Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
COMPASS
A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease (COMPASS - Cardiovascular OutcoMes for People Using Anticoagulation StrategieS).
2 other identifiers
interventional
27,395
33 countries
565
Brief Summary
The primary objectives of this study are:
- To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD);
- To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2013
Longer than P75 for phase_3
565 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
January 24, 2013
CompletedFirst Posted
Study publicly available on registry
January 28, 2013
CompletedStudy Start
First participant enrolled
February 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2017
CompletedResults Posted
Study results publicly available
October 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2021
CompletedNovember 28, 2022
November 1, 2022
4.4 years
January 24, 2013
July 16, 2018
November 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death
Count of participants and time from randomization to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria
Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day). Count of participants and time from randomization to the first occurrence of the primary safety outcome major bleeding were evaluated. Hazard ratios were calculated and reported as statistical analysis.
For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
Secondary Outcomes (3)
The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death
For each participant, the first occurrence of MI, ALI, or CHD death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
The First Occurrence of MI, Ischemic Stroke, ALI, or Cardiovascular (CV) Death
For each participant, the first occurrence of MI, ischemic stroke, ALI, or CV death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
All-cause Mortality
For each participants, death by any cause after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
Other Outcomes (3)
The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death in LTOLE Part
For each participant, the first occurrence of the composite primary efficacy outcome after from COMPASS LTOLE initiation visit up until last LTOLE part contact date was considered. The mean time in follow-up was 428 days.
The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria in LTOLE Part
For each participant, the first occurrence of modified ISTH major bleeding from COMPASS LTOLE initiation visit up until 2 days after the last treatment in LTOLE part was considered. The mean time in follow-up was 421 days.
All-cause Mortality in LTOLE Part
For each participants, death by any cause after COMPASS LTOLE initiation visit up until the the last LTOLE part contact date was considered. The mean time in follow-up until that date was 428 days.
Study Arms (3)
Rivaroxaban 2.5mg + Aspirin 100mg
EXPERIMENTALParticipants received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
Rivaroxaban 5mg + Aspirin Placebo
EXPERIMENTALParticipants received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
Rivaroxaban Placebo + Aspirin 100mg
ACTIVE COMPARATORParticipants received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
Interventions
Tablet, 2.5 mg, twice daily, oral
Tablet, 100 mg, once daily, oral
Rivaroxaban matching placebo, twice daily, oral
Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole
Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo
Eligibility Criteria
You may qualify if:
- \- Meet criteria for CAD and/or PAD
- Subjects with CAD must also meet at least one of the following criteria:
- Age ≥65, or
- Age \<65 and documented atherosclerosis or revascularization involving at least 2 vascular beds, or at least 2 additional risk factors
You may not qualify if:
- Stroke within 1 month or any history of hemorrhagic or lacunar stroke
- Severe heart failure with known ejection fraction \<30% or New York Heart Association (NYHA) class III or IV symptoms
- Estimated glomerular filtration rate (eGFR)\<15 mL/min
- Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Population Health Research Institutecollaborator
- Janssen Research & Development, LLCcollaborator
Study Sites (565)
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Birmingham, Alabama, 35294, United States
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Mobile, Alabama, 36608, United States
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Anaheim, California, 92801, United States
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Laguna Hills, California, 92653, United States
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Northridge, California, 91324, United States
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Palo Alto, California, 94304-1207, United States
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Santa Rosa, California, 95494, United States
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Sylmar, California, 91342, United States
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Torrance, California, 90502-2004, United States
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Norwalk, Connecticut, 06851, United States
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Stamford, Connecticut, 06905, United States
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Trumbull, Connecticut, 06611, United States
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Atlantis, Florida, 33462, United States
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Clearwater, Florida, 33756, United States
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Coral Springs, Florida, 33065, United States
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Jacksonville Beach, Florida, 32250, United States
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Largo, Florida, 33770, United States
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New Port Richey, Florida, 34653, United States
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Safety Harbor, Florida, 34695, United States
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Sarasota, Florida, 34239, United States
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Meridian, Idaho, 83716, United States
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Arlington Heights, Illinois, 60005, United States
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Hazel Crest, Illinois, 60429, United States
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Davenport, Iowa, 52803, United States
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West Des Moines, Iowa, 50266, United States
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Crestview Hills, Kentucky, 41017-5460, United States
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Baltimore, Maryland, 21215, United States
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Haverhill, Massachusetts, 01830, United States
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Alpena, Michigan, 49707, United States
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Jackson, Michigan, 49201, United States
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St Louis, Missouri, 63136, United States
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Kalispell, Montana, 59901, United States
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New Brunswick, New Jersey, 08901, United States
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Cortlandt Manor, New York, 10567, United States
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Kingston, New York, 12401, United States
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Saratoga Springs, New York, 12866, United States
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Durham, North Carolina, 27713, United States
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Pinehurst, North Carolina, 28374, United States
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Elyria, Ohio, 44035, United States
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Sandusky, Ohio, 44870, United States
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Toledo, Ohio, 43606, United States
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Doylestown, Pennsylvania, 18901, United States
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Langhorne, Pennsylvania, 19047, United States
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Yardley, Pennsylvania, 19067, United States
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Sioux Falls, South Dakota, 57108, United States
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Dallas, Texas, 75216-7167, United States
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Houston, Texas, 77030-4298, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78229, United States
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Bellevue, Washington, 98004-4623, United States
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Puyallup, Washington, 98372, United States
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Seattle, Washington, 98195, United States
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Spokane, Washington, 99204, United States
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Adrogué, Buenos Aires, 1846, Argentina
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Bahía Blanca, Buenos Aires, 8000, Argentina
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Coronel Suárez, Buenos Aires, B7540GHD, Argentina
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Junín, Buenos Aires, B6000BHA, Argentina
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La Plata, Buenos Aires, 1900, Argentina
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La Plata, Buenos Aires, B1902AGY, Argentina
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La Plata, Buenos Aires, B1902CNF, Argentina
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La Plata, Buenos Aires, B1902COS, Argentina
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Mar del Plata, Buenos Aires, B7600FZN, Argentina
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Merlo, Buenos Aires, B1722COV, Argentina
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Munro, Buenos Aires, B1605DSX, Argentina
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Quilmes, Buenos Aires, 1878, Argentina
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Ramos Mejía, Buenos Aires, B1740ETD, Argentina
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San Martín, Buenos Aires, 1650, Argentina
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San Nicolás de los Arroyos, Buenos Aires, B2900DMH, Argentina
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Vicente López, Buenos Aires, B1602ABQ, Argentina
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Zárate, Buenos Aires, B2800DGH, Argentina
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Buenos Aires, Ciudad Auton. de Buenos Aires, C1119ACN, Argentina
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Buenos Aires, Ciudad Auton. de Buenos Aires, C1428ART, Argentina
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Buenos Aires, Ciudad Auton. de Buenos Aires, C1440AAD, Argentina
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Ciudad Autón. de Buenos Aires, Ciudad Auton. de Buenos Aires, C1425AGC, Argentina
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Villa Allende, Córdoba Province, Argentina
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Villa María, Córdoba Province, X5900JKA, Argentina
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Santa Rosa, La Pampa Province, 6300, Argentina
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Rafaela, Santa Fe Province, S2300MMA, Argentina
