway Cardiology PC
St Louis, Missouri, 63128, United States
St. Louis Heart and Vascular
St Louis, Missouri, 63136, United States
Local Institution
Billings, Montana, 59101, United States
Bryan Heart Hospital
Lincoln, Nebraska, 68506, United States
HCP Clinical Research LLC
Las Vegas, Nevada, 89169, United States
Renown Regional Medical Center.
Reno, Nevada, 89502, United States
New Jersey Heart
Linden, New Jersey, 07036, United States
Capital Cardiology Associates
Albany, New York, 12211, United States
New York-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Local Institution
Brooklyn, New York, 11217, United States
Buffalo Heart Group LLP
Buffalo, New York, 14215, United States
Mount Sinai-St. Lukes
New York, New York, 10025, United States
Hudson Valley Cardiovascular Practice, PC
Poughkeepsie, New York, 12601, United States
Asheville Cardiology Associates PA
Asheville, North Carolina, 28801, United States
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599, United States
Durham VA Medical Center
Durham, North Carolina, 27705, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Clinical Trials of America-NC, LLC - PPDS
Lenoir, North Carolina, 28645, United States
Duke Cardiology and Cardiovascular Surgery of Lumberton
Lumberton, North Carolina, 28358, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
Aultman Hospital
Canton, Ohio, 44710, United States
Local Institution
Columbus, Ohio, 43214, United States
Local Institution
Kettering, Ohio, 45429, United States
Local Institution
Willoughby, Ohio, 44094, United States
Saint Vincent Hospital
Erie, Pennsylvania, 16544, United States
Heart Group
Lancaster, Pennsylvania, 17603, United States
Mercer Bucks Cardiology
Newton, Pennsylvania, 18940, United States
WellSpan York Hospital
York, Pennsylvania, 17405, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Columbia Heart
Columbia, South Carolina, 29204, United States
Upstate Cardiology PA
Greenville, South Carolina, 29607, United States
Roper St. Francis Healthcare
North Charleston, South Carolina, 29418, United States
Carolina Cardiology Clinical Research Institute
Rock Hill, South Carolina, 29732, United States
Local Institution
Germantown, Tennessee, 38138, United States
Research Associates of Jackson
Jackson, Tennessee, 38301, United States
Cardiovascular Research of Knoxville
Knoxville, Tennessee, 37917, United States
Knoxville Health Managment Associates Cardiology PPM LLC
Knoxville, Tennessee, 37934, United States
Parkway Cardiology Associates PC
Oak Ridge, Tennessee, 37830, United States
Local Institution
Austin, Texas, 78705, United States
Local Institution
Austin, Texas, 78758, United States
Local Institution
Dallas, Texas, 75216, United States
San Antonio Military Medical Center
Fort Sam Houston, Texas, 78234, United States
Angiocardiac Care of Texas PA
Houston, Texas, 77025, United States
Local Institution
Houston, Texas, 77084, United States
Local Institution
Houston, Texas, 77089, United States
Grace Research, LLC
Huntsville, Texas, 77340, United States
Local Institution
Huntsville, Texas, 77340, United States
Local Institution
Katy, Texas, 77450, United States
Caprock Cardiac Center Research Institute
Lubbock, Texas, 79410, United States
Local Institution
Plano, Texas, 75024, United States
Local Institution
San Antonio, Texas, 78229, United States
Mercury Medical LLC
San Antonio, Texas, 78229, United States
Local Institution
Sealy, Texas, 77474, United States
Local Institution
Sugar Land, Texas, 77479, United States
Victoria Heart and Vascular Center
Victoria, Texas, 77901, United States
University of Vermont
Burlington, Vermont, 05403, United States
Virginia Heart
Falls Church, Virginia, 22042, United States
Virginia Heart Group Ltd
Leesburg, Virginia, 20176, United States
CJW Medical Center
Richmond, Virginia, 23235, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
St Mary's Medical Center
Huntington, West Virginia, 25702, United States
Aspirus Research Institute
Wausau, Wisconsin, 54401, United States
Local Institution
Buenos Aires, BUA, 1180, Argentina
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Bahía Blanca, Buenos Aires, B8000FTD, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, 1406, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, 1431, Argentina
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Coronel Suárez, Buenos Aires, B7540DOL, Argentina
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Lanús Oeste, Buenos Aires, 4843, Argentina
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Mar del Plata, Buenos Aires, 7500, Argentina
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Mar del Plata, Buenos Aires, B7602CBM, Argentina
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Quilmes, Buenos Aires, 1878, Argentina
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Quilmes, Buenos Aires, B1878GEG, Argentina
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Ramos Mejía, Buenos Aires, B1704ESN, Argentina
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Ramos Mejía, Buenos Aires, B1704ETD, Argentina
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Vicente López, Buenos Aires, B1602ABQ, Argentina
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Resistencia, Chaco Province, H3500CDL, Argentina
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Córdoba, Córdoba Province, X5000JHGQ, Argentina
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Villa Allende, Córdoba Province, 5105, Argentina
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Villa María, Córdoba Province, X5901ACH, Argentina
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Rosario, Santa Fe Province, 2000, Argentina
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Rosario, Santa Fe Province, S2000DSV, Argentina
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Rosario, Santa Fe Province, S2000PBJ, Argentina
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Buenos Aires, 1118, Argentina
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Buenos Aires, 1430, Argentina
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Buenos Aires, C1093AAS, Argentina
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Buenos Aires, C1155ADP, Argentina
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Buenos Aires, C1179AAB, Argentina
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Buenos Aires, C1221ADC, Argentina
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Buenos Aires, C1425AGC, Argentina
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Buenos Aires, C1428CRC, Argentina
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Buenos Aires, C1428DCO, Argentina
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Corrientes, W3400AMZ, Argentina
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Córdoba, 5000, Argentina
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Córdoba, 5016, Argentina
