Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease (COMPASS)

This study is currently recruiting participants.
Verified April 2014 by Bayer
Sponsor:
Collaborator:
Hamilton Health Sciences Corporation, Population Health Research Institute
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01776424
First received: January 24, 2013
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

The primary purpose of this study is to evaluate whether treatment with rivaroxaban and aspirin or rivaroxaban alone is better than aspirin alone in prevention of heart attacks, stroke or cardiovascular death in patients with coronary or peripheral artery disease.


Condition Intervention Phase
Prevention & Control
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Drug: Aspirin
Drug: Aspirin placebo
Drug: Rivaroxaban placebo
Drug: Pantoprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time from randomization to first occurrence of either myocardial infarction, stroke, cardiovascular death, venous thromboembolism or cardiovascular hospitalization [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Time from randomization to first occurrence of all-cause mortality [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 19500
Study Start Date: February 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rivaroxaban [2.5mg] + Aspirin
Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban 2.5 mg twice daily, tablet
Drug: Aspirin
Aspirin 100 mg once daily, tablet
Drug: Pantoprazole
Subjects who are not on a PPI (proton pump inhibitor) will also be randomized to pantoprazole or pantoprazole placebo
Experimental: Rivaroxaban [5mg] + Placebo(1)
Rivaroxaban 5 mg twice daily and Aspirin Placebo once daily
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban 5.0 mg twice daily, tablet
Drug: Aspirin placebo
Placebo(1), matching Aspirin tablets
Drug: Pantoprazole
Subjects who are not on a PPI (proton pump inhibitor) will also be randomized to pantoprazole or pantoprazole placebo
Active Comparator: Aspirin + Placebo(2)
Rivaroxaban Placebo twice daily and Aspirin 100 mg once daily
Drug: Aspirin
Aspirin 100 mg once daily, tablet
Drug: Rivaroxaban placebo
Placebo(2), matching Rivaroxaban tablets
Drug: Pantoprazole
Subjects who are not on a PPI (proton pump inhibitor) will also be randomized to pantoprazole or pantoprazole placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Coronary or peripheral artery disease plus at least one of the following:

    • Age ≥65
    • Age <65 plus documented atherosclerosis in at least two vascular beds or at least 2 additional risk factors

Exclusion Criteria:

  • Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy or oral anticoagulant therapy
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776424

