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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01776424
Recruitment Status : Active, not recruiting
First Posted : January 28, 2013
Last Update Posted : June 29, 2018
Hamilton Health Sciences Corporation, Population Health Research Institute
Janssen Research & Development, LLC
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Prevention & Control Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Aspirin Drug: Aspirin placebo Drug: Rivaroxaban placebo Drug: Pantoprazole Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27395 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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).
Actual Study Start Date : February 28, 2013
Actual Primary Completion Date : July 21, 2017
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Rivaroxaban [2.5mg] + Aspirin
Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily. (Long-term open-label extension was added to make rivaroxaban 2.5 mg twice daily + aspirin 100 mg once daily available to COMPASS trial subjects until the rivaroxaban treatment is commercially available for this indication or for approximately 3 years from regulatory approval of the long term open label extension in a country, whichever comes first.)
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

Primary Outcome Measures :
  1. Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death [ Time Frame: Approximately 6 years ]
  2. Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis) [ Time Frame: Approximately 6 years ]

Secondary Outcome Measures :
  1. Time from randomization to first occurrence of either coronary heart disease death, myocardial infarction, ischemic stroke, acute limb ischemia [ Time Frame: Approximately 6 years ]
  2. Time from randomization to first occurrence of either cardiovascular death, myocardial infarction, ischemic stroke, acute limb ischemia [ Time Frame: Approximately 6 years ]
  3. Time from randomization to first occurrence of all-cause mortality [ Time Frame: Approximately 6 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01776424

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United States, Alabama
Birmingham, Alabama, United States, 35294
Mobile, Alabama, United States, 36608
United States, California
Anaheim, California, United States, 92801
Laguna Hills, California, United States, 92653
Northridge, California, United States, 91324
Palo Alto, California, United States, 94304-1207
Santa Rosa, California, United States, 95494
Sylmar, California, United States, 91342
Torrance, California, United States, 90502-2004
United States, Connecticut
Norwalk, Connecticut, United States, 06851
Stamford, Connecticut, United States, 06905
Trumbull, Connecticut, United States, 06611
United States, Florida
Atlantis, Florida, United States, 33462
Clearwater, Florida, United States, 33756
Coral Springs, Florida, United States, 33065
Jacksonville Beach, Florida, United States, 32207
Largo, Florida, United States, 33770
New Port Richey, Florida, United States, 34653
Safety Harbor, Florida, United States, 34695
Sarasota, Florida, United States, 34233
United States, Idaho