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Rosario, Santa Fe Province, 2000, Argentina
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Rosario, Santa Fe Province, S2005PAF, Argentina
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Rosario, Santa Fe Province, Argentina
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Venado Tuerto, Santa Fe Province, S2600KUE, Argentina
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San Miguel de Tucumán, Tucumán Province, 4000, Argentina
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San Miguel de Tucumán, Tucumán Province, T4000IFL, Argentina
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Ciudad Auton. de Buenos Aires, C1023AAB, Argentina
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Ciudad Auton. de Buenos Aires, C1181ACL, Argentina
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Ciudad Auton. de Buenos Aires, C1405BUB, Argentina
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Corrientes, 3400, Argentina
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Córdoba, X5000AAW Córdoba, Argentina
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Córdoba, X5000AAX, Argentina
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Córdoba, X5003DCE, Argentina
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Córdoba, X5003DCP, Argentina
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Córdoba, X5004CDT, Argentina
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Córdoba, X5006IKK, Argentina
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Salta, A4406CLA, Argentina
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San Juan, 5400, Argentina
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San Luis, 5700, Argentina
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Santa Fe, S3000FWO, Argentina
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Bruce, Australian Capital Territory, 2617, Australia
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Gosford, New South Wales, 2250, Australia
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New Lambton Heights, New South Wales, 2305, Australia
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Taree, New South Wales, 2430, Australia
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Birtinya, Queensland, 4575, Australia
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Brisbane, Queensland, 4029, Australia
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Brisbane, Queensland, 4064, Australia
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Redcliffe, Queensland, 4020, Australia
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Woolloongabba, Queensland, 4102, Australia
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Adelaide, South Australia, 5042, Australia
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Hobart, Tasmania, 7000, Australia
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Launceston, Tasmania, 7250, Australia
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Geelong, Victoria, 3220, Australia
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Melbourne, Victoria, 3052, Australia
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Melbourne, Victoria, 3181, Australia
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Prahran, Victoria, 3181, Australia
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Murdoch, Western Australia, 6150, Australia
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Nedlands, Western Australia, 6009, Australia
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Antwerp, 2020, Belgium
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Bonheiden, 2820, Belgium
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Bruges, 8000, Belgium
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Bruxelles - Brussel, 1070, Belgium
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Charleroi, 6000, Belgium
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Genk, 3600, Belgium
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Hasselt, 3500, Belgium
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Kortrijk, 8500, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Roeselare, 8800, Belgium
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Goiânia, Goiás, 74223 130, Brazil
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Belo Horizonte, Minas Gerais, 30150-240, Brazil
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Uberaba, Minas Gerais, 38025-260, Brazil
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Uberlândia, Minas Gerais, 38400-368, Brazil
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Campina Grande do Sul, Paraná, 83430 000, Brazil
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Curitiba, Paraná, 80730-150, Brazil
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Canoas, Rio Grande do Sul, 92425-900, Brazil
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Pelotas, Rio Grande do Sul, 96015-290, Brazil
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Porto Alegre, Rio Grande do Sul, 90.620-001, Brazil
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Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
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Porto Alegre, Rio Grande do Sul, 90840-440, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Blumenau, Santa Catarina, 89010 500, Brazil
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Campinas, São Paulo, 13010-001, Brazil
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Campinas, São Paulo, 13020-421, Brazil
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Campinas, São Paulo, 13060904, Brazil
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Matão, São Paulo, 15990-060, Brazil
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São José do Rio Preto, São Paulo, 15015-750, Brazil
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São José do Rio Preto, São Paulo, 15090, Brazil
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São Paulo, São Paulo, 01506-001, Brazil
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São Paulo, São Paulo, 04012-909, Brazil
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Votuporanga, São Paulo, Brazil
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São Paulo, 05403-000, Brazil
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Calgary, Alberta, T2N 4Z6, Canada
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Edmonton, Alberta, T6G 2B7, 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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Winnipeg, Manitoba, R2H 0R8, Canada
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Winnipeg, Manitoba, R2H 2A6, Canada
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Winnipeg, Manitoba, R2V 4W3, Canada
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Winnipeg, Manitoba, R3T 2E8, Canada
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Moncton, New Brunswick, E1G 1A7, Canada
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Saint John, New Brunswick, E2L 4L2, Canada
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Halifax, Nova Scotia, B3H 3A7, Canada
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Brampton, Ontario, L6W 2X7, Canada
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Burlington, Ontario, L7M 4Y1, Canada
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Burlington, Ontario, L7R 1E2, Canada
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Cambridge, Ontario, N1R 6V6, Canada
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Cambridge, Ontario, N1R 7R1, Canada
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Greater Sudbury, Ontario, P3E 1H5, Canada
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Greater Sudbury, Ontario, P3E 6C3, Canada
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Grimsby, Ontario, L3M 1P3, Canada
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Hamilton, Ontario, L8L 2X2, Canada
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Hamilton, Ontario, L8M 1K7, Canada
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London, Ontario, N6A 5A5, Canada
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London, Ontario, N6G 2M1, Canada
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Mississauga, Ontario, L5K 2L3, Canada
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Newmarket, Ontario, L3Y 2P6, Canada
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Newmarket, Ontario, L3Y 8C3, Canada
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Oakville, Ontario, L6K 3W7, Canada
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Oshawa, Ontario, L1J 2J9, Canada
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Oshawa, Ontario, L1J 2K1, Canada
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Ottawa, Ontario, K2H 8T5, Canada
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Peterborough, Ontario, K9J 0B2, Canada
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Scarborough Village, Ontario, M1E 5E9, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Waterloo, Ontario, ON N2T 0C1, Canada
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Windsor, Ontario, N8X 5A6, Canada
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Chicoutimi, Quebec, G7H 5H6, Canada
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Laval, Quebec, H7M 3L9, Canada
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Lévis, Quebec, G6V 4Z5, Canada
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Montreal, Quebec, H2W 1T8, Canada
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Montreal, Quebec, H3G 1A4, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Terrebonne, Quebec, J6V 2H2, Canada
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Thetford-Mines, Quebec, G6G 2V4, Canada
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Trois-Rivières, Quebec, G8Z 4K4, Canada
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Ontario, P3E 5M4, Canada
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Québec, G1V 4G5, Canada
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Concepción, Bío-Bío, 4070038, Chile
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Osorno, Los Lagos Region, 5311092, Chile
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Valdivia, Los Lagos Region, Chile
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Temuco, Región de la Araucanía, 2170000, Chile
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Temuco, Región de la Araucanía, 4781156, Chile
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Temuco, Región de la Araucanía, 4791348, Chile
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Viña del Mar, Región de Valparaíso, 2570017, Chile
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Providencia, Santiago Metropolitan, 7500520, Chile
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San Miguel, Santiago Metropolitan, 8910108, Chile
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Santiago, 7500739, Chile
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Santiago, Chile
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Guangzhou, Guangdong, 510080, China
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Guangzhou, Guangdong, 510100, China
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Wudan, Hubei, 430022, China
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Wuhan, Hubei, China
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Changsha, Hunan, 410011, China
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Nanjing, Jiangsu, 210006, China
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Nanjing, Jiangsu, 210029, China
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Changchun, Jilin, 130000, China
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Changchun, Jilin, 130033, China