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Córdoba, X5000AAX, Argentina
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Córdoba, X5000EPU, Argentina
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Córdoba, X5002AOQ, Argentina
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Córdoba, X5004CDT, Argentina
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Córdoba, X5006CBI, Argentina
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Córdoba, X5008KKF, Argentina
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Córdoba, X5016KEH, Argentina
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Santa Fe, 3000, Argentina
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Santa Fe, S3000AOL, Argentina
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Santa Fe, S3000EOZ, Argentina
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Santiago del Estero, Argentina
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Concord, New South Wales, 2139, Australia
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Port Macquarie, New South Wales, 2444, Australia
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Milton, Queensland, 4064, Australia
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Elizabeth Vale, South Australia, 5112, Australia
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Bedford Park, 5024, Australia
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Graz, 8020, Austria
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Graz, 8036, Austria
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Linz, 4010, Austria
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Linz, 4021, Austria
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Vienna, 1100, Austria
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Vienna, 1160, Austria
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Vienna, A-1090, Austria
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Aalst, 9300, Belgium
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Antwerp, 2020, Belgium
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Bonheiden, 2820, Belgium
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Brasschaat, 2930, Belgium
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Brussels, 1000, Belgium
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Ghent, 9000, Belgium
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Ieper, 8900, Belgium
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Leuven, 3000, Belgium
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Wilrijk, 2610, Belgium
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Yvoir, 5530, Belgium
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Colatina, Espírito Santo, 29702-020, Brazil
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Salvador, Estado de Bahia, 40050-410, Brazil
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Salvador, Estado de Bahia, 41253-190, Brazil
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Salvador, Estado de Bahia, 41810-011, Brazil
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Salvador, Estado de Bahia, 41950-275, Brazil
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Brasília, Federal District, 70390-700, Brazil
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Aparecida de Goiânia, Goiás, 74915-520, Brazil
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Goiânia, Goiás, 74210-050, Brazil
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Belo Horizonte, Minas Gerais, 30110-921, Brazil
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Belo Horizonte, Minas Gerais, 30150-320, Brazil
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Uberaba, Minas Gerais, 38025-260, Brazil
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Uberlândia, Minas Gerais, 38400-902, Brazil
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Campina Grande do Sul, Paraná, 83430-000, Brazil
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Londrina, Paraná, 86010-450, Brazil
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Belém, Pará, 66087-660, Brazil
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Recife, Pernambuco, 50100-060, Brazil
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Recife, Pernambuco, 52051-380, Brazil
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Canoas, Rio Grande do Sul, 92425-900, Brazil
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Passo Fundo, Rio Grande do Sul, 99010-080, Brazil
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Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
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Porto Alegre, Rio Grande do Sul, 90620-001, Brazil
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Porto Alegre, Rio Grande do Sul, 90840-440, Brazil
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Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
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Blumenau, Santa Catarina, 89010-906, Brazil
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Itajaí, Santa Catarina, 88301-303, Brazil
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Campinas, São Paulo, 13060080, Brazil
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Limeira, São Paulo, 13480-470, Brazil
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Marília, São Paulo, 17515-000, Brazil
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S?o Paulo, São Paulo, 01327-010, Brazil
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S?o Paulo, São Paulo, 04004-030, Brazil
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S?o Paulo, São Paulo, 08270-070, Brazil
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Santo André, São Paulo, 09030-010, Brazil
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São José do Rio Preto, São Paulo, 15015-750, Brazil
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Votuporanga, São Paulo, 15500-003, Brazil
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Rio de Janeiro, 22271-100, Brazil
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São Paulo, 01418-100, Brazil
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São Paulo, 05403-000, Brazil
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Burgas, 8000, Bulgaria
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Dimitrovgrad, 6400, Bulgaria
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Haskovo, 6300, Bulgaria
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Montana, 3400, Bulgaria
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Pazardzhik, 4400, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4002, Bulgaria
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Sandanski, 2800, Bulgaria
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Smolyan, 4700, Bulgaria
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Sofia, 1202, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1505, Bulgaria