Meridian, Idaho, United States, 83716
United States, Illinois
Arlington Heights, Illinois, United States, 60005
Hazel Crest, Illinois, United States, 60429
United States, Iowa
Davenport, Iowa, United States, 52803
West Des Moines, Iowa, United States, 50266
United States, Kentucky
Crestview Hills, Kentucky, United States, 41017-5460
United States, Maryland
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Haverhill, Massachusetts, United States, 01830
United States, Michigan
Alpena, Michigan, United States, 49707
Jackson, Michigan, United States, 49201
United States, Missouri
Saint Louis, Missouri, United States, 63136
United States, Montana
Kalispell, Montana, United States, 59901
United States, New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
Cortlandt Manor, New York, United States, 10567
Kingston, New York, United States, 12401
Saratoga Springs, New York, United States, 12866
United States, North Carolina
Durham, North Carolina, United States, 27713
Pinehurst, North Carolina, United States, 28374
United States, Ohio
Elyria, Ohio, United States, 44035
Sandusky, Ohio, United States, 44870
Toledo, Ohio, United States, 43606
United States, Pennsylvania
Doylestown, Pennsylvania, United States, 18901
Langhorne, Pennsylvania, United States, 19047
Yardley, Pennsylvania, United States, 19067
United States, South Dakota
Sioux Falls, South Dakota, United States, 57108
United States, Texas
Dallas, Texas, United States, 75216-7167
Houston, Texas, United States, 77030-4298
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229
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Bellevue, Washington, United States, 98004-4623
Puyallup, Washington, United States, 98372
Seattle, Washington, United States, 98195
Spokane, Washington, United States, 99204
Adrogue, Buenos Aires, Argentina, 1846
Bahía Blanca, Buenos Aires, Argentina, 8000
Coronel Suarez, Buenos Aires, Argentina, B7540GHD
Junín, Buenos Aires, Argentina, B6000BHA
La Plata, Buenos Aires, Argentina, 1900
La Plata, Buenos Aires, Argentina, B1902AGY
La Plata, Buenos Aires, Argentina, B1902CNF
La Plata, Buenos Aires, Argentina, B1902COS
Mar del Plata, Buenos Aires, Argentina, B7600FZN
Merlo, Buenos Aires, Argentina, B1722COV
Munro, Buenos Aires, Argentina, B1605DSX
Quilmes, Buenos Aires, Argentina, 1878
Ramos Mejía, Buenos Aires, Argentina, B1740ETD
San Martín, Buenos Aires, Argentina, 1650
San Nicolás, Buenos Aires, Argentina, B2900DMH
Vicente López, Buenos Aires, Argentina, B1602ABQ
Zárate, Buenos Aires, Argentina, B2800DGH
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1119ACN
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1428DCO
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1440AAD
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Villa Allende, Córdoba, Argentina
Villa María, Córdoba, Argentina, X5900JKA
Santa Rosa, La Pampa, Argentina, 6300
Rafaela, Santa Fe, Argentina, S2300MMA
Rosario, Santa Fe, Argentina, 2000
Rosario, Santa Fe, Argentina, S2005PAF
Rosario, Santa Fe, Argentina
Venado Tuerto, Santa Fe, Argentina, S2600KUE
San Miguel de Tucumán, Tucuman, Argentina, 4000
San Miguel de Tucumán, Tucuman, Argentina, T4000IFL
Ciudad Auton. de Buenos Aires, Argentina, C1023AAB