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Shenyang, Liaoning, 110004, China
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Xi’an, Shanxi, 710061, China
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Chengdu, Sichuan, 610041, China
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Hangzhou, Zhejiang, 310003, China
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Hangzhou, Zhejiang, 310016, China
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Wenzhou, Zhejiang, 325000, China
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Beijing, 100029, China
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Beijing, 100034, China
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Beijing, 100038, China
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Beijing, 100088, China
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Beijing, 100730, China
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Beijing, China
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Shanghai, 200001, China
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Shanghai, 200003, China
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Shanghai, 200025, China
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Shanghai, 200030, China
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Shanghai, 200032, China
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Shanghai, 200080, China
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Barranquilla, Atlántico, Colombia
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Manizales, Caldas Department, Colombia
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Cartagena, Departamento de Bolívar, Colombia
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Montería, Departamento de Córdoba, 230002, Colombia
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Pasto, Departamento de Nariño, Colombia
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Armenia, Quindío Department, Colombia
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Pereira, Risaralda Department, Colombia
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Bucaramanga, Santander Department, Colombia
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Floridablanca, Santander Department, 681004, Colombia
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Espinal, Tolima Department, Colombia
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Cali, Valle del Cauca Department, 760032, Colombia
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Barranquilla, Colombia
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Bogotá, Colombia
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Brno, 625 00, Czechia
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Brno, 656 91, Czechia
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České Budějovice, 370 01, Czechia
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Český Krumlov, 381 27, Czechia
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Hodonín, 695 01, Czechia
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Hradec Králové, 500 05, Czechia
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Jablonec nad Nisou, 466 60, Czechia
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Kolín, 280 02, Czechia
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Liberec, 460 63, Czechia
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Olomouc, 779 00, Czechia
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Ostrava, 708 52, Czechia
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Ostrava, 728 80, Czechia
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Pardubice, 530 03, Czechia
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Prague, 100 34, Czechia
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Prague, 128 08, Czechia
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Prague, 140 21, Czechia
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Prague, 150 06, Czechia
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Prague, 150 30, Czechia
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Prague, 158 00, Czechia
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Prague, 169 02, Czechia
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Slaný, 274 01, Czechia
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Sušice, 342 01, Czechia
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Třebíč, 674 01, Czechia
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Třinec, 739 61, Czechia
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Uherské Hradiště, 686 68, Czechia
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Zlín, 762 75, Czechia
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Aalborg, DK-9000, Denmark
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Aarhus N, 8200, Denmark
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Copenhagen, DK-2400, Denmark
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Hellerup, 2900, Denmark
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Holbæk, 4300, Denmark
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Hvidovre, 2650, Denmark
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Kolding, 6000, Denmark
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København Ø, 2100, Denmark
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Viborg, 8800, Denmark
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Guayaquil, Guayas, Ecuador
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Quito, Pichincha, 0, Ecuador
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Quito, Ecuador
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Kuopio, 70100, Finland
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Kuusankoski, 45700, Finland
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Tampere, 33200, Finland
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Turku, FIN-20520, Finland
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Vantaa, 01600, Finland
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Amiens, 80054, France
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Clermont-Ferrand, 63000, France
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Limoges, 87042, France
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Montpellier, 34059, France
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Nice, 06280, France
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Nîmes, 30029, France
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Paris, 75012, France
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Paris, 75018, France
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Paris, 75908, France
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Saint-Priest-en-Jarez, 42270, France
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Nuremberg, Bavaria, 90402, Germany
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Würzburg, Bavaria, 97078, Germany
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Bad Homburg, Hesse, 61348, Germany
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Frankfurt am Main, Hesse, 60596, Germany
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Kassel, Hesse, 34128, Germany
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Bielefeld, North Rhine-Westphalia, 33604, Germany
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Dortmund, North Rhine-Westphalia, 44137, Germany
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Wuppertal, North Rhine-Westphalia, 42117, Germany
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Dresden, Saxony, 01067, Germany
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Leipzig, Saxony, 04289, Germany
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Magdeburg, Saxony-Anhalt, 39120, Germany
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Berlin, 12351, Germany
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Berlin, 12559, Germany
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Berlin, 13353, Germany
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Bottrop, 46242, Germany
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Frankfurt, 65929, Germany
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Hamburg, 20099, Germany
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Warendorf, 48231, Germany
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Balatonfüred, 8230, Hungary
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Budapest, 1085, Hungary
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Budapest, 1115, Hungary
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Budapest, H-1096, Hungary
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Budapest, H-1125, Hungary
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Debrecen, 4032, Hungary
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Mosonmagyaróvár, 9200, Hungary
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Pécs, 7624, Hungary
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Sopron, 9400, Hungary
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Szekszárd, 7100, Hungary
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Székesfehérvár, 8000, Hungary
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Ballinasloe, Co. Galway, Ireland
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Cork, Ireland
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Dublin, 9, Ireland
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Dublin, D07 R2WY, Ireland
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Dublin, D08 NHY1, Ireland
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Galway, Ireland
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Afula, 1834111, Israel
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Ashkelon, 7830604, Israel
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Bnei Brak, Israel
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Haifa, 3109601, Israel
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Haifa, 3436212, Israel
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Holon, 5822012, Israel
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Nahariya, 2210001, Israel
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Safed, 1311001, Israel
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Tel Aviv, 64239, Israel
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Tel Aviv, Israel
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Foggia, Apulia, 71100, Italy
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Lecce, Apulia, 73042, Italy
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Caserta, Campania, 81027, Italy
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Londonderry Co. Londonderry, Derry, BT47 6SB, United Kingdom
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Related Publications (68)
Eikelboom JW, Bosch J, Connolly SJ, Tyrwitt J, Fox KAA, Muehlhofer E, Neumann C, Tasto C, Bangdiwala SI, Diaz R, Alings M, Dagenais GR, Leong DP, Lonn EM, Avezum A, Piegas LS, Widimsky P, Parkhomenko AN, Bhatt DL, Branch KRH, Probstfield JL, Lopez-Jaramillo P, Ryden L, Pogosova N, Keltai K, Keltai M, Ertl G, Stoerk S, Dans AL, Lanas F, Liang Y, Zhu J, Torp-Pedersen C, Maggioni AP, Commerford PJ, Guzik TJ, Vanassche T, Verhamme P, O'Donnell M, Tonkin AM, Varigos JD, Vinereanu D, Felix C, Kim JH, Ibrahim KS, Lewis BS, Metsarinne KP, Aboyans V, Steg PG, Hori M, Kakkar A, Anand SS, Lamy A, Sharma M, Yusuf S. Long-Term Treatment with the Combination of Rivaroxaban and Aspirin in Patients with Chronic Coronary or Peripheral Artery Disease: Outcomes During the Open Label Extension of the COMPASS trial. Eur Heart J Cardiovasc Pharmacother. 2022 Dec 2;8(8):786-795. doi: 10.1093/ehjcvp/pvac023.