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Sofia, 1527, Bulgaria
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Sofia, 1606, Bulgaria
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Veliko Tarnova, 5000, Bulgaria
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Vidin, 3700, Bulgaria
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Edmonton, Alberta, T5H 3V9, Canada
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Edmonton, Alberta, T6G 2B7, Canada
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Edmonton, Alberta, T6K 4C1, Canada
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Kelowna, British Columbia, V1Y 1V6, Canada
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New Westminster, British Columbia, V3L 3W4, Canada
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Victoria, British Columbia, V8R 4R2, Canada
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Winnepeg, Manitoba, R2H 2A6, Canada
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Halifax, Nova Scotia, B3H1V7, Canada
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Cambridge, Ontario, N1R 7R1, Canada
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Greater Sudbury, Ontario, P3E 3B8, Canada
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Greater Sudbury, Ontario, P3E 5M4, Canada
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London, Ontario, N6A 5A5, Canada
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Oshawa, Ontario, L1J 2J9, Canada
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Scarborough Village, Ontario, M1E 5E9, Canada
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Scarborough Village, Ontario, M1P 2T7, Canada
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Waterloo, Ontario, N2T 0C1, Canada
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Green Field Park, Quebec, J4V 2H1, Canada
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Laval, Quebec, H7M 3L9, Canada
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Longueuil, Quebec, J4M 2X1, Canada
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Montreal, Quebec, H3G 1A4, Canada
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Saint-Jean-sur-Richelieu, Quebec, J3A 1C3, Canada
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Saint-Jérôme, Quebec, J7Z 5T3, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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St-Georges, Beauce, Quebec, G5Y 4T8, Canada
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Regina, Saskatchewan, S4P 0W5, Canada
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Montreal, H2X 3E4, Canada
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Santiago, Santiago Metropolitan, 7500588, Chile
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Barranquilla, 84-176, Colombia
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Barranquilla, Colombia
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Bogotá, Colombia
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Cali, 760032, Colombia
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Espinal, Colombia
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Medellín, Colombia
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Čakovec, 40000, Croatia
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Dubrovnik, 20000, Croatia
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Karlovac, 47000, Croatia
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Krapinske Toplice, 49217, Croatia
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Opatija, 51410, Croatia
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Osijek, 31000, Croatia
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Rijeka, 51000, Croatia
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Slavonski Brod, 35000, Croatia
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Šibenik, 22000, Croatia
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Virovitica, 33000, Croatia
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Zabok, 49210, Croatia
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Zadar, 23000, Croatia
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Zagreb, 10000, Croatia
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Prague, 128 08, Czechia
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Prague, 150 06, Czechia
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Prague, 180 85, Czechia
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Tábor, 390 03, Czechia
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Ústí nad Orlicí, 562 18, Czechia
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Zlín, 762 75, Czechia
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Aabenraa, 6200, Denmark
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Aarhus, 8000, Denmark
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Copenhagen, DK-2300, Denmark
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Frederiksburg, 2000, Denmark
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Hellerup, DK-2900, Denmark
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Hillerød, DK-3400, Denmark
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Holb?k, DK-4300, Denmark
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Hvidovre, DK-2650, Denmark
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Randers, 8900, Denmark
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Roskilde, DK-4000, Denmark
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Slagelse, DK-4200, Denmark
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Besançon, 25000, France
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Caen, 14033, France
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Chambray-lès-Tours, 37170, France
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Le Coudray, 28360, France
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Lyon, 69365, France
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Marseille, 13385, France
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Nîmes, 30029, France
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Pau, 64000, France
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Pessac, 33604, France
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Toulouse, 31059, France
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Bad Friedrichshall, 74177, Germany
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Bad Homburg, 61348, Germany
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Bad Homburg, 63148, Germany
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Berlin, 12351, Germany
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Berlin, 13347, Germany
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Berlin, 13353, Germany