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Hide Study Locations
Locations
United States, Alabama
Not yet recruiting
Birmingham, Alabama, United States, 35294
Recruiting
Mobile, Alabama, United States, 36608
United States, California
Recruiting
Anaheim, California, United States, 92801
Recruiting
Laguna Hills, California, United States, 92653
Recruiting
Northridge, California, United States, 91324
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Santa Rosa, California, United States, 95494
Recruiting
Sylmar, California, United States, 91342
United States, Connecticut
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Norwalk, Connecticut, United States, 06851
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Stamford, Connecticut, United States, 06905
Recruiting
Trumbull, Connecticut, United States, 06611
United States, Florida
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Atlantis, Florida, United States, 33462
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Clearwater, Florida, United States, 33756
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Coral Springs, Florida, United States, 33065
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Jacksonville Beach, Florida, United States, 32207
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Largo, Florida, United States, 33770
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New Port Richey, Florida, United States, 34653
Recruiting
Safety Harbor, Florida, United States, 34695
Recruiting
Sarasota, Florida, United States, 34233
United States, Idaho
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Meridian, Idaho, United States, 83716
United States, Illinois
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Hazel Crest, Illinois, United States, 60429
United States, Iowa
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Davenport, Iowa, United States, 52803
Recruiting
West Des Moines, Iowa, United States, 50266
United States, Maryland
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Baltimore, Maryland, United States, 21201
United States, Massachusetts
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Haverhill, Massachusetts, United States, 01830
United States, Michigan
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Alpena, Michigan, United States, 49707
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Petoskey, Michigan, United States, 49770-2297
United States, Missouri
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St. Louis, Missouri, United States, 63136
United States, Montana
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Kalispell, Montana, United States, 59901
United States, New Jersey
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New Brunswick, New Jersey, United States, 08901
United States, New York
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Cortlandt Manor, New York, United States, 10567
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Kingston, New York, United States, 12401
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Saratoga Springs, New York, United States, 12866
United States, North Carolina
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Durham, North Carolina, United States, 27710
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Pinehurst, North Carolina, United States, 28374
United States, Ohio
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Sandusky, Ohio, United States, 44870
United States, Pennsylvania
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Langhorne, Pennsylvania, United States, 19047
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Yardley, Pennsylvania, United States, 19067
United States, South Dakota
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Sioux Falls, South Dakota, United States, 57108
United States, Texas
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Houston, Texas, United States, 77030-4298
United States, Washington
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Puyallup, Washington, United States, 98372
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Seattle, Washington, United States, 98195
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Spokane, Washington, United States, 99204
Argentina
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Adrogue, Buenos Aires, Argentina, 1846
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Bahía Blanca, Buenos Aires, Argentina, 8000
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Coronel Suarez, Buenos Aires, Argentina, B7540GHD
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La Plata, Buenos Aires, Argentina, B1902AGY
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Mar del Plata, Buenos Aires, Argentina, B7600FZN
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San Martín, Buenos Aires, Argentina, 1650
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Zárate, Buenos Aires, Argentina, B2800DGH
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Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1119ACN
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Villa Allende, Córdoba, Argentina
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Santa Rosa, La Pampa, Argentina, 6300
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Rafaela, Santa Fe, Argentina, S2300MMA
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Rosario, Santa Fe, Argentina, 2000
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Venado Tuerto, Santa Fe, Argentina, S2600KUE
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San Miguel de Tucumán, Tucuman, Argentina, 4000
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Córdoba, Argentina, X5000AAX
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Salta, Argentina, A4406CLA
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San Juan, Argentina, 5400
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Santa Fe, Argentina, 3000
Brazil
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Goiania, Goiás, Brazil, 74223 130
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Belo Horizonte, Minas Gerais, Brazil, 30150-240
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Uberlândia, Minas Gerais, Brazil, 38400 368
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Campina Grande do Sul, Parana, Brazil, 83430 000
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Canoas, Rio Grande do Sul, Brazil, 92425-900
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Pelotas, Rio Grande do Sul, Brazil, 96015290
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Porto Alegre, Rio Grande do Sul, Brazil, 90470 340
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil, 90.620-001
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Blumenau, Santa Catarina, Brazil, 89010 500
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Campinas, Sao Paulo, Brazil, 13010-001
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Campinas, Sao Paulo, Brazil, 13060904
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Campinas, Sao Paulo, Brazil, 13020-421
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Matão, Sao Paulo, Brazil, 15990-060
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São José do Rio Preto, Sao Paulo, Brazil, 15090
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São José do Rio Preto, Sao Paulo, Brazil, 15.015.205
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Sao Paulo, Brazil, 05403-900