PMID: 35383832BACKGROUNDAnand SS, Caron F, Eikelboom JW, Bosch J, Dyal L, Aboyans V, Abola MT, Branch KRH, Keltai K, Bhatt DL, Verhamme P, Fox KAA, Cook-Bruns N, Lanius V, Connolly SJ, Yusuf S. Major Adverse Limb Events and Mortality in Patients With Peripheral Artery Disease: The COMPASS Trial. J Am Coll Cardiol. 2018 May 22;71(20):2306-2315. doi: 10.1016/j.jacc.2018.03.008. Epub 2018 Mar 11.
PMID: 29540326RESULTAnand SS, Bosch J, Eikelboom JW, Connolly SJ, Diaz R, Widimsky P, Aboyans V, Alings M, Kakkar AK, Keltai K, Maggioni AP, Lewis BS, Störk S, Zhu J, Lopez-Jaramillo P, O'Donnell M, Commerford PJ, Vinereanu D, Pogosova N, Ryden L, Fox KAA, Bhatt DL, Misselwitz F, Varigos JD, Vanassche T, Avezum AA, Chen E, Branch K, Leong DP, Bangdiwala SI, Hart RG, Yusuf S. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 Nov 10. pii: S0140-6736(17)32409-1. doi: 10.1016/S0140-6736(17)32409-1. PMID:29132880
RESULTConnolly SJ, Eikelboom JW, Bosch J, Dagenais G, Dyal L, Lanas F, Metsarinne K, O'Donnell M, Dans AL, Ha JW, Parkhomenko AN, Avezum AA, Lonn E, Lisheng L, Torp-Pedersen C, Widimsky P, Maggioni AP, Felix C, Keltai K, Hori M, Yusoff K, Guzik TJ, Bhatt DL, Branch KRH, Cook Bruns N, Berkowitz SD, Anand SS, Varigos JD, Fox KAA, Yusuf S. Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 Nov 10. pii: S0140-6736(17)32458-3. doi: 10.1016/S0140-6736(17)32458-3. PMID:29132879
RESULTEikelboom JW, Connolly SJ, Bosch J, Dagenais GR, Hart RG, Shestakovska O, Diaz R, Alings M, Lonn EM, Anand SS, Widimsky P, Hori M, Avezum A, Piegas LS, Branch KRH, Probstfield J, Bhatt DL, Zhu J, Liang Y, Maggioni AP, Lopez-Jaramillo P, O'Donnell M, Kakkar AK, Fox KAA, Parkhomenko AN, Ertl G, Stork S, Keltai M, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Tonkin AM, Lewis BS, Felix C, Yusoff K, Steg PG, Metsarinne KP, Cook Bruns N, Misselwitz F, Chen E, Leong D, Yusuf S; COMPASS Investigators. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease. N Engl J Med. 2017 Oct 5;377(14):1319-1330. doi: 10.1056/NEJMoa1709118. Epub 2017 Aug 27.
PMID: 28844192RESULTBosch J, Eikelboom JW, Connolly SJ, Bruns NC, Lanius V, Yuan F, Misselwitz F, Chen E, Diaz R, Alings M, Lonn EM, Widimsky P, Hori M, Avezum A, Piegas LS, Bhatt DL, Branch KRH, Probstfield JL, Liang Y, Liu L, Zhu J, Maggioni AP, Lopez-Jaramillo P, O'Donnell M, Fox KAA, Kakkar A, Parkhomenko AN, Ertl G, Stork S, Keltai K, Keltai M, Ryden L, Dagenais GR, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Ha JW, Tonkin AM, Varigos JD, Lewis BS, Felix C, Yusoff K, Steg PG, Aboyans V, Metsarinne KP, Anand SS, Hart RG, Lamy A, Moayyedi P, Leong DP, Sharma M, Yusuf S. Rationale, Design and Baseline Characteristics of Participants in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) Trial. Can J Cardiol. 2017 Aug;33(8):1027-1035. doi: 10.1016/j.cjca.2017.06.001. Epub 2017 Jun 8.
PMID: 28754388RESULTBraunwald E. An Important Step for Thrombocardiology. N Engl J Med. 2017 Oct 5;377(14):1387-1388. doi: 10.1056/NEJMe1710241. Epub 2017 Aug 27. No abstract available.
PMID: 28844176RESULTFauchier L, Bisson A, Angoulvant D. Rivaroxaban in Stable Cardiovascular Disease. N Engl J Med. 2018 Jan 26;378(4):395. doi: 10.1056/NEJMc1714934. No abstract available.
PMID: 29372976RESULTBerger JS. Antithrombotic therapy in peripheral artery disease. Lancet. 2018 Jan 20;391(10117):183-184. doi: 10.1016/S0140-6736(17)32847-7. Epub 2017 Nov 10. No abstract available.
PMID: 29132877RESULTDarmon A, Bhatt DL, Elbez Y, Aboyans V, Anand S, Bosch J, Branch KR, Connolly SJ, Dyal L, Eikelboom JW, Fox KAA, Keltai K, Probstfield J, Yusuf S, Abtan J, Sorbets E, Eagle KA, Ducrocq G, Steg PG. External applicability of the COMPASS trial: an analysis of the reduction of atherothrombosis for continued health (REACH) registry. Eur Heart J. 2018 Mar 1;39(9):750-757a. doi: 10.1093/eurheartj/ehx658.
PMID: 29186454RESULTVerheugt FWA. Return of Oral Anticoagulation in Chronic Stable Coronary Disease. Circulation. 2018 Apr 17;137(16):1655-1657. doi: 10.1161/CIRCULATIONAHA.117.032916. No abstract available.
PMID: 29661947RESULTFox KAA, Eikelboom JW, Anand SS, Bhatt DL, Bosch J, Connolly SJ, Harrington RA, Steg PG, Yusuf S. Anti-thrombotic options for secondary prevention in patients with chronic atherosclerotic vascular disease: what does COMPASS add? Eur Heart J. 2019 May 7;40(18):1466-1471. doi: 10.1093/eurheartj/ehy347. No abstract available.
PMID: 29945212RESULTSharma M, Hart RG, Smith EE, Bosch J, Yuan F, Casanova A, Eikelboom JW, Connolly SJ, Wong G, Diaz R, Lopez-Jaramillo P, Ertl G, Stork S, Dagenais GR, Lonn EM, Ryden L, Tonkin AM, Varigos JD, Bhatt DL, Branch KR, Probstfield JL, Kim JH, Ha JW, O'Donnell M, Vinereanu D, Fox KA, Liang Y, Liu L, Zhu J, Pogosova N, Maggioni AP, Avezum A, Piegas LS, Keltai K, Keltai M, Cook Bruns N, Berkowitz S, Yusuf S. Rationale, design, and baseline participant characteristics in the MRI and cognitive substudy of the cardiovascular outcomes for people using anticoagulation strategies trial. Int J Stroke. 2019 Apr;14(3):270-281. doi: 10.1177/1747493018784478. Epub 2018 Jul 30.
PMID: 30058959RESULTKruger PC, Eikelboom JW, Yusuf S. Rivaroxaban with or without aspirin for prevention of cardiovascular disease. Coron Artery Dis. 2018 Aug;29(5):361-365. doi: 10.1097/MCA.0000000000000605. No abstract available.