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Bielefeld, 33604, Germany
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Brandenburg, 14770, Germany
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Bremen, 28277, Germany
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Chemnitz, 09111, Germany
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Cologne, 50937, Germany
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Dortmund, 44137, Germany
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Dresden, 01067, Germany
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Dresden, 01277, Germany
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Erfurt, 99089, Germany
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Erfurt, 99097, Germany
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Erlangen, 91054, Germany
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Essen, 45122, Germany
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Frankfurt am Main, 65929, Germany
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Freiburg im Breisgau, 79106, Germany
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Göttingen, 37075, Germany
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Greifswald, 17475, Germany
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Hamburg, 20099, Germany
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Hamburg, 22041, Germany
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Hennigsdorf, 16761, Germany
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Hoyerswerda, 02977, Germany
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Jena, 07747, Germany
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Karlsbad, 76307, Germany
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Kassel, 34121, Germany
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Lahr, 77933, Germany
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Leipzig, 04103, Germany
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Limburg, 65549, Germany
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Lübeck, 23538, Germany
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Lüdenscheid, 58515, Germany
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Magdeburg, 39120, Germany
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Mainz, 55131, Germany
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Mannheim, 68167, Germany
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Regensburg, 93053, Germany
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Rostock, 18057, Germany
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Stendal, 39576, Germany
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Straubing, 94315, Germany
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Tübingen, 72076, Germany
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Worms, 67550, Germany
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San Luis Potosí City, Mexico
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Niš, 18000, Serbia
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Busan, 49241, South Korea
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Majadahonda, Madrid, 28222, Spain
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Alicante, ?03010, Spain
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Barcelona, 08036, Spain
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Córdoba, 14004, Spain
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Donostia / San Sebastian, 20080, Spain
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Huelva, 21005, Spain
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Madrid, 28007, Spain
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Madrid, 28031, Spain
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Madrid, 28034, Spain
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Madrid, 28040, Spain
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Marbella, 29603, Spain
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Málaga, 29010, Spain
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Palma de Mallorca, 07198, Spain
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Valencia, 46010, Spain
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Valencia, 46014, Spain
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Eskilstuna, 63188, Sweden
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Gothenburg, 413 45, Sweden
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Jönköping, 551 85, Sweden
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Östersund, SE-83183, Sweden
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Skellefteå, 931 81, Sweden
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Stockholm, 112 81, Sweden
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Uppsala, 755 92, Sweden
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Bern, 3010, Switzerland
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Geneva, 1205, Switzerland
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Winterthur, 8401, Switzerland
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Cherkasy, 18009, Ukraine
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Chernivtsi, 58013, Ukraine
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Dnipropetrovsk, 49006, Ukraine
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Ivano-Frankivsk, 76018, Ukraine
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Kharkiv, 61058, Ukraine
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Kharkiv, 61103, Ukraine
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Kharkiv, 61176, Ukraine
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Kyiv, 02091, Ukraine
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Kyiv, 03049, Ukraine
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Kyiv, 03680, Ukraine
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Lutsk, 43005, Ukraine
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Lutsk, 43024, Ukraine
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Mykolaiv, 54003, Ukraine
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Odesa, 65014, Ukraine
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Uzhhorod, 88014, Ukraine
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Vinnytsia, 21005, Ukraine
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Vinnytsia, 21029, Ukraine
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Zhaporizhzhya, 69000, Ukraine
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Related Publications (15)
Fudim M, Lopes RD, Wojdyla DM, Mehran R, Khan MS, Granger CB, Goodman SG, Aronson R, Windecker S, Alexander JH. Apixaban Dose in Patients With Atrial Fibrillation and Acute Coronary Syndrome and/or Undergoing Percutaneous Coronary Intervention: Insights From AUGUSTUS. JACC Adv. 2025 Apr;4(4):101665. doi: 10.1016/j.jacadv.2025.101665. Epub 2025 Mar 20.