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Sao Paulo, Brazil, 05403-000
Canada, Alberta
Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
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New Westminster, British Columbia, Canada, V3L 3W4
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Victoria, British Columbia, Canada, V8R 4R2
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R2V 4W3
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Winnipeg, Manitoba, Canada, R2H 0R8
Canada, New Brunswick
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Moncton, New Brunswick, Canada, E1G 1A7
Canada, Ontario
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Brampton, Ontario, Canada, L6W 2X7
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Burlington, Ontario, Canada, L7M 4Y1
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Burlington, Ontario, Canada, L7R 1E2
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Cambridge, Ontario, Canada, N1R 6V6
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Cambridge, Ontario, Canada, N1R 7R1
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Grimsby, Ontario, Canada, L3M 1P3
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Hamilton, Ontario, Canada, L8L 2X2
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Hamilton, Ontario, Canada, L8M 1K7
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Kitchener, Ontario, Canada, N2H 5Z8
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Mississauga, Ontario, Canada, L5K 2L3
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Newmarket, Ontario, Canada, L3Y 8C3
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Newmarket, Ontario, Canada, L3Y 2P6
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Oakville, Ontario, Canada, L6K 3W7
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Oshawa, Ontario, Canada, L1J 2J9
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Oshawa, Ontario, Canada, L1J 2K1
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Ottawa, Ontario, Canada, K2H 8T5
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Peterborough, Ontario, Canada, K9J 0B2
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Scarborough, Ontario, Canada, M1E 5E9
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Sudbury, Ontario, Canada, P3E 1H5
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Toronto, Ontario, Canada, M9C 4Z5
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Windsor, Ontario, Canada, N8X 5A6
Canada, Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
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Levis, Quebec, Canada, G6V 4Z5
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Montreal, Quebec, Canada, H3G 1A4
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Montreal, Quebec, Canada, H2W 1T8
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Montreal, Quebec, Canada, H2W 1T8
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Sherbrooke, Quebec, Canada, J1H 5N4
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Thetford Mines, Quebec, Canada, G6G 2V4
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Trois-Rivieres, Quebec, Canada, G8Z 4K4
Canada
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Quebec, Canada, G1V 4G5
Chile
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Temuco, Araucanía, Chile, 2170000
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Concepción, Bío-Bío, Chile, 4070038
Colombia
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Barranquilla, Atlántico, Colombia
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Cartagena, Bolívar, Colombia
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Cartagena, Bolívar, Colombia
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Manizales, Caldas, Colombia
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Armenia, Quindío, Colombia
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Pereira, Risaralda, Colombia
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Bucaramanga, Santander, Colombia
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Espinal, Tolima, Colombia
Czech Republic
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Brno, Czech Republic, 656 91
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Hradec Kralove, Czech Republic, 500 05
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Jablonec nad Nisou, Czech Republic, 466 60
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Kolin, Czech Republic, 280 02
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Ostrava, Czech Republic, 708 52
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Praha 10, Czech Republic, 100 34
Recruiting
Praha 4, Czech Republic, 140 21
Recruiting
Praha 5, Czech Republic, 150 30
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Slany, Czech Republic, 274 51
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Susice, Czech Republic, 342 01
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Trebic, Czech Republic, 674 01
Finland
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Kuopio, Finland, 70100
France
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Paris, France, 75018
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Paris Cedex 15, France, 75908
Germany
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Nürnberg, Bayern, Germany, 90402
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Würzburg, Bayern, Germany, 97078
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Frankfurt, Hessen, Germany, 60594
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Frankfurt, Hessen, Germany, 65929
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Bielefeld, Nordrhein-Westfalen, Germany, 33604
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Dortmund, Nordrhein-Westfalen, Germany, 44137
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Magdeburg, Sachsen-Anhalt, Germany, 39112
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Berlin, Germany, 13353
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Berlin, Germany, 12559
Recruiting
Kassel, Germany, 34128
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Warendorf, Germany, 48231
Hungary
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Balatonfured, Hungary, 8230
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Budapest, Hungary, 1085
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Budapest, Hungary, H-1096
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Debrecen, Hungary, 4032
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Mosonmagyarovar, Hungary, 9200
Ireland
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Ballinasloe, Co. Galway, Ireland
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Cork, Ireland
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Dublin, Ireland, 9
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Dublin, Ireland, DUBLIN 7
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Dublin, Ireland, 8
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Galway, Ireland
Israel
Recruiting
Afula, Israel, 1834111
Recruiting
Ashkelon, Israel, 7830604
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Givataim, Israel
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Haifa, Israel, 34362
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Haifa, Israel, 3109601
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Holon, Israel, 58100
Recruiting
Nahariya, Israel, 22100