PMID: 29346127RESULTAdemi Z, Zomer E, Tonkin A, Liew D. Cost-effectiveness of rivaroxaban and aspirin compared to aspirin alone in patients with stable cardiovascular disease: An Australian perspective. Int J Cardiol. 2018 Nov 1;270:54-59. doi: 10.1016/j.ijcard.2018.06.091. Epub 2018 Jun 25.
PMID: 30220379RESULTBhagirath VC, Eikelboom JW, Anand SS. Low-dose rivaroxaban plus aspirin for the prevention of cardiovascular events: an evaluation of COMPASS. Future Cardiol. 2018 Nov;14(6):443-453. doi: 10.2217/fca-2018-0059. Epub 2018 Nov 12.
PMID: 30417662RESULTKruger PC, Anand SS, de Vries TAC, Eikelboom JW. Patients with Peripheral Artery Disease in the COMPASS Trial. Eur J Vasc Endovasc Surg. 2018 Dec;56(6):772-773. doi: 10.1016/j.ejvs.2018.08.010. Epub 2018 Sep 10. No abstract available.
PMID: 30213508RESULTBoden WE, Bhatt DL. Will COMPASS Point to a New Direction in Thrombotic Risk Reduction in Patients With Stable Cardiovascular Disease? Circulation. 2018 Aug 28;138(9):858-860. doi: 10.1161/CIRCULATIONAHA.118.035405. No abstract available.
PMID: 30354448RESULTLamy A, Eikelboom J, Sheth T, Connolly S, Bosch J, Fox KAA, Zhu J, Lonn E, Dagenais G, Widimsky P, Branch KRH, Bhatt DL, Zheng Z, Straka Z, Dagenais F, Kong Y, Marsden T, Lee SF, Copland I, Yusuf S. Rivaroxaban, Aspirin, or Both to Prevent Early Coronary Bypass Graft Occlusion: The COMPASS-CABG Study. J Am Coll Cardiol. 2019 Jan 22;73(2):121-130. doi: 10.1016/j.jacc.2018.10.048.
PMID: 30654882RESULTSharma M, Hart RG, Connolly SJ, Bosch J, Shestakovska O, Ng KKH, Catanese L, Keltai K, Aboyans V, Alings M, Ha JW, Varigos J, Tonkin A, O'Donnell M, Bhatt DL, Fox K, Maggioni A, Berkowitz SD, Bruns NC, Yusuf S, Eikelboom JW. Stroke Outcomes in the COMPASS Trial. Circulation. 2019 Feb 26;139(9):1134-1145. doi: 10.1161/CIRCULATIONAHA.118.035864.
PMID: 30667279RESULTCoppens M, Weitz JI, Eikelboom JWA. Synergy of Dual Pathway Inhibition in Chronic Cardiovascular Disease. Circ Res. 2019 Feb;124(3):416-425. doi: 10.1161/CIRCRESAHA.118.313141.
PMID: 30702997RESULTMoayyedi P, Eikelboom JW, Bosch J, Connolly SJ, Dyal L, Shestakovska O, Leong D, Anand SS, Stork S, Branch KRH, Bhatt DL, Verhamme PB, O'Donnell M, Maggioni AP, Lonn EM, Piegas LS, Ertl G, Keltai M, Cook Bruns N, Muehlhofer E, Dagenais GR, Kim JH, Hori M, Steg PG, Hart RG, Diaz R, Alings M, Widimsky P, Avezum A, Probstfield J, Zhu J, Liang Y, Lopez-Jaramillo P, Kakkar A, Parkhomenko AN, Ryden L, Pogosova N, Dans A, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik T, Vinereanu D, Tonkin AM, Lewis BS, Felix C, Yusoff K, Metsarinne K, Fox KAA, Yusuf S; COMPASS Investigators. Pantoprazole to Prevent Gastroduodenal Events in Patients Receiving Rivaroxaban and/or Aspirin in a Randomized, Double-Blind, Placebo-Controlled Trial. Gastroenterology. 2019 Aug;157(2):403-412.e5. doi: 10.1053/j.gastro.2019.04.041. Epub 2019 May 2.
PMID: 31054846RESULTFox KAA, Eikelboom JW, Shestakovska O, Connolly SJ, Metsarinne KP, Yusuf S. Rivaroxaban Plus Aspirin in Patients With Vascular Disease and Renal Dysfunction: From the COMPASS Trial. J Am Coll Cardiol. 2019 May 14;73(18):2243-2250. doi: 10.1016/j.jacc.2019.02.048.
PMID: 31072566RESULTCairns JA, Eikelboom JW, Shestakovska O, Yusuf S, DeMets D. Monitoring Emerging Data From the COMPASS Trial of an Antithrombotic Agent. J Am Coll Cardiol. 2019 Jun 4;73(21):2769-2772. doi: 10.1016/j.jacc.2019.03.479. No abstract available.
PMID: 31146821RESULTMoayyedi P, Eikelboom JW, Bosch J, Connolly SJ, Dyal L, Shestakovska O, Leong D, Anand SS, Stork S, Branch KRH, Bhatt DL, Verhamme PB, O'Donnell M, Maggioni AP, Lonn EM, Piegas LS, Ertl G, Keltai M, Bruns NC, Muehlhofer E, Dagenais GR, Kim JH, Hori M, Steg PG, Hart RG, Diaz R, Alings M, Widimsky P, Avezum A, Probstfield J, Zhu J, Liang Y, Lopez-Jaramillo P, Kakkar AK, Parkhomenko AN, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Vinereanu D, Tonkin AM, Lewis BS, Felix C, Yusoff K, Metsarinne KP, Fox KAA, Yusuf S; COMPASS Investigators. Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin. Gastroenterology. 2019 Sep;157(3):682-691.e2. doi: 10.1053/j.gastro.2019.05.056. Epub 2019 May 29.
PMID: 31152740RESULTKruger PC, Guzik TJ, Eikelboom JW. How can the results of the COMPASS trial benefit patients with coronary or peripheral artery disease in Poland? Kardiol Pol. 2019 Aug 23;77(7-8):661-669. doi: 10.33963/KP.14855. Epub 2019 May 30.
PMID: 31144674RESULTBranch KR, Probstfield JL, Eikelboom JW, Bosch J, Maggioni AP, Cheng RK, Bhatt DL, Avezum A, Fox KAA, Connolly SJ, Shestakovska O, Yusuf S. Rivaroxaban With or Without Aspirin in Patients With Heart Failure and Chronic Coronary or Peripheral Artery Disease. Circulation. 2019 Aug 13;140(7):529-537. doi: 10.1161/CIRCULATIONAHA.119.039609. Epub 2019 Jun 5.
PMID: 31163978RESULTDarmon A, Sorbets E, Ducrocq G, Elbez Y, Abtan J, Popovic B, Ohman EM, Rother J, Wilson PF, Montalescot G, Zeymer U, Bhatt DL, Steg PG; REACH Registry Investigators. Association of Multiple Enrichment Criteria With Ischemic and Bleeding Risks Among COMPASS-Eligible Patients. J Am Coll Cardiol. 2019 Jul 2;73(25):3281-3291. doi: 10.1016/j.jacc.2019.04.046.