PMID: 40117694DERIVEDTannu M, Lopes RD, Wojdyla DM, Goodman SG, Aronson R, Mehran R, Granger CB, Windecker S, Alexander JH, Jones WS. Antithrombotic Therapy to Minimize Total Events After ACS or PCI in Atrial Fibrillation: Insights From AUGUSTUS. J Am Coll Cardiol. 2025 Mar 25;85(11):1157-1168. doi: 10.1016/j.jacc.2024.10.125. Epub 2025 Feb 5.
PMID: 39918467DERIVEDFanaroff AC, Vora AN, Wojdyla DM, Mehran R, Granger CB, Goodman SG, Aronson R, Windecker S, Alexander JH, Lopes RD. Effect of apixaban versus vitamin K antagonist and aspirin versus placebo on days alive and out of hospital: An analysis from AUGUSTUS. Am Heart J. 2025 Feb;280:60-69. doi: 10.1016/j.ahj.2024.11.005. Epub 2024 Nov 17.
PMID: 39557109DERIVEDFanaroff AC, Wojdyla DM, Granger CB, Goodman SG, Aronson RS, Windecker S, Mehran R, Alexander JH, Lopes RD. Relative Benefit of Dual Versus Single Antiplatelet Therapy Among Patients With Atrial Fibrillation on Oral Anticoagulation According to Time After ACS and PCI: Insights From the AUGUSTUS Trial. Circ Cardiovasc Interv. 2024 Nov;17(11):e013596. doi: 10.1161/CIRCINTERVENTIONS.123.013596. Epub 2024 Nov 6.
PMID: 39502066DERIVEDBerwanger O, Wojdyla DM, Fanaroff AC, Budaj A, Granger CB, Mehran R, Aronson R, Windecker S, Goodman SG, Alexander JH, Lopes RD. Antithrombotic Strategies in Atrial Fibrillation After ACS and/or PCI: A 4-Way Comparison From AUGUSTUS. J Am Coll Cardiol. 2024 Sep 3;84(10):875-885. doi: 10.1016/j.jacc.2024.06.022.
PMID: 39197976DERIVEDGuimaraes PO, Lopes RD, Wojdyla DM, Alexander JH, Goodman SG, Aronson R, Halvorsen S, Sinnaeve P, Vinereanu D, Storey RF, Berwanger O, Windecker S, Mehran R, Granger CB, Alexander KP; AUGUSTUS Investigators. Antithrombotic Strategies According to Age: Insights from the AUGUSTUS Trial. Am J Med. 2024 Oct;137(10):958-965. doi: 10.1016/j.amjmed.2024.06.001. Epub 2024 Jun 13.
PMID: 38876331DERIVEDBahit MC, Vora AN, Li Z, Wojdyla DM, Thomas L, Goodman SG, Aronson R, Jordan JD, Kolls BJ, Dombrowski KE, Vinereanu D, Halvorsen S, Berwanger O, Windecker S, Mehran R, Granger CB, Alexander JH, Lopes RD. Apixaban or Warfarin and Aspirin or Placebo After Acute Coronary Syndrome or Percutaneous Coronary Intervention in Patients With Atrial Fibrillation and Prior Stroke: A Post Hoc Analysis From the AUGUSTUS Trial. JAMA Cardiol. 2022 Jul 1;7(7):682-689. doi: 10.1001/jamacardio.2022.1166.
PMID: 35612866DERIVEDWelsh RC, Dehghani P, Lopes R, Wojdyla DM, Aronson R, Granger CB, Windecker S, Vora AN, Vinereanu D, Halvorsen S, Parkhomenko A, Mehran R, Alexander JH, Goodman S. Impact of prior oral anticoagulant use and outcomes on patients from secondary analysis in the AUGUSTUS trial. Open Heart. 2022 Feb;9(1):e001892. doi: 10.1136/openhrt-2021-001892.