Ciudad Auton. de Buenos Aires, Argentina, C1181ACL
Ciudad Auton. de Buenos Aires, Argentina, C1405BUB
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Córdoba, Argentina, X5000AAW Córdoba
Córdoba, Argentina, X5000AAX
Córdoba, Argentina, X5003DCE
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Córdoba, Argentina, X5004CDT
Córdoba, Argentina, X5006IKK
Salta, Argentina, A4406CLA
San Juan, Argentina, 5400
San luis, Argentina, 5700
Santa Fe, Argentina, 3000
Australia, Australian Capital Territory
Bruce, Australian Capital Territory, Australia, 2617
Australia, New South Wales
Gosford, New South Wales, Australia, 2250
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Australia, Queensland
Birtinya, Queensland, Australia, 4575
Brisbane, Queensland, Australia, 4029
Brisbane, Queensland, Australia, 4064
Redcliffe, Queensland, Australia, 4020
Woolloongabba, Queensland, Australia, 4102
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Adelaide, South Australia, Australia, 5042
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Hobart, Tasmania, Australia, 7000
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Geelong, Victoria, Australia, 3220
Melbourne, Victoria, Australia, 3052
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Murdoch, Western Australia, Australia, 6150
Nedlands, Western Australia, Australia, 6009
Taree, Australia, 2430
Antwerpen, Belgium, 2020
Bonheiden, Belgium, 2820
Brugge, Belgium, 8000
Bruxelles - Brussel, Belgium, 1070
Charleroi, Belgium, 6000
Genk, Belgium, 3600
Hasselt, Belgium, 3500
Kortrijk, Belgium, 8500
Leuven, Belgium, 3000
Liege, Belgium, 4000
Roeselare, Belgium, 8800
Goiania, Goiás, Brazil, 74223 130
Belo Horizonte, Minas Gerais, Brazil, 30150-240
Uberaba, Minas Gerais, Brazil, 38025-260
Uberlândia, Minas Gerais, Brazil, 38400 368
Campina Grande do Sul, Parana, Brazil, 83430 000
Curitiba, Parana, Brazil, 80730-150
Canoas, Rio Grande Do Sul, Brazil, 92425-900
Pelotas, Rio Grande Do Sul, Brazil, 96015290
Porto Alegre, Rio Grande Do Sul, Brazil, 90.620-001
Porto Alegre, Rio Grande Do Sul, Brazil, 90110-270
Porto Alegre, Rio Grande Do Sul, Brazil, 90470 340
Porto Alegre, Rio Grande Do Sul, Brazil
Blumenau, Santa Catarina, Brazil, 89010 500
Campinas, Sao Paulo, Brazil, 13010-001
Campinas, Sao Paulo, Brazil, 13020-421
Campinas, Sao Paulo, Brazil, 13060904
Matão, Sao Paulo, Brazil, 15990-060
São José do Rio Preto, Sao Paulo, Brazil, 15.015.205
São José do Rio Preto, Sao Paulo, Brazil, 15090
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Calgary, Alberta, Canada, T2N 4Z6
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New Westminster, British Columbia, Canada, V3L 3W4
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Winnipeg, Manitoba, Canada, R2H 0R8
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Moncton, New Brunswick, Canada, E1G 1A7
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Halifax, Nova Scotia, Canada, B3H 3A7
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Brampton, Ontario, Canada, L6W 2X7
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Cambridge, Ontario, Canada, N1R 7R1
Grimsby, Ontario, Canada, L3M 1P3