PMID: 31248549RESULTAnand SS, Eikelboom JW, Dyal L, Bosch J, Neumann C, Widimsky P, Avezum AA, Probstfield J, Cook Bruns N, Fox KAA, Bhatt DL, Connolly SJ, Yusuf S; COMPASS Trial Investigators. Rivaroxaban Plus Aspirin Versus Aspirin in Relation to Vascular Risk in the COMPASS Trial. J Am Coll Cardiol. 2019 Jul 2;73(25):3271-3280. doi: 10.1016/j.jacc.2019.02.079.
PMID: 31248548RESULTFox KAA, Metra M, Morais J, Atar D. The myth of 'stable' coronary artery disease. Nat Rev Cardiol. 2020 Jan;17(1):9-21. doi: 10.1038/s41569-019-0233-y. Epub 2019 Jul 29.
PMID: 31358978RESULTde Vries TI, Eikelboom JW, Bosch J, Westerink J, Dorresteijn JAN, Alings M, Dyal L, Berkowitz SD, van der Graaf Y, Fox KAA, Visseren FLJ. Estimating individual lifetime benefit and bleeding risk of adding rivaroxaban to aspirin for patients with stable cardiovascular disease: results from the COMPASS trial. Eur Heart J. 2019 Dec 7;40(46):3771-3778a. doi: 10.1093/eurheartj/ehz404.
PMID: 31504399RESULTEikelboom JW, Connolly SJ, Bosch J, Shestakovska O, Aboyans V, Alings M, Anand SS, Avezum A, Berkowitz SD, Bhatt DL, Cook-Bruns N, Felix C, Fox KAA, Hart RG, Maggioni AP, Moayyedi P, O'Donnell M, Ryden L, Verhamme P, Widimsky P, Zhu J, Yusuf S. Bleeding and New Cancer Diagnosis in Patients With Atherosclerosis. Circulation. 2019 Oct 29;140(18):1451-1459. doi: 10.1161/CIRCULATIONAHA.119.041949. Epub 2019 Sep 12.
PMID: 31510769RESULTPerera KS, Ng KKH, Nayar S, Catanese L, Dyal L, Sharma M, Connolly SJ, Yusuf S, Bosch J, Eikelboom JW, Hart RG. Association Between Low-Dose Rivaroxaban With or Without Aspirin and Ischemic Stroke Subtypes: A Secondary Analysis of the COMPASS Trial. JAMA Neurol. 2020 Jan 1;77(1):43-48. doi: 10.1001/jamaneurol.2019.2984.
PMID: 31524941RESULTEikelboom JW, Bosch JJ, Connolly SJ, Shestakovska O, Dagenais GR, Hart RG, Leong DP, O'Donnell M, Fox KAA, Bhatt DL, Cairns JA, Tasto C, Berkowitz SD, Cook Bruns N, Muehlhofer E, Diaz R, Maggioni AP, Yusuf S. Major Bleeding in Patients With Coronary or Peripheral Artery Disease Treated With Rivaroxaban Plus Aspirin. J Am Coll Cardiol. 2019 Sep 24;74(12):1519-1528. doi: 10.1016/j.jacc.2019.07.065.
PMID: 31537259RESULTWurtz M, Olesen KKW, Thim T, Kristensen SD, Eikelboom JW, Maeng M. External applicability of the COMPASS trial: the Western Denmark Heart Registry. Eur Heart J Cardiovasc Pharmacother. 2019 Oct 1;5(4):192-199. doi: 10.1093/ehjcvp/pvz013.
PMID: 30916315RESULTVanassche T, Verhamme P, Anand SS, Shestakovska O, Fox KA, Bhatt DL, Avezum A, Alings M, Aboyans V, Maggioni AP, Widimsky P, Berkowitz SD, Yusuf S, Connolly SJ, Eikelboom JW, Bosch J. Risk factors and clinical outcomes in chronic coronary and peripheral artery disease: An analysis of the randomized, double-blind COMPASS trial. Eur J Prev Cardiol. 2020 Feb;27(3):296-307. doi: 10.1177/2047487319882154. Epub 2019 Oct 15.
PMID: 31615291RESULTCowie MR, Lamy A, Levy P, Mealing S, Millier A, Mernagh P, Cristeau O, Bowrin K, Briere JB. Health economic evaluation of rivaroxaban in the treatment of patients with chronic coronary artery disease or peripheral artery disease. Cardiovasc Res. 2020 Sep 1;116(11):1918-1924. doi: 10.1093/cvr/cvz278.
PMID: 31807773RESULTWelsh RC, Peterson ED, De Caterina R, Bode C, Gersh B, Eikelboom JW. Applying contemporary antithrombotic therapy in the secondary prevention of chronic atherosclerotic cardiovascular disease. Am Heart J. 2019 Dec;218:100-109. doi: 10.1016/j.ahj.2019.09.006. Epub 2019 Oct 23.
PMID: 31715433RESULTSchiele F, Puymirat E, Ferrieres J, Simon T, Fox KAA, Eikelboom J, Danchin N; FAST-MI investigators. The FAST-MI 2005-2010-2015 registries in the light of the COMPASS trial: The COMPASS criteria applied to a post-MI population. Int J Cardiol. 2019 Mar 1;278:7-13. doi: 10.1016/j.ijcard.2018.11.138. Epub 2018 Dec 3.
PMID: 30538057RESULTBainey KR, Welsh RC, Connolly SJ, Marsden T, Bosch J, Fox KAA, Steg PG, Vinereanu D, Connolly DL, Berkowitz SD, Foody JM, Probstfield JL, Branch KR, Lewis BS, Diaz R, Muehlhofer E, Widimsky P, Yusuf S, Eikelboom JW, Bhatt DL; COMPASS Investigators. Rivaroxaban Plus Aspirin Versus Aspirin Alone in Patients With Prior Percutaneous Coronary Intervention (COMPASS-PCI). Circulation. 2020 Apr 7;141(14):1141-1151. doi: 10.1161/CIRCULATIONAHA.119.044598. Epub 2020 Mar 17.
PMID: 32178526RESULTLiang Y, Zhu J, Liu L, Anand SS, Connolly SJ, Bosch J, Guzik TJ, O'Donnell M, Dagenais GR, Fox KA, Shestakovska O, Berkowitz SD, Muehlhofer E, Keller L, Yusuf S, Eikelboom JW; COMPASS Investigators. Efficacy and safety of rivaroxaban plus aspirin in women and men with chronic coronary or peripheral artery disease. Cardiovasc Res. 2021 Feb 22;117(3):942-949. doi: 10.1093/cvr/cvaa100.
PMID: 32289159RESULTBhatt DL, Eikelboom JW, Connolly SJ, Steg PG, Anand SS, Verma S, Branch KRH, Probstfield J, Bosch J, Shestakovska O, Szarek M, Maggioni AP, Widimsky P, Avezum A, Diaz R, Lewis BS, Berkowitz SD, Fox KAA, Ryden L, Yusuf S; COMPASS Steering Committee and Investigators. Role of Combination Antiplatelet and Anticoagulation Therapy in Diabetes Mellitus and Cardiovascular Disease: Insights From the COMPASS Trial. Circulation. 2020 Jun 9;141(23):1841-1854. doi: 10.1161/CIRCULATIONAHA.120.046448. Epub 2020 Mar 28.