PMID: 35172988DERIVEDHarskamp RE, Fanaroff AC, Lopes RD, Wojdyla DM, Goodman SG, Thomas LE, Aronson R, Windecker S, Mehran R, Granger CB, Alexander JH. Antithrombotic Therapy in Patients With Atrial Fibrillation After Acute Coronary Syndromes or Percutaneous Intervention. J Am Coll Cardiol. 2022 Feb 8;79(5):417-427. doi: 10.1016/j.jacc.2021.11.035.
PMID: 35115097DERIVEDHijazi Z, Alexander JH, Li Z, Wojdyla DM, Mehran R, Granger CB, Parkhomenko A, Bahit MC, Windecker S, Aronson R, Berwanger O, Halvorsen S, de Waha-Thiele S, Sinnaeve P, Darius H, Storey RF, Lopes RD. Apixaban or Vitamin K Antagonists and Aspirin or Placebo According to Kidney Function in Patients With Atrial Fibrillation After Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial. Circulation. 2021 Mar 23;143(12):1215-1223. doi: 10.1161/CIRCULATIONAHA.120.051020. Epub 2021 Jan 19.
PMID: 33461308DERIVEDAlexander JH, Wojdyla D, Vora AN, Thomas L, Granger CB, Goodman SG, Aronson R, Windecker S, Mehran R, Lopes RD. Risk/Benefit Tradeoff of Antithrombotic Therapy in Patients With Atrial Fibrillation Early and Late After an Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From AUGUSTUS. Circulation. 2020 May 19;141(20):1618-1627. doi: 10.1161/CIRCULATIONAHA.120.046534. Epub 2020 Mar 29.
PMID: 32223444DERIVEDLopes RD, Leonardi S, Wojdyla DM, Vora AN, Thomas L, Storey RF, Vinereanu D, Granger CB, Goodman SG, Aronson R, Windecker S, Thiele H, Valgimigli M, Mehran R, Alexander JH. Stent Thrombosis in Patients With Atrial Fibrillation Undergoing Coronary Stenting in the AUGUSTUS Trial. Circulation. 2020 Mar 3;141(9):781-783. doi: 10.1161/CIRCULATIONAHA.119.044584. Epub 2019 Nov 11. No abstract available.
PMID: 31707833DERIVEDWindecker S, Lopes RD, Massaro T, Jones-Burton C, Granger CB, Aronson R, Heizer G, Goodman SG, Darius H, Jones WS, Aschermann M, Brieger D, Cura F, Engstrom T, Fridrich V, Halvorsen S, Huber K, Kang HJ, Leiva-Pons JL, Lewis BS, Malaga G, Meneveau N, Merkely B, Milicic D, Morais J, Potpara TS, Raev D, Sabate M, de Waha-Thiele S, Welsh RC, Xavier D, Mehran R, Alexander JH; AUGUSTUS Investigators. Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial. Circulation. 2019 Dec 3;140(23):1921-1932. doi: 10.1161/CIRCULATIONAHA.119.043308. Epub 2019 Sep 26.
PMID: 31557056DERIVEDLopes RD, Heizer G, Aronson R, Vora AN, Massaro T, Mehran R, Goodman SG, Windecker S, Darius H, Li J, Averkov O, Bahit MC, Berwanger O, Budaj A, Hijazi Z, Parkhomenko A, Sinnaeve P, Storey RF, Thiele H, Vinereanu D, Granger CB, Alexander JH; AUGUSTUS Investigators. Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation. N Engl J Med. 2019 Apr 18;380(16):1509-1524. doi: 10.1056/NEJMoa1817083. Epub 2019 Mar 17.
PMID: 30883055DERIVEDLopes RD, Vora AN, Liaw D, Granger CB, Darius H, Goodman SG, Mehran R, Windecker S, Alexander JH. An open-Label, 2 x 2 factorial, randomized controlled trial to evaluate the safety of apixaban vs. vitamin K antagonist and aspirin vs. placebo in patients with atrial fibrillation and acute coronary syndrome and/or percutaneous coronary intervention: Rationale and design of the AUGUSTUS trial. Am Heart J. 2018 Jun;200:17-23. doi: 10.1016/j.ahj.2018.03.001. Epub 2018 Mar 9.
PMID: 29898844DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2015
First Posted
April 14, 2015
Study Start
June 4, 2015
Primary Completion
November 10, 2018
Study Completion
November 10, 2018
Last Updated
June 11, 2020
Results First Posted
February 7, 2020
Record last verified: 2020-06