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Hamilton, Ontario, Canada, L8M 1K7
London, Ontario, Canada, N6A 5A5
London, Ontario, Canada, N6G 2M1
Mississauga, Ontario, Canada, L5K 2L3
Newmarket, Ontario, Canada, L3Y 2P6
Newmarket, Ontario, Canada, L3Y 8C3
Oakville, Ontario, Canada, L6K 3W7
Oshawa, Ontario, Canada, L1J 2J9
Oshawa, Ontario, Canada, L1J 2K1
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Scarborough, Ontario, Canada, M1E 5E9
Sudbury, Ontario, Canada, P3E 1H5
Sudbury, Ontario, Canada, P3E 6C3
Toronto, Ontario, Canada, M4N 3M5
Waterloo, Ontario, Canada, ON N2T 0C1
Windsor, Ontario, Canada, N8X 5A6
Canada, Quebec
Chicoutimi, Quebec, Canada, G7H 5H6
Laval, Quebec, Canada, H7M 3L9
Levis, Quebec, Canada, G6V 4Z5
Montreal, Quebec, Canada, H2W 1T8
Montreal, Quebec, Canada, H3G 1A4
Sherbrooke, Quebec, Canada, J1H 5N4
Terrebonne, Quebec, Canada, J6V 2H2
Thetford Mines, Quebec, Canada, G6G 2V4
Trois-Rivieres, Quebec, Canada, G8Z 4K4
Ontario, Canada, P3E 5M4
Quebec, Canada, G1V 4G5
Temuco, Araucanía, Chile, 2170000
Temuco, Araucanía, Chile, 4781156
Temuco, Araucanía, Chile, 4791348
Concepción, Bío-Bío, Chile, 4070038
Osorno, Los Lagos, Chile, 529000
Valdivia, Los Lagos, Chile
Viña del Mar, Valparaíso, Chile, 2570017
Santiago, Chile, 7500739
Santiago, Chile, 8910108
Santiago, Chile
China, Guangdong
Guangzhou, Guangdong, China, 510080
Guangzhou, Guangdong, China, 510100
China, Hubei
Wudan, Hubei, China, 430022
Wuhan, Hubei, China
China, Hunan
Changsha, Hunan, China, 410011
China, Jiangsu
Nanjing, Jiangsu, China, 210006
Nanjing, Jiangsu, China, 210029
China, Jilin
Changchun, Jilin, China, 130033
Changchun, Jilin, China
China, Liaoning
Shenyang, Liaoning, China, 110004
China, Shanxi
Xi'an, Shanxi, China, 710061
China, Sichuan
Chengdu, Sichuan, China, 610041
China, Zhejiang
Hangzhou, Zhejiang, China, 310003
Hangzhou, Zhejiang, China, 310016
Wenzhou, Zhejiang, China, 325000
Beijing, China, 100029
Beijing, China, 100034
Beijing, China, 100038
Beijing, China, 100088
Beijing, China, 100730
Beijing, China
Shanghai, China, 200001
Shanghai, China, 200003
Shanghai, China, 200025
Shanghai, China, 200030
Shanghai, China, 200032
Shanghai, China, 200080
Barranquilla, Atlántico, Colombia
Cartagena, Bolívar, Colombia
Manizales, Caldas, Colombia
Montería, Córdoba, Colombia, 0
Pasto, Nariño, Colombia
Armenia, Quindío, Colombia
Pereira, Risaralda, Colombia
Bucaramanga, Santander, Colombia
Espinal, Tolima, Colombia
Cali, Valle Del Cauca, Colombia
Barranquilla, Colombia
Colombia, Colombia
Santafe de Bogotá, Colombia
Brno, Czechia, 62500
Brno, Czechia, 656 91
Ceske Budejovice, Czechia, 370 01
Cesky Krumlov, Czechia, 381 27
Hodonin, Czechia, 695 01
Hradec Kralove, Czechia, 500 05
Jablonec nad Nisou, Czechia, 466 60
Kolin, Czechia, 280 02
Liberec, Czechia, 46063
Olomouc, Czechia, 775 20
Ostrava, Czechia, 708 52
Ostrava, Czechia, 728 80
Pardubice, Czechia, 530 03
Praha 10, Czechia, 100 34
Praha 13, Czechia, 158 00
Praha 2, Czechia, 12808
Praha 4, Czechia, 140 21
Praha 5, Czechia, 150 06
Praha 5, Czechia, 150 30
Praha 6, Czechia, 169 02
Slany, Czechia, 274 51
Susice, Czechia, 342 01
Trebic, Czechia, 674 01
Trinec, Czechia, 739 61
Uherske Hradiste, Czechia, 686 68