PMID: 32223318RESULTSteffel J, Eikelboom JW, Anand SS, Shestakovska O, Yusuf S, Fox KAA. The COMPASS Trial: Net Clinical Benefit of Low-Dose Rivaroxaban Plus Aspirin as Compared With Aspirin in Patients With Chronic Vascular Disease. Circulation. 2020 Jul 7;142(1):40-48. doi: 10.1161/CIRCULATIONAHA.120.046048. Epub 2020 May 21.
PMID: 32436455RESULTSharma M, Hart RG, Smith EE, Bosch J, Eikelboom JW, Connolly SJ, Dyal L, Reeh KW, Casanova A, Diaz R, Lopez-Jaramillo P, Ertl G, Stork S, Dagenais GR, Lonn EM, Ryden L, Tonkin AM, Varigos JD, Bhatt DL, Branch KRH, Probstfield JL, Kim JH, O'Donnell M, Vinereanu D, A A Fox K, Liang Y, Liu L, Zhu J, Pogosova N, Maggioni AP, Avezum A, Piegas LS, Keltai K, Keltai M, Berkowitz SD, Yusuf S. Rivaroxaban for Prevention of Covert Brain Infarcts and Cognitive Decline: The COMPASS MRI Substudy. Stroke. 2020 Oct;51(10):2901-2909. doi: 10.1161/STROKEAHA.120.029762. Epub 2020 Sep 21.
PMID: 32951537RESULTKaplovitch E, Eikelboom JW, Dyal L, Aboyans V, Abola MT, Verhamme P, Avezum A, Fox KAA, Berkowitz SD, Bangdiwala SI, Yusuf S, Anand SS. Rivaroxaban and Aspirin in Patients With Symptomatic Lower Extremity Peripheral Artery Disease: A Subanalysis of the COMPASS Randomized Clinical Trial. JAMA Cardiol. 2021 Jan 1;6(1):21-29. doi: 10.1001/jamacardio.2020.4390.
PMID: 32997098RESULTGuzik TJ, Ramasundarahettige C, Pogosova N, Lopez-Jaramillo P, Dyal L, Berkowitz SD, Muehlhofer E, Bhatt DL, Fox KAA, Yusuf S, Eikelboom JW. Rivaroxaban Plus Aspirin in Obese and Overweight Patients With Vascular Disease in the COMPASS Trial. J Am Coll Cardiol. 2021 Feb 9;77(5):511-525. doi: 10.1016/j.jacc.2020.11.061.
PMID: 33538248RESULTSen J, Tonkin A, Varigos J, Fonguh S, Berkowitz SD, Yusuf S, Verhamme P, Vanassche T, Anand SS, Fox KAA, Eikelboom JW, Amerena J; COMPASS Trial Investigators. Risk stratification of cardiovascular complications using CHA2DS2-VASc and CHADS2 scores in chronic atherosclerotic cardiovascular disease. Int J Cardiol. 2021 Aug 15;337:9-15. doi: 10.1016/j.ijcard.2021.04.067. Epub 2021 May 3.
PMID: 33957178RESULTDagenais GR, Dyal L, Bosch JJ, Leong DP, Aboyans V, Berkowitz SD, Bhatt DL, Connolly SJ, Fox KAA, Muehlhofer E, Probstfield JL, Widimsky P, Winkelmann BR, Yusuf S, Eikelboom JW. Cardiovascular consequences of discontinuing low-dose rivaroxaban in people with chronic coronary or peripheral artery disease. Heart. 2021 Jul;107(14):1130-1137. doi: 10.1136/heartjnl-2020-318758. Epub 2021 May 21.
PMID: 34021038RESULTLamy A, Browne A, Sheth T, Zheng Z, Dagenais F, Noiseux N, Chen X, Bakaeen FG, Brtko M, Stevens LM, Alboom M, Lee SF, Copland I, Salim Y, Eikelboom J; COMPASS Investigators. Skeletonized vs Pedicled Internal Mammary Artery Graft Harvesting in Coronary Artery Bypass Surgery: A Post Hoc Analysis From the COMPASS Trial. JAMA Cardiol. 2021 Sep 1;6(9):1042-1049. doi: 10.1001/jamacardio.2021.1686.
PMID: 34132753RESULTVanassche T, Verhamme P, Anand SS, Shestakovska O, Leong DP, Fox KAA, Bhatt DL, Avezum A, Alings M, Aboyans V, Maggioni AP, Widimsky P, Muehlhofer E, Berkowitz SD, Yusuf S, Connolly SJ, Eikelboom JW, Bosch J. Low-dose rivaroxaban plus aspirin in patients with polypharmacy and multimorbidity: an analysis from the COMPASS trial. Eur Heart J Cardiovasc Pharmacother. 2022 Aug 11;8(5):462-473. doi: 10.1093/ehjcvp/pvab050.
PMID: 34191011RESULTEikelboom JW, Bhatt DL, Fox KAA, Bosch J, Connolly SJ, Anand SS, Avezum A, Berkowitz SD, Branch KRH, Dagenais GR, Felix C, Guzik TJ, Hart RG, Maggioni AP, Muehlhofer E, Sharma M, Shestakovska O, Yusuf S. Mortality Benefit of Rivaroxaban Plus Aspirin in Patients With Chronic Coronary or Peripheral Artery Disease. J Am Coll Cardiol. 2021 Jul 6;78(1):14-23. doi: 10.1016/j.jacc.2021.04.083.
PMID: 34210409RESULTAnand SS, Hiatt W, Dyal L, Bauersachs R, Berkowitz SD, Branch KRH, Debus S, Fox KAA, Liang Y, Muehlhofer E, Nehler M, Haskell LP, Patel M, Szarek M, Yusuf S, Eikelboom J, Bonaca MP. Low-dose rivaroxaban and aspirin among patients with peripheral artery disease: a meta-analysis of the COMPASS and VOYAGER trials. Eur J Prev Cardiol. 2022 May 5;29(5):e181-e189. doi: 10.1093/eurjpc/zwab128.
PMID: 34463737RESULTKaplovitch E, Anand SS. The evolving treatment of peripheral arterial disease: preventing ischaemic events in the post-COMPASS era. Cardiovasc Res. 2019 Oct 1;115(12):e121-e124. doi: 10.1093/cvr/cvz170. No abstract available.
PMID: 31321405RESULTLee SF, Ramasundarahettige C, Gerstein HC, McIntyre WF, Eikelboom J, O'Donnell MJ, Zhou Y, Bangdiwala SI, Thabane L. Comparison of total event analysis and first event analysis in relation to heterogeneity in cardiovascular trials. BMC Med Res Methodol. 2025 Jun 9;25(1):159. doi: 10.1186/s12874-025-02593-3.
PMID: 40490702DERIVEDXie F, Yan J, Eikelboom J, Anand S, Muehlhofer E, Pullenayegum E, Wang Y, Avezum A, Bhatt DL, Yusuf S, Bosch J. Health-related quality of life with rivaroxaban plus aspirin vs. aspirin alone in chronic stable cardiovascular disease: Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial. Eur Heart J Open. 2024 Sep 27;4(5):oeae083. doi: 10.1093/ehjopen/oeae083. eCollection 2024 Sep.
