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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 4, 2014
Last verified: September 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, revascularization, 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: 21400
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

Patients with coronary artery disease must also meet at least one of the following:

  • Age ≥65, or
  • Age <65 and documented atherosclerosis or revascularization involving at least 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Recruiting
Santa Rosa, California, United States, 95494
Recruiting
Sylmar, California, United States, 91342
United States, Connecticut
Recruiting
Norwalk, Connecticut, United States, 06851
Recruiting
Stamford, Connecticut, United States, 06905
Recruiting
Trumbull, Connecticut, United States, 06611
United States, Florida
Not yet recruiting
Atlantis, Florida, United States, 33462
Recruiting
Clearwater, Florida, United States, 33756
Recruiting
Coral Springs, Florida, United States, 33065
Recruiting
Jacksonville Beach, Florida, United States, 32207
Recruiting
Largo, Florida, United States, 33770
Recruiting
New Port Richey, Florida, United States, 34653
Recruiting
Safety Harbor, Florida, United States, 34695
Recruiting
Sarasota, Florida, United States, 34233
United States, Idaho
Recruiting
Meridian, Idaho, United States, 83716
United States, Illinois
Recruiting
Hazel Crest, Illinois, United States, 60429
United States, Iowa
Not yet recruiting
Davenport, Iowa, United States, 52803
Recruiting
West Des Moines, Iowa, United States, 50266
United States, Maryland
Not yet recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Not yet recruiting
Haverhill, Massachusetts, United States, 01830
United States, Michigan
Recruiting
Alpena, Michigan, United States, 49707
Not yet recruiting
Petoskey, Michigan, United States, 49770-2297
United States, Missouri
Recruiting
St. Louis, Missouri, United States, 63136
United States, Montana
Recruiting
Kalispell, Montana, United States, 59901
United States, New Jersey
Not yet recruiting
New Brunswick, New Jersey, United States, 08901
United States, New York
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Cortlandt Manor, New York, United States, 10567
Recruiting
Kingston, New York, United States, 12401
Recruiting
Saratoga Springs, New York, United States, 12866
United States, North Carolina
Not yet recruiting
Durham, North Carolina, United States, 27710
Recruiting
Pinehurst, North Carolina, United States, 28374
United States, Ohio
Recruiting
Sandusky, Ohio, United States, 44870
United States, Pennsylvania
Recruiting
Langhorne, Pennsylvania, United States, 19047
Recruiting
Yardley, Pennsylvania, United States, 19067
United States, South Dakota
Not yet recruiting
Sioux Falls, South Dakota, United States, 57108
United States, Texas
Not yet recruiting
Houston, Texas, United States, 77030-4298
Recruiting
San Antonio, Texas, United States, 78229
United States, Washington
Recruiting
Puyallup, Washington, United States, 98372
Recruiting
Seattle, Washington, United States, 98195
Recruiting
Spokane, Washington, United States, 99204
Argentina
Recruiting
Adrogue, Buenos Aires, Argentina, 1846
Recruiting
Bahía Blanca, Buenos Aires, Argentina, 8000
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Coronel Suarez, Buenos Aires, Argentina, B7540GHD
Recruiting
Junín, Buenos Aires, Argentina, B6000BHA
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La Plata, Buenos Aires, Argentina, 1900
Recruiting
La Plata, Buenos Aires, Argentina, B1902AGY
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Mar del Plata, Buenos Aires, Argentina, B7600FZN
Recruiting
Quilmes, Buenos Aires, Argentina, 1878
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Ramos Mejía, Buenos Aires, Argentina, B1740ETD
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San Martín, Buenos Aires, Argentina, 1650
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San Nicolás, Buenos Aires, Argentina, B2900DMH
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Zárate, Buenos Aires, Argentina, B2800DGH
Recruiting
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1119ACN
Recruiting