Zlin, Czechia, 762 75
Aalborg, Denmark, DK-9000
Aarhus N, Denmark, 8200
Hellerup, Denmark, 2900
Holbaek, Denmark, 4300
Hvidovre, Denmark, 2650
Kolding, Denmark, 6000
København Ø, Denmark, 2100
København, Denmark, DK-2400
Viborg, Denmark, 8800
Guayaquil, Guayas, Ecuador
Quito, Pichincha, Ecuador, 0
Quito, Ecuador
Kuopio, Finland, 70100
Kuusankoski, Finland, 45700
Tampere, Finland, 33200
Turku, Finland, FIN-20520
Vantaa, Finland, 01600
Amiens, France, 80000
Clermont Ferrand, France, 63000
Limoges Cedex, France, 87042
Montpellier, France, 34059
Nice, France, 06280
NIMES cedex 9, France, 30029
Paris Cedex 15, France, 75908
Paris, France, 75012
Paris, France, 75018
Saint-priest-en-jarez, France, 42270
Nürnberg, Bayern, Germany, 90402
Würzburg, Bayern, Germany, 97078
Bad Homburg, Hessen, Germany, 61348
Frankfurt, Hessen, Germany, 60594
Kassel, Hessen, Germany, 34128
Bielefeld, Nordrhein-Westfalen, Germany, 33604
Dortmund, Nordrhein-Westfalen, Germany, 44137
Wuppertal, Nordrhein-Westfalen, Germany, 42117
Magdeburg, Sachsen-Anhalt, Germany, 39112
Dresden, Sachsen, Germany, 01067
Leipzig, Sachsen, Germany, 04289
Berlin, Germany, 12351
Berlin, Germany, 12559
Berlin, Germany, 13353
Bottrop, Germany, 46242
Frankfurt, Germany, 65929
Hamburg, Germany, 20099
Warendorf, Germany, 48231
Balatonfured, Hungary, 8230
Budapest, Hungary, 1085
Budapest, Hungary, 1115
Budapest, Hungary, H-1096
Budapest, Hungary, H-1125
Debrecen, Hungary, 4032
Mosonmagyarovar, Hungary, 9200
Pecs, Hungary, 7624
Sopron, Hungary, 9400
Szekesfehervar, Hungary, 8000
Szekszard, Hungary, 7100
Ballinasloe, Co. Galway, Ireland
Cork, Ireland
Dublin, Ireland, 8
Dublin, Ireland, 9
Dublin, Ireland, DUBLIN 7
Galway, Ireland
Afula, Israel, 1834111
Ashkelon, Israel, 7827804
Bnei Brak, Israel
Haifa, Israel, 3109601
Haifa, Israel, 3436212
Holon, Israel, 5810001
Nahariya, Israel, 2210001
Tel Aviv, Israel, 64239
Tel Aviv, Israel
Zefat, Israel, 1311001
Caserta, Campania, Italy, 81027
Bologna, Emilia-Romagna, Italy, 40133
Forlì-Cesena, Emilia-Romagna, Italy, 47100
Ravenna, Emilia-Romagna, Italy, 48010
Trieste, Friuli-Venezia Giulia, Italy, 34149
Udine, Friuli-Venezia Giulia, Italy, 33038
Udine, Friuli-Venezia Giulia, Italy, 33057
Udine, Friuli-Venezia Giulia, Italy, 33100
Brescia, Lombardia, Italy, 25123
Cremona, Lombardia, Italy, 26100
Pavia, Lombardia, Italy, 27100
Ancona, Marche, Italy, 60126
Isernia, Molise, Italy, 86170
Foggia, Puglia, Italy, 71100
Lecce, Puglia, Italy, 73042
Catania, Sicilia, Italy, 95126
Palermo, Sicilia, Italy, 90146
Arezzo, Toscana, Italy, 52040
Firenze, Toscana, Italy, 50053
Perugia, Umbria, Italy, 06024
Terni, Umbria, Italy, 05100
Nagoya, Aichi, Japan, 453-8511
Toyoake, Aichi, Japan, 470-1192
Kisarazu, Chiba, Japan, 292-8535
Matsudo, Chiba, Japan, 270-2251
Imabari, Ehime, Japan, 794-0006
Matsuyama, Ehime, Japan, 790-0062
Kasuga, Fukuoka, Japan, 816-0864
Kitakyushu, Fukuoka, Japan, 802-8555
Miyako-gun, Fukuoka, Japan, 800-0344
Onga-gun, Fukuoka, Japan, 811-4342
Maebashi, Gunma, Japan, 371-0821
Onomichi, Hiroshima, Japan, 722-8503
Asahikawa, Hokkaido, Japan, 070-0038
Asahikawa, Hokkaido, Japan, 070-8610
Sapporo, Hokkaido, Japan, 006-8555
Sapporo, Hokkaido, Japan, 060-0004