PMID: 39439530DERIVEDEikelboom JW, Yi Q, McIntyre WF, Bosch J, Whitlock R, Connolly SJ, Scheier TC, Muehlhofer E, Pap AF, Pocock SJ, Bangdiwala SI. Results of the COMPASS Trial Analyzed Using Win Ratio Compared With Conventional Analytic Approaches. Can J Cardiol. 2024 Nov;40(11):2171-2179. doi: 10.1016/j.cjca.2024.07.002. Epub 2024 Jul 14.
PMID: 39002945DERIVEDLeong DP, Bosch J, Bhatt DL, Avezum A, Yuan F, Yusuf S, Eikelboom JW. Impact of Frailty on the Benefits of Dual Pathway Inhibition for the Secondary Prevention of Cardiovascular Events in the COMPASS Randomised Trial. Can J Cardiol. 2025 Jan;41(1):102-111. doi: 10.1016/j.cjca.2024.06.017. Epub 2024 Jun 22.
PMID: 38914270DERIVEDPyne L, Smyth A, Molnar AO, Moayyedi P, Muehlhofer E, Yusuf S, Eikelboom J, Bosch J, Walsh M. The Effects of Pantoprazole on Kidney Outcomes: Post Hoc Observational Analysis from the COMPASS Trial. J Am Soc Nephrol. 2024 Jul 1;35(7):901-909. doi: 10.1681/ASN.0000000000000356. Epub 2024 Apr 11.
PMID: 38602780DERIVEDLamy A, Eikelboom J, Tong W, Yuan F, Bangdiwala SI, Bosch J, Connolly S, Lonn E, Dagenais GR, Branch KRH, Wang WJ, Bhatt DL, Probstfield J, Ertl G, Stork S, Steg PG, Aboyans V, Durand-Zaleski I, Ryden L, Yusuf S; COMPASS Investigators. The Cost-Effectiveness of Rivaroxaban Plus Aspirin Compared with Aspirin Alone in the COMPASS Trial: A US Perspective. Am J Cardiovasc Drugs. 2024 Jan;24(1):117-127. doi: 10.1007/s40256-023-00620-6. Epub 2023 Dec 28.
PMID: 38153624DERIVEDClezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.
PMID: 37565307DERIVEDBranch KRH, Probstfield JL, Bosch J, Bhatt DL, Maggioni AP, Muehlhofer E, Avezum A, Widimsky P, Connolly SJ, Yi Q, Shestakovska O, Yusuf S, Eikelboom JW. Total events and net clinical benefit of rivaroxaban and aspirin in patients with chronic coronary or peripheral artery disease: The COMPASS trial. Am Heart J. 2023 Apr;258:60-68. doi: 10.1016/j.ahj.2023.01.008. Epub 2023 Jan 14.
PMID: 36646196DERIVEDSmolderen KG, Mena-Hurtado C, Eikelboom JW, Bosch J, Xie F, Ramasundarahettige C, Bhatt DL, Anand SS. Health status and cognitive function for risk stratification in chronic coronary and peripheral artery disease. Eur J Prev Cardiol. 2023 May 9;30(7):535-545. doi: 10.1093/eurjpc/zwac282.
PMID: 36444513DERIVEDGaba P, Bhatt DL, Dagenais GR, Bosch J, Maggioni AP, Widimsky P, Leong D, Fox KAA, Yusuf S, Eikelboom JW; COMPASS Steering Committee and Investigators. Comparison of Investigator-Reported vs Centrally Adjudicated Major Adverse Cardiac Events: A Secondary Analysis of the COMPASS Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2243201. doi: 10.1001/jamanetworkopen.2022.43201.
PMID: 36409491DERIVEDLamy A, Eikelboom J, Tong W, Yuan F, Bangdiwala SI, Bosch J, Connolly S, Lonn E, Dagenais GR, Branch KRH, Wang WJ, Bhatt DL, Probstfield J, Ertl G, Stork S, Steg PG, Aboyans V, Durand-Zaleski I, Ryden L, Yusuf S. The cost-effectiveness of rivaroxaban with or without aspirin in the COMPASS trial. Eur Heart J Qual Care Clin Outcomes. 2023 Aug 7;9(5):502-510. doi: 10.1093/ehjqcco/qcac054.
PMID: 36001989DERIVEDAlboom M, Browne A, Sheth T, Zheng Z, Dagenais F, Noiseux N, Brtko M, Stevens LM, Lee SF, Copland I, Power P, Eikelboom J, Lamy A. Conduit selection and early graft failure in coronary artery bypass surgery: A post hoc analysis of the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) coronary artery bypass grafting study. J Thorac Cardiovasc Surg. 2023 Mar;165(3):1080-1089.e1. doi: 10.1016/j.jtcvs.2022.05.028. Epub 2022 Jun 2.
PMID: 35760616DERIVEDCatanese L, Eikelboom JW, Bosch J, Shestakovska O, Ng K, Nayar S, Perera KS, Shoamanesh A, Sharma M, Hart RG. Oral factor Xa inhibitors and risk of subdural hematoma: COMPASS trial results and meta-analysis. Neurology. 2020 Aug 4;95(5):e480-e487. doi: 10.1212/WNL.0000000000009826. Epub 2020 Jul 10.
PMID: 32651298DERIVEDAnand SS, Bosch J, Eikelboom JW, Connolly SJ, Diaz R, Widimsky P, Aboyans V, Alings M, Kakkar AK, Keltai K, Maggioni AP, Lewis BS, Stork S, Zhu J, Lopez-Jaramillo P, O'Donnell M, Commerford PJ, Vinereanu D, Pogosova N, Ryden L, Fox KAA, Bhatt DL, Misselwitz F, Varigos JD, Vanassche T, Avezum AA, Chen E, Branch K, Leong DP, Bangdiwala SI, Hart RG, Yusuf S; COMPASS Investigators. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2018 Jan 20;391(10117):219-229. doi: 10.1016/S0140-6736(17)32409-1. Epub 2017 Nov 10.
PMID: 29132880DERIVEDConnolly SJ, Eikelboom JW, Bosch J, Dagenais G, Dyal L, Lanas F, Metsarinne K, O'Donnell M, Dans AL, Ha JW, Parkhomenko AN, Avezum AA, Lonn E, Lisheng L, Torp-Pedersen C, Widimsky P, Maggioni AP, Felix C, Keltai K, Hori M, Yusoff K, Guzik TJ, Bhatt DL, Branch KRH, Cook Bruns N, Berkowitz SD, Anand SS, Varigos JD, Fox KAA, Yusuf S; COMPASS investigators. Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2018 Jan 20;391(10117):205-218. doi: 10.1016/S0140-6736(17)32458-3. Epub 2017 Nov 10.
PMID: 29132879DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
One participant that was included in the Safety Analysis Set in the disclosure after primary completion never took any study drug therefore was corrected in the later analysis.
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
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
- Masking Details
- Participants who consented to COMPASS long-term open-label extension (LTOLE) part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part and no blinding procedures were applicable to the LTOLE part.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2013
First Posted
January 28, 2013
Study Start
February 28, 2013
Primary Completion
July 21, 2017
Study Completion
June 15, 2021
Last Updated
November 28, 2022
Results First Posted
October 5, 2018
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.