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1428DCO
Recruiting
Villa Allende, Córdoba, Argentina
Recruiting
Villa María, Córdoba, Argentina, X5900JKA
Recruiting
Santa Rosa, La Pampa, Argentina, 6300
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Rafaela, Santa Fe, Argentina, S2300MMA
Recruiting
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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Corrientes, Argentina, 3400
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Córdoba, Argentina, X5000AAW Córdoba
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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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San luis, Argentina
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Santa Fe, Argentina, 3000
Brazil
Recruiting
Goiania, Goiás, Brazil, 74223 130
Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30150-240
Not yet recruiting
Uberlândia, Minas Gerais, Brazil, 38400 368
Recruiting
Campina Grande do Sul, Parana, Brazil, 83430 000
Recruiting
Curitiba, Parana, Brazil, 80730-150
Not yet recruiting
Canoas, Rio Grande do Sul, Brazil, 92425-900
Recruiting
Pelotas, Rio Grande do Sul, Brazil, 96015290
Not yet recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Not yet recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90470 340
Not yet recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90.620-001
Recruiting
Blumenau, Santa Catarina, Brazil, 89010 500
Recruiting
Campinas, Sao Paulo, Brazil, 13010-001
Not yet recruiting
Campinas, Sao Paulo, Brazil, 13060904
Not yet recruiting
Campinas, Sao Paulo, Brazil, 13020-421
Not yet recruiting
Matão, Sao Paulo, Brazil, 15990-060
Not yet recruiting
São José do Rio Preto, Sao Paulo, Brazil, 15090
Not yet recruiting
São José do Rio Preto, Sao Paulo, Brazil, 15.015.205
Recruiting
Votuporanga, Sao Paulo, Brazil
Not yet recruiting
Sao Paulo, Brazil, 05403-000
Not yet recruiting
Sao Paulo, Brazil, 05403-900
Canada, Alberta
Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
Recruiting
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
Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, New Brunswick
Recruiting
Moncton, New Brunswick, Canada, E1G 1A7
Canada, Ontario
Recruiting
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
Recruiting
Cambridge, Ontario, Canada, N1R 7R1
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Grimsby, Ontario, Canada, L3M 1P3
Recruiting
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
Recruiting
Peterborough, Ontario, Canada, K9J 0B2
Recruiting
Scarborough, Ontario, Canada, M1E 5E9
Recruiting
Sudbury, Ontario, Canada, P3E 1H5
Not yet recruiting
Toronto, Ontario, Canada, M9C 4Z5
Recruiting
Windsor, Ontario, Canada, N8X 5A6
Canada, Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
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Lachenaie, Quebec, Canada, J6V 2H2
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Laval, Quebec, Canada, H7M 3L9
Recruiting
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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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
Recruiting
Temuco, Araucanía, Chile, 2170000
Recruiting
Temuco, Araucanía, Chile, 4791348
Recruiting
Concepción, Bío-Bío, Chile, 4070038
China
Recruiting
Beijing, China, 100088
Colombia
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Barranquilla, Atlántico, 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
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Cali, Valle del Cauca, Colombia
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Barranquilla, Colombia
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Santafe de Bogotá, Colombia
Czech Republic
Recruiting
Brno, Czech Republic, 62500
Recruiting
Brno, Czech Republic, 656 91
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Cesky Krumlov, Czech Republic, 381 27
Recruiting
Hradec Kralove, Czech Republic, 500 05
Recruiting
Jablonec nad Nisou, Czech Republic, 466 60
Recruiting
Kolin, Czech Republic, 280 02
Recruiting
Ostrava, Czech Republic, 728 80
Recruiting
Ostrava, Czech Republic, 708 52
Recruiting
Praha 10, Czech Republic, 100 34
Recruiting
Praha 4, Czech Republic, 140 21
Recruiting
Praha 5, Czech Republic, 150 30
Recruiting
Praha 6, Czech Republic, 169 02
Recruiting
Slany, Czech Republic, 274 51
Recruiting
Susice, Czech Republic, 342 01
Recruiting
Trebic, Czech Republic, 674 01
Finland
Recruiting
Kuopio, Finland, 70100
Recruiting
Kuusankoski, Finland, 45700
Recruiting
Vantaa, Finland, 01600
France
Recruiting
Limoges Cedex, France, 87042
Recruiting
Paris, France, 75018
Recruiting
Paris, France, 75012
Recruiting
Paris Cedex 15, France, 75908
Germany
Recruiting
Nürnberg, Bayern, Germany, 90402
Recruiting
Würzburg, Bayern, Germany, 97078
Recruiting
Frankfurt, Hessen, Germany, 60594
Recruiting
Frankfurt, Hessen, Germany, 65929
Recruiting
Bielefeld, Nordrhein-Westfalen, Germany, 33604
Recruiting
Dortmund, Nordrhein-Westfalen, Germany, 44137
Recruiting
Magdeburg, Sachsen-Anhalt, Germany, 39112
Recruiting
Berlin, Germany, 13353
Recruiting
Berlin, Germany, 12559
Recruiting
Hamburg, Germany, 22559
Recruiting
Kassel, Germany, 34128
Recruiting
Warendorf, Germany, 48231
Hungary
Recruiting
Balatonfured, Hungary, 8230
Recruiting
Budapest, Hungary, H-1125
Recruiting
Budapest, Hungary, 1085
Recruiting
Budapest, Hungary, H-1096
Recruiting
Debrecen, Hungary, 4032
Recruiting
Mosonmagyarovar, Hungary, 9200
Recruiting
Pecs, Hungary, 7624
Recruiting
Sopron, Hungary, 9400
Recruiting
Szekesfehervar, Hungary, 8000
Recruiting
Szekszard, Hungary, 7100
Ireland
Recruiting
Ballinasloe, Co. Galway, Ireland
Recruiting
Cork, Ireland
Recruiting
Dublin, Ireland, DUBLIN 7
Recruiting
Dublin, Ireland, 8
Recruiting
Dublin, Ireland, 9
Recruiting
Galway, Ireland
Israel
Recruiting
Afula, Israel, 1834111
Recruiting
Ashkelon, Israel, 7830604
Recruiting
Givataim, Israel
Recruiting
Haifa, Israel, 3109601
Recruiting
Haifa, Israel, 34362
Recruiting
Holon, Israel, 58100
Recruiting
Nahariya, Israel, 22100
Recruiting
Safed, Israel, 1311001
Recruiting
Tel Aviv, Israel, 64239
Recruiting
Tel Aviv, Israel
Italy
Recruiting
Cortona, Arezzo, Italy, 52040
Recruiting
San Felice a Cancello, Caserta, Italy, 81027
Recruiting
Empoli, Firenze, Italy, 50053
Recruiting
Casarano, Lecce, Italy, 73042
Recruiting
Gubbio, Perugia, Italy, 06024
Recruiting
Palmanova, Udine, Italy, 33057
Recruiting
San Daniele del Friuli, Udine, Italy, 33038
Recruiting
Ancona, Italy, 60126
Not yet recruiting
Bologna, Italy, 40133
Recruiting
Catania, Italy, 95126
Recruiting
Cremona, Italy, 26100
Recruiting
Foggia, Italy, 71100
Recruiting
Forlì, Italy, 47100
Recruiting
Isernia, Italy, 86170
Recruiting
Palermo, Italy, 90146
Not yet recruiting
Pavia, Italy, 27100
Recruiting
Terni, Italy, 05100
Recruiting
Trieste, Italy, 34149
Recruiting
Udine, Italy, 33100
Japan
Recruiting
Nagoya, Aichi, Japan, 453-8511
Recruiting
Toyoake, Aichi, Japan, 470-1192
Recruiting
Kisarazu, Chiba, Japan, 292-8535
Recruiting
Matsudo, Chiba, Japan, 270-2251
Recruiting
Kasuga, Fukuoka, Japan, 816-0864
Not yet recruiting
Onomichi, Hiroshima, Japan, 722-8503
Recruiting
Asahikawa, Hokkaido, Japan, 070-0038
Recruiting
Asahikawa, Hokkaido, Japan, 070-8610
Recruiting
Sapporo, Hokkaido, Japan, 060-0001
Recruiting
Spporo, Hokkaido, Japan, 006-0852
Recruiting
Kobe, Hyogo, Japan, 654-0026
Recruiting
Miura-gun, Kanagawa, Japan, 240-0116
Recruiting
Yokohama, Kanagawa, Japan, 232-0024
Recruiting
Naha, Okinawa, Japan, 902-8511
Recruiting
Kishiwada, Osaka, Japan, 596-8522
Recruiting
Tokorozawa, Saitama, Japan, 359-1141
Recruiting
Komatsushima, Tokushima, Japan, 773-8502
Recruiting
Akishima, Tokyo, Japan, 196-0003
Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8431
Recruiting
Itabashi-ku, Tokyo, Japan, 173-8610
Recruiting
Shimonoseki, Yamaguchi, Japan, 750-0061
Recruiting
Chiba, Japan, 263-0043
Recruiting
Fukuoka, Japan, 814-0180
Recruiting
Fukuoka, Japan, 812-0033
Recruiting
Gifu, Japan, 500-8717
Recruiting
Kyoto, Japan, 600-8558
Terminated
Nagasaki, Japan, 850-8555
Recruiting
Osaka, Japan, 530-8480
Recruiting
Osaka, Japan, 530-0001
Recruiting
Osaka, Japan, 543-0035
Recruiting
Osaka, Japan, 558-8558
Terminated
Osaka, Japan, 530-0001
Korea, Republic of
Recruiting
Wonju-si, Gang''weondo, Korea, Republic of, 220-701
Recruiting
Goyang-si, Gyeonggido, Korea, Republic of, 410-773
Recruiting
Jeju, Jejudo, Korea, Republic of, 690767
Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 150-713
Recruiting
Busan, Korea, Republic of, 614-735
Recruiting
Daejeon, Korea, Republic of, 302-718
Not yet recruiting
Seoul, Korea, Republic of, 134-727
Malaysia
Recruiting
Alor Setar,, Malaysia, 05460
Recruiting
Batu Caves, Selangor, Malaysia, 68100
Recruiting
Kuala Lumpur, Malaysia, 59100
Recruiting
Sungai Buloh Selangor, Malaysia, 47000
Netherlands
Recruiting
Amsterdam, Netherlands, 1091 AC
Recruiting
Arnhem, Netherlands, 6815 AD
Recruiting
Breda, Netherlands, 4818 CK
Recruiting
Delft, Netherlands, 2625 AD
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Den Bosch, Netherlands, 5223 GZ
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Deventer, Netherlands, 7416 SE
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Gorinchem, Netherlands, 4204 AA
Recruiting
Gouda, Netherlands, 2803 HH
Recruiting
Heerlen, Netherlands, 6401 CX
Recruiting
Helmond, Netherlands, 5707 HA
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Hoogeveen, Netherlands, 7909 AA
Recruiting
Leeuwarden, Netherlands, 8901 BR
Recruiting
Meppel, Netherlands, 7943 KA
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
Recruiting
Tiel, Netherlands, 4002 WP
Recruiting
Zwolle, Netherlands, 8011 JW
Philippines
Recruiting
Cebu City, Philippines, 6000
Recruiting
Dasmarinas, Philippines, 4114
Recruiting
Iloilo City, Philippines, 5000
Recruiting
Manila, Philippines, 1000
Recruiting
Manila, Philippines
Recruiting
Metro Manila, Philippines, 1502
Recruiting
Palawan, Philippines, 5300
Recruiting
Pasig city, Philippines, 1605
Recruiting
Quezon City, Philippines, 1109
Recruiting
Quezon City, Philippines, 1102
Recruiting
Quezon City, Philippines
Poland
Recruiting
Gdansk, Poland, 80-126
South Africa
Recruiting
Pinelands, Eastern Cape, South Africa, 7503
Recruiting
Port Elizabeth, Eastern Cape, South Africa, 6014
Recruiting
Bloemfontein, Freestate, South Africa, 9300
Recruiting
Cape Town, Western Cape, South Africa, 7531
Recruiting
Observatory, Western Cape, South Africa, 7925
Recruiting
Pinelands, Western Cape, South Africa, 7405
Recruiting
Worcester, Western Cape, South Africa, 6850
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, 171 76
Recruiting
Stockholm, Sweden, 111 35
Recruiting
Stockholm, Sweden, 141 86
Recruiting
Stockholm, Sweden, 111 57
Recruiting
Vällingby, Sweden, 162 68
Recruiting
Örebro, Sweden, 701 85
Recruiting
Östersund, Sweden, 831 83
Switzerland
Recruiting
Lugano, Ticino, Switzerland, 6900
Ukraine
Not yet recruiting
Donetsk, Ukraine, 83114
Recruiting
Kharkiv, Ukraine, 61002
Recruiting
Kharkiv, Ukraine, 61039
Recruiting
Kharkiv, Ukraine, 61176
Recruiting
Kiev, Ukraine, 03 049
Recruiting
Kiev, Ukraine, 02660
Recruiting
Lviv, Ukraine, 79659
Recruiting
Simferopol, Ukraine, 95006
Recruiting
Zaporozhye, Ukraine, 69118
United Kingdom
Recruiting
Belfast, Antrim, United Kingdom, BT16 1RH
Recruiting
Londonderry Co. Londonderry, Derry, United Kingdom, BT47 6SB
Recruiting
Basildon, Essex, United Kingdom, SS16 5NL
Recruiting
Blackpool, Lancashire, United Kingdom, FY4 3AD
Recruiting
Harrow, London, United Kingdom, HA1 3UJ
Recruiting
Portadown, North Ireland, United Kingdom
Recruiting
Hardwick, Stockton-on-Tees, United Kingdom, TS29 6NH
Recruiting
Nuneaton, Warwickshire, United Kingdom, CV10 7DJ
Recruiting
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
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: September 4, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: National Health Surveillance Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Denmark: Danish Health and Medicines Authority
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
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
Slovakia: The Ministry of Health of the Slovak Republic
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:
coronary disease
coronary artery bypass graft
heart attack
transient ischemic attack
heart disease
Cardiovascular events
Rivaroxaban
Xarelto
anticoagulant
blood thinner
aspirin
ASA
CAD
artery disease
stroke
angina
arterial vascular disease
TIA

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Aspirin
Pantoprazole
Rivaroxaban
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

ClinicalTrials.gov processed this record on September 15, 2014