Spporo, Hokkaido, Japan, 006-0852
Tomakomai, Hokkaido, Japan, 053-8567
Kobe, Hyogo, Japan, 654-0026
Takarazuka, Hyogo, Japan, 665-0873
Kaga, Ishikawa, Japan, 922-8522
Miura-gun, Kanagawa, Japan, 240-0116
Sagamihara, Kanagawa, Japan, 252-0375
Yokohama, Kanagawa, Japan, 232-0024
Naha, Okinawa, Japan, 902-8511
Kishiwada, Osaka, Japan, 596-8522
Takatsuki, Osaka, Japan, 569-1096
Tokorozawa, Saitama, Japan, 359-1141
Komatsushima, Tokushima, Japan, 773-8502
Akishima, Tokyo, Japan, 196-0003
Bunkyo-ku, Tokyo, Japan, 113-8431
Itabashi-ku, Tokyo, Japan, 173-8610
Shimonoseki, Yamaguchi, Japan, 750-0061
Chiba, Japan, 263-0043
Fukuoka, Japan, 812-0033
Fukuoka, Japan, 814-0180
Gifu, Japan, 500-8384
Gifu, Japan, 500-8717
Kumamoto, Japan, 861-4193
Kyoto, Japan, 600-8558
Kyoto, Japan, 601-1495
Kyoto, Japan, 615-8256
Osaka, Japan, 530-0001
Osaka, Japan, 530-8480
Osaka, Japan, 540-0006
Osaka, Japan, 543-0035
Osaka, Japan, 558-8558
Osaka, Japan, 559-0012
Korea, Republic of
Wonju-si, Gang''weondo, Korea, Republic of, 220-701
Goyang-si, Gyeonggido, Korea, Republic of, 410-773
Seongnam-si, Gyeonggido, Korea, Republic of, 463-707
Jeju, Jejudo, Korea, Republic of, 690767
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 150-713
Busan, Korea, Republic of, 614-735
Daejeon, Korea, Republic of, 302-718
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 134-727
Alor Setar,, Malaysia, 05460
Batu Caves, Selangor, Malaysia, 68100
Kuala Lumpur, Malaysia, 50400
Kuala Lumpur, Malaysia, 59100
Malaysia, Malaysia
Sungai Buloh Selangor, Malaysia, 47000
Amsterdam, Netherlands, 1091 AC
Apeldoorn, Netherlands, 7334 DZ
Arnhem, Netherlands, 6815 AD
Breda, Netherlands, 4818 CK
Delft, Netherlands, 2625 AD
Den Bosch, Netherlands, 5223 GZ
Deventer, Netherlands, 7416 SE
Doetinchem, Netherlands, 7009 BL
Drachten, Netherlands, 9205 NN
EDE, Netherlands, 6716 RP
Gorinchem, Netherlands, 4204 AA
Gouda, Netherlands, 2803 HH
Groningen, Netherlands, 9721 SW
Heerlen, Netherlands, 6401 CX
Helmond, Netherlands, 5707 HA
Hoogeveen, Netherlands, 7909 AA
Hoorn, Netherlands, 1624 NP
Leeuwarden, Netherlands, 8901 BR
Meppel, Netherlands, 7943 KA
Nijmegen, Netherlands, 6532 SZ
Roermond, Netherlands, 6043 CV
Roosendaal, Netherlands, 4708 AE
Rotterdam, Netherlands, 3045 PM
Rotterdam, Netherlands, 3083 AN
Sneek, Netherlands, 8601 ZK
Tiel, Netherlands, 4002 WP
Zwolle, Netherlands, 8011 JW
Cebu City, Philippines, 6000
Dasmarinas, Philippines, 4114
Iloilo City, Philippines, 5000
Manila, Philippines, 1000
Manila, Philippines
Metro Manila, Philippines, 1502
Palawan, Philippines, 5300
Pasig city, Philippines, 1605
Philippines, Philippines
Quezon City, Philippines, 1102
Quezon City, Philippines, 1109
Quezon City, Philippines, NCR 1100
Gdansk, Poland, 80-126
Kielce, Poland, 25-736
Krakow, Poland, 30-001
Krakow, Poland, 30-002
Krakow, Poland, 31-209
Krakow, Poland, 31-501
Lodz, Poland, 91-347
Tarnow, Poland, 33-100
Wroclaw, Poland, 53-114
Timisoara, Timis, Romania, 300079
Brasov, Romania, 500326
Bucharest, Romania, 011461
Bucharest, Romania, 021659
Bucharest, Romania, 022322
Bucharest, Romania, 041915
Bucharest, Romania, 042122
Bucharest, Romania, 050098
Bucharest, Romania, 061114