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Safed, Israel, 1311001
Recruiting
Tel Aviv, Israel
Not yet recruiting
Tel Aviv, Israel, 64239
Italy
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Cortona, Arezzo, Italy, 52040
Recruiting
San Felice a Cancello, Caserta, Italy, 81027
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Empoli, Firenze, Italy, 50053
Recruiting
Casarano, Lecce, Italy, 73042
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Gubbio, Perugia, Italy, 06024
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Palmanova, Udine, Italy, 33057
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San Daniele del Friuli, Udine, Italy, 33038
Recruiting
Ancona, Italy, 60126
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Bologna, Italy, 40133
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Catania, Italy, 95126
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Cremona, Italy, 26100
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Foggia, Italy, 71100
Recruiting
Forlì, Italy, 47100
Recruiting
Isernia, Italy, 86170
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Palermo, Italy, 90146
Not yet recruiting
Pavia, Italy, 27100
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Terni, Italy, 05100
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Trieste, Italy, 34149
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Udine, Italy, 33100
Japan
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Toyoake, Aichi, Japan, 470-1192
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Kasuga, Fukuoka, Japan, 816-0864
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Asahikawa, Hokkaido, Japan, 070-0038
Recruiting
Asahikawa, Hokkaido, Japan, 070-8610
Recruiting
Kobe, Hyogo, Japan, 654-0026
Recruiting
Yokohama, Kanagawa, Japan, 232-0024
Recruiting
Kishiwada, Osaka, Japan, 596-8522
Recruiting
Komatsushima, Tokushima, Japan, 773-8502
Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8431
Recruiting
Itabashi-ku, Tokyo, Japan, 173-8610
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Fukuoka, Japan, 814-0180
Recruiting
Gifu, Japan, 500-8717
Recruiting
Kyoto, Japan, 600-8558
Recruiting
Osaka, Japan, 530-8480
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Osaka, Japan, 543-0035
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Osaka, Japan, 558-8558
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Osaka, Japan, 530-0001
Korea, Republic of
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Jeju, Jejudo, Korea, Republic of, 690767
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Seoul, Korea, Republic of, 134-727
Malaysia
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Sungai Buloh Selangor, Malaysia, 47000
Netherlands
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Amsterdam, Netherlands, 1091 AC
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Arnhem, Netherlands, 6815 AD
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Breda, Netherlands, 4818 CK
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Delft, Netherlands, 2625 AD
Recruiting
Deventer, Netherlands, 7416 SE
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Gorinchem, Netherlands, 4204 AA
Recruiting
Gouda, Netherlands, 2803 HH
Recruiting
Heerlen, Netherlands, 6401 CX
Not yet recruiting
Helmond, Netherlands, 5707 HA
Recruiting
Hoogeveen, Netherlands, 7909 AA
Recruiting
Leeuwarden, Netherlands, 8901 BR
Recruiting
Nijmegen, Netherlands, 6532 SZ
Recruiting
Roermond, Netherlands, 6043 CV
Recruiting
Roosendaal, Netherlands, 4708 AE
Recruiting
Rotterdam, Netherlands, 3083 AN
Recruiting
Sneek, Netherlands, 8601 ZK
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Tiel, Netherlands, 4002 WP
Recruiting
Zwolle, Netherlands, 8011 JW
Philippines
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Iloilo City, Philippines, 5000
Recruiting
Manila, Philippines, 1000
Recruiting
Quezon City, Philippines, 1109
Recruiting
Quezon City, Philippines
South Africa
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Pinelands, Eastern Cape, South Africa, 7503
Recruiting
Port Elizabeth, Eastern Cape, South Africa, 6014
Not yet recruiting
Bloemfontein, Freestate, South Africa, 9300
Not yet recruiting
Cape Town, Western Cape, South Africa, 7531
Recruiting
Observatory, Western Cape, South Africa, 7925
Not yet recruiting
Worcester, Western Cape, South Africa, 6850
Not yet recruiting
Somerset West, South Africa, 7130
Sweden
Recruiting
Göteborg, Sweden, 413 45
Recruiting
Helsingborg, Sweden, 251 87
Recruiting
Kristianstad, Sweden, 291 85
Recruiting
Skellefteå, Sweden, 931 86
Recruiting
Stockholm, Sweden, 111 35
Recruiting
Stockholm, Sweden, 171 76
Recruiting
Stockholm, Sweden, 111 57
Recruiting
Stockholm, Sweden, 141 86
Recruiting
Vällingby, Sweden, 162 68
Recruiting
Örebro, Sweden, 701 85
Not yet recruiting
Östersund, Sweden, 831 83
Switzerland
Recruiting
Lugano, Ticino, Switzerland, 6900
Ukraine
Not yet recruiting
Donetsk, Ukraine, 83114
Not yet recruiting
Kharkiv, Ukraine, 61176
Recruiting
Kharkiv, Ukraine, 61002
Not yet recruiting
Kiev, Ukraine, 02660
Recruiting
Kiev, Ukraine, 03 049
Not yet recruiting
Lviv, Ukraine, 79659
Not yet recruiting
Simferopol, Ukraine, 95006
Recruiting
Zaporozhye, Ukraine, 69118
United Kingdom
Not yet recruiting
Londonderry Co. Londonderry, Derry, United Kingdom, BT47 6SB
Not yet recruiting
Basildon, Essex, United Kingdom, SS16 5NL
Not yet recruiting
Blackpool, Lancashire, United Kingdom, FY4 3AD
Not yet recruiting
Harrow, London, United Kingdom, HA1 3UJ
Recruiting
Portadown, North Ireland, United Kingdom
Not yet recruiting
Hardwick, Stockton-on-Tees, United Kingdom, TS29 6NH
Not yet recruiting
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Not yet recruiting
Worcester, Worcestershire, United Kingdom, WR5 1DD
Sponsors and Collaborators
Bayer
Hamilton Health Sciences Corporation, Population Health Research Institute
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01776424     History of Changes
Other Study ID Numbers: 15786, 2012-004180-43
Study First Received: January 24, 2013
Last Updated: April 7, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Canada: Health Canada
Chile: Instituto de Salud Publica de Chile
China: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Ecuador: Public Health Ministry
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: Scientific and Medical Research Council Ethics Committee
India: Drugs Controller General of India
Ireland: Irish Medicines Board
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Japan: Pharmaceuticals and Medical Devices Agency
Malaysia: National Pharmaceutical Control Bureau
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Philippines : Food and Drug Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
South Africa: Department of Health
South Korea: Korea Food and Drug Administration (KFDA)
Sweden: Medical Products Agency
Switzerland: Swissmedic
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Bayer:
stroke
Cardiovascular events
Rivaroxaban
Xarelto
anticoagulant
blood thinner
aspirin
ASA
CAD
coronary disease
artery disease
coronary artery bypass graft
heart attack
angina
arterial vascular disease
transient ischemic attack
TIA
heart disease

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Aspirin
Pantoprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Proton Pump Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014