Bucuresti, Romania, 50659
Cluj Napoca, Romania, 400001
Iasi, Romania, 700503
Iasi, Romania, 700732
Targu Mures, Romania, 540124
Targu Mures, Romania, 540136
Timisoara, Romania, 300310
Russian Federation
Barnaul, Russian Federation, 656038
Kemerovo, Russian Federation, 650002
Moscow, Russian Federation, 101990
Moscow, Russian Federation, 111539
Moscow, Russian Federation, 119991
Moscow, Russian Federation, 121309
Moscow, Russian Federation, 127206
Moscow, Russian Federation, 127473
Novosibirsk, Russian Federation, 630089
Tomsk, Russian Federation, 634012
Tomsk, Russian Federation, 634050
Zhukovskiy, Russian Federation, 140160
Bratislava, Slovakia, 811 04
Bratislava, Slovakia, 813 69
Kosice, Slovakia, 040 22
Nitra, Slovakia, 94901
Presov, Slovakia, 080 81
Vrable, Slovakia, 952 01
South Africa
Pinelands, Eastern Cape, South Africa, 7503
Port Elizabeth, Eastern Cape, South Africa, 6014
Bloemfontein, Freestate, South Africa, 9300
Johannesburg, Gauteng, South Africa, 2157
Cape Town, Western Cape, South Africa, 7531
Observatory, Western Cape, South Africa, 7925
Pinelands, Western Cape, South Africa, 7405
Worcester, Western Cape, South Africa, 6850
Somerset West, South Africa, 7130
Göteborg, Sweden, 413 45
Helsingborg, Sweden, 251 87
Kristianstad, Sweden, 291 85
Skellefteå, Sweden, 931 86
Stockholm, Sweden, 111 35
Stockholm, Sweden, 111 57
Stockholm, Sweden, 141 86
Stockholm, Sweden, 171 76
Vällingby, Sweden, 162 68
Örebro, Sweden, 701 85
Östersund, Sweden, 831 83
Lugano, Ticino, Switzerland, 6900
Dnipropetrovsk, Ukraine, 49 006
Kharkiv, Ukraine, 61002
Kharkiv, Ukraine, 61039
Kharkiv, Ukraine, 61176
Kiev, Ukraine, 02 091
Kiev, Ukraine, 02660
Kiev, Ukraine, 03 049
Lviv, Ukraine, 790 34
Lviv, Ukraine, 79044
Lviv, Ukraine, 79659
Simferopol, Ukraine, 95006
Vinnitsa, Ukraine, 21029
Zaporozhye, Ukraine, 69 000
Zaporozhye, Ukraine, 69118
United Kingdom
Belfast, Antrim, United Kingdom, BT16 1RH
Londonderry Co. Londonderry, Derry, United Kingdom, BT47 6SB
Basildon, Essex, United Kingdom, SS16 5NL
Stevenage, Hertfordshire, United Kingdom, SG1 4AB
Blackpool, Lancashire, United Kingdom, FY4 3AD
Harrow, London, United Kingdom, HA1 3UJ
Portadown, North Ireland, United Kingdom
Middlesborough, North Yorkshire, United Kingdom, TS4 3BW
Northampton, Northamptonshire, United Kingdom, NN1 5BD
Hardwick, Stockton-on-Tees, United Kingdom, TS29 6NH
Nuneaton, Warwickshire, United Kingdom, CV10 7DJ
West Bromich, West Midlands, United Kingdom, B71 4HJ
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Worcester, Worcestershire, United Kingdom, WR5 1DD
Sponsors and Collaborators
Hamilton Health Sciences Corporation, Population Health Research Institute
Janssen Research & Development, LLC
Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Bayer Identifier: NCT01776424     History of Changes
Other Study ID Numbers: 15786
2012-004180-43 ( EudraCT Number )
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Cardiovascular events
blood thinner
coronary disease
artery disease
coronary artery bypass graft
heart attack
arterial vascular disease
transient ischemic attack
heart disease

Additional relevant MeSH terms:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors