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

November 3, 2022 updated by: Bayer

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27395

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Auton. de Buenos Aires, Argentina, C1023AAB
      • Ciudad Auton. de Buenos Aires, Argentina, C1181ACL
      • Ciudad Auton. de Buenos Aires, Argentina, C1405BUB
      • Corrientes, Argentina, 3400
      • Córdoba, Argentina, X5000AAW Córdoba
      • Córdoba, Argentina, X5003DCE
      • Córdoba, Argentina, X5006IKK
      • Córdoba, Argentina, X5000AAX
      • Córdoba, Argentina, X5003DCP
      • Córdoba, Argentina, X5004CDT
      • Salta, Argentina, A4406CLA
      • San Juan, Argentina, 5400
      • San luis, Argentina, 5700
      • Santa Fe, Argentina, S3000FWO
    • Buenos Aires
      • 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
    • Ciudad Auton. De Buenos Aires
      • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1428ART
      • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1119ACN
      • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1440AAD
      • Ciudad Autón. de Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1425AGC
    • Córdoba
      • Villa Allende, Córdoba, Argentina
      • Villa María, Córdoba, Argentina, X5900JKA
    • La Pampa
      • Santa Rosa, La Pampa, Argentina, 6300
    • Santa Fe
      • Rafaela, Santa Fe, Argentina, S2300MMA
      • Rosario, Santa Fe, Argentina, 2000
      • Rosario, Santa Fe, Argentina
      • Rosario, Santa Fe, Argentina, S2005PAF
      • Venado Tuerto, Santa Fe, Argentina, S2600KUE
    • Tucuman
      • San Miguel de Tucumán, Tucuman, Argentina, 4000
      • San Miguel de Tucumán, Tucuman, Argentina, T4000IFL
  • Australia
    • Australian Capital Territory
      • Bruce, Australian Capital Territory, Australia, 2617
    • New South Wales
      • Gosford, New South Wales, Australia, 2250
      • New Lambton Heights, New South Wales, Australia, 2305
      • Taree, New South Wales, Australia, 2430
    • Queensland
      • Birtinya, Queensland, Australia, 4575
      • Brisbane, Queensland, Australia, 4029
      • Brisbane, Queensland, Australia, 4064
      • Redcliffe, Queensland, Australia, 4020
      • Woolloongabba, Queensland, Australia, 4102
    • South Australia
      • Adelaide, South Australia, Australia, 5042
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
      • Launceston, Tasmania, Australia, 7250
    • Victoria
      • Geelong, Victoria, Australia, 3220
      • Melbourne, Victoria, Australia, 3052
      • Melbourne, Victoria, Australia, 3181
      • Prahran, Victoria, Australia, 3181
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
      • Nedlands, Western Australia, Australia, 6009
  • Belgium
      • 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
  • Brazil
      • Sao Paulo, Brazil, 05403-000
    • Goiás
      • Goiania, Goiás, Brazil, 74223 130
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-240
      • Uberaba, Minas Gerais, Brazil, 38025-260
      • Uberlândia, Minas Gerais, Brazil, 38400-368
    • Parana
      • Campina Grande do Sul, Parana, Brazil, 83430 000
      • Curitiba, Parana, Brazil, 80730-150
    • Rio Grande Do Sul
      • Canoas, Rio Grande Do Sul, Brazil, 92425-900
      • Pelotas, Rio Grande Do Sul, Brazil, 96015-290
      • Porto Alegre, Rio Grande Do Sul, Brazil
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90840-440
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90.620-001
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89010 500
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13010-001
      • Campinas, Sao Paulo, Brazil, 13060904
      • Campinas, Sao Paulo, Brazil, 13020-421
      • Matão, Sao Paulo, Brazil, 15990-060
      • São José do Rio Preto, Sao Paulo, Brazil, 15015-750
      • São José do Rio Preto, Sao Paulo, Brazil, 15090
      • São Paulo, Sao Paulo, Brazil, 01506-001
      • São Paulo, Sao Paulo, Brazil, 04012-909
      • Votuporanga, Sao Paulo, Brazil
  • Canada
      • Ontario, Canada, P3E 5M4
      • Quebec, Canada, G1V 4G5
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
      • Edmonton, Alberta, Canada, T6G 2B7
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
      • Victoria, British Columbia, Canada, V8R 4R2
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
      • Winnipeg, Manitoba, Canada, R2H 0R8
      • Winnipeg, Manitoba, Canada, R2V 4W3
      • Winnipeg, Manitoba, Canada, R3T 2E8
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
      • Saint John, New Brunswick, Canada, E2L 4L2
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
    • Ontario
      • Brampton, Ontario, Canada, L6W 2X7
      • Burlington, Ontario, Canada, L7M 4Y1
      • Burlington, Ontario, Canada, L7R 1E2
      • Cambridge, Ontario, Canada, N1R 6V6
      • Cambridge, Ontario, Canada, N1R 7R1
      • Grimsby, Ontario, Canada, L3M 1P3
      • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton, Ontario, Canada, L8M 1K7
      • London, Ontario, Canada, N6A 5A5
      • London, Ontario, Canada, N6G 2M1
      • Mississauga, Ontario, Canada, L5K 2L3
      • Newmarket, Ontario, Canada, L3Y 8C3
      • Newmarket, Ontario, Canada, L3Y 2P6
      • Oakville, Ontario, Canada, L6K 3W7
      • Oshawa, Ontario, Canada, L1J 2J9
      • Oshawa, Ontario, Canada, L1J 2K1
      • Ottawa, Ontario, Canada, K2H 8T5
      • Peterborough, Ontario, Canada, K9J 0B2
      • 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
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
      • Laval, Quebec, Canada, H7M 3L9
      • Levis, Quebec, Canada, G6V 4Z5
      • Montreal, Quebec, Canada, H3G 1A4
      • Montreal, Quebec, Canada, H2W 1T8
      • Sherbrooke, Quebec, Canada, J1H 5N4
      • Terrebonne, Quebec, Canada, J6V 2H2
      • Thetford Mines, Quebec, Canada, G6G 2V4
      • Trois-Rivieres, Quebec, Canada, G8Z 4K4
  • Chile
      • Santiago, Chile
      • Santiago, Chile, 7500739
    • Araucanía
      • Temuco, Araucanía, Chile, 4791348
      • Temuco, Araucanía, Chile, 2170000
      • Temuco, Araucanía, Chile, 4781156
    • Bío-Bío
      • Concepción, Bío-Bío, Chile, 4070038
    • Los Lagos
      • Osorno, Los Lagos, Chile, 5311092
      • Valdivia, Los Lagos, Chile
    • Santiago
      • Providencia, Santiago, Chile, 7500520
      • San Miguel, Santiago, Chile, 8910108
    • Valparaíso
      • Viña del Mar, Valparaíso, Chile, 2570017
  • China
      • Beijing, China
      • Beijing, China, 100730
      • Beijing, China, 100029
      • Beijing, China, 100088
      • Beijing, China, 100034
      • Beijing, China, 100038
      • Shanghai, China, 200032
      • Shanghai, China, 200025
      • Shanghai, China, 200001
      • Shanghai, China, 200030
      • Shanghai, China, 200080
      • Shanghai, China, 200003
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
      • Guangzhou, Guangdong, China, 510100
    • Hubei
      • Wudan, Hubei, China, 430022
      • Wuhan, Hubei, China
    • Hunan
      • Changsha, Hunan, China, 410011
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
      • Nanjing, Jiangsu, China, 210029
    • Jilin
      • Changchun, Jilin, China, 130000
      • Changchun, Jilin, China, 130033
    • Liaoning
      • Shenyang, Liaoning, China, 110004
    • Shanxi
      • Xi'an, Shanxi, China, 710061
    • Sichuan
      • Chengdu, Sichuan, China, 610041
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
      • Hangzhou, Zhejiang, China, 310016
      • Wenzhou, Zhejiang, China, 325000
  • Colombia
      • Barranquilla, Colombia
      • Santafe de Bogotá, Colombia
    • Atlántico
      • Barranquilla, Atlántico, Colombia
    • Bolívar
      • Cartagena, Bolívar, Colombia
    • Caldas
      • Manizales, Caldas, Colombia
    • Córdoba
      • Montería, Córdoba, Colombia, 230002
    • Nariño
      • Pasto, Nariño, Colombia
    • Quindío
      • Armenia, Quindío, Colombia
    • Risaralda
      • Pereira, Risaralda, Colombia
    • Santander
      • Bucaramanga, Santander, Colombia
      • Floridablanca, Santander, Colombia, 681004
    • Tolima
      • Espinal, Tolima, Colombia
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760032
  • Czechia
      • Brno, Czechia, 625 00
      • 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, 460 63
      • Olomouc, Czechia, 779 00
      • 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, 128 08
      • Praha 4, Czechia, 140 21
      • Praha 5, Czechia, 150 06
      • Praha 5, Czechia, 150 30
      • Praha 6, Czechia, 169 02
      • Slany, Czechia, 274 01
      • Susice, Czechia, 342 01
      • Trebic, Czechia, 674 01
      • Trinec, Czechia, 739 61
      • Uherske Hradiste, Czechia, 686 68
      • Zlin, Czechia, 762 75
  • Denmark
      • Aalborg, Denmark, DK-9000
      • Aarhus N, Denmark, 8200
      • Hellerup, Denmark, 2900
      • Holbaek, Denmark, 4300
      • Hvidovre, Denmark, 2650
      • Kolding, Denmark, 6000
      • København, Denmark, DK-2400
      • København Ø, Denmark, 2100
      • Viborg, Denmark, 8800
  • Ecuador
      • Quito, Ecuador
    • Guayas
      • Guayaquil, Guayas, Ecuador
    • Pichincha
      • Quito, Pichincha, Ecuador
  • Finland
      • Kuopio, Finland, 70100
      • Kuusankoski, Finland, 45700
      • Tampere, Finland, 33200
      • Turku, Finland, FIN-20520
      • Vantaa, Finland, 01600
  • France
      • Amiens cedex 1, France, 80054
      • Clermont Ferrand, France, 63000
      • Limoges Cedex, France, 87042
      • Montpellier, France, 34059
      • NIMES cedex 9, France, 30029
      • Nice, France, 06280
      • Paris, France, 75018
      • Paris, France, 75012
      • Paris Cedex 15, France, 75908
      • Saint-priest-en-jarez, France, 42270
  • Germany
      • Berlin, Germany, 13353
      • Berlin, Germany, 12351
      • Berlin, Germany, 12559
      • Bottrop, Germany, 46242
      • Frankfurt, Germany, 65929
      • Hamburg, Germany, 20099
      • Warendorf, Germany, 48231
    • Bayern
      • Nürnberg, Bayern, Germany, 90402
      • Würzburg, Bayern, Germany, 97078
    • Hessen
      • Bad Homburg, Hessen, Germany, 61348
      • Frankfurt, Hessen, Germany, 60596
      • Kassel, Hessen, Germany, 34128
    • Nordrhein-Westfalen
      • Bielefeld, Nordrhein-Westfalen, Germany, 33604
      • Dortmund, Nordrhein-Westfalen, Germany, 44137
      • Wuppertal, Nordrhein-Westfalen, Germany, 42117
    • Sachsen
      • Dresden, Sachsen, Germany, 01067
      • Leipzig, Sachsen, Germany, 04289
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39120
  • Hungary
      • Balatonfured, Hungary, 8230
      • Budapest, Hungary, 1115
      • Budapest, Hungary, 1085
      • Budapest, Hungary, H-1125
      • Budapest, Hungary, H-1096
      • Debrecen, Hungary, 4032
      • Mosonmagyarovar, Hungary, 9200
      • Pecs, Hungary, 7624
      • Sopron, Hungary, 9400
      • Szekesfehervar, Hungary, 8000
      • Szekszard, Hungary, 7100
  • Ireland
      • Cork, Ireland
      • Dublin, Ireland, 9
      • Dublin, Ireland, D07 R2WY
      • Dublin, Ireland, D08 NHY1
      • Galway, Ireland
    • Co. Galway
      • Ballinasloe, Co. Galway, Ireland
  • Israel
      • Afula, Israel, 1834111
      • Ashkelon, Israel, 7830604
      • Bnei Brak, Israel
      • Haifa, Israel, 3109601
      • Haifa, Israel, 3436212
      • Holon, Israel, 5822012
      • Nahariya, Israel, 2210001
      • Tel Aviv, Israel
      • Tel Aviv, Israel, 64239
      • Zefat, Israel, 1311001
  • Italy
    • Campania
      • Caserta, Campania, Italy, 81027
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40133
      • Forlì Cesena, Emilia-Romagna, Italy, 47100
      • Ravenna, Emilia-Romagna, Italy, 48010
    • Friuli-Venezia Giulia
      • Trieste, Friuli-Venezia Giulia, Italy, 34149
      • Udine, Friuli-Venezia Giulia, Italy, 33038
      • Udine, Friuli-Venezia Giulia, Italy, 33057
      • Udine, Friuli-Venezia Giulia, Italy
    • Lombardia
      • Brescia, Lombardia, Italy, 25123
      • Cremona, Lombardia, Italy, 26100
      • Pavia, Lombardia, Italy, 27100
    • Marche
      • Ancona, Marche, Italy, 60126
    • Molise
      • Isernia, Molise, Italy, 86170
    • Puglia
      • Foggia, Puglia, Italy, 71100
      • Lecce, Puglia, Italy, 73042
    • Sicilia
      • Catania, Sicilia, Italy, 95126
      • Palermo, Sicilia, Italy, 90146
    • Toscana
      • Arezzo, Toscana, Italy, 52044
      • Firenze, Toscana, Italy, 50053
    • Umbria
      • Perugia, Umbria, Italy, 06024
      • Terni, Umbria, Italy, 05100
  • Japan
      • Chiba, Japan, 263-0043
      • Fukuoka, Japan, 814-0180
      • Fukuoka, Japan, 812-0033
      • 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, 558-8558
      • Osaka, Japan, 543-0035
      • Osaka, Japan, 559-0012
    • Aichi
      • Nagoya, Aichi, Japan, 453-8511
      • Toyoake, Aichi, Japan, 470-1192
    • Chiba
      • Kisarazu, Chiba, Japan, 292-8535
      • Matsudo, Chiba, Japan, 270-2251
    • Ehime
      • Imabari, Ehime, Japan, 794-0006
      • Matsuyama, Ehime, Japan, 790-0062
    • Fukuoka
      • Kasuga, Fukuoka, Japan, 816-0864
      • Kitakyushu, Fukuoka, Japan, 802-8555
      • Miyako-gun, Fukuoka, Japan, 800-0344
      • Onga-gun, Fukuoka, Japan, 811-4342
    • Gunma
      • Maebashi, Gunma, Japan, 371-0821
    • Hiroshima
      • Onomichi, Hiroshima, Japan, 722-8503
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 070-0038
      • Asahikawa, Hokkaido, Japan, 070-8610
      • Sapporo, Hokkaido, Japan, 006-8555
      • Sapporo, Hokkaido, Japan, 006-0852
      • Sapporo, Hokkaido, Japan, 060-0004
      • Tomakomai, Hokkaido, Japan, 053-8567
    • Hyogo
      • Kobe, Hyogo, Japan, 654-0026
      • Takarazuka, Hyogo, Japan, 665-0873
    • Ishikawa
      • Kaga, Ishikawa, Japan, 922-8522
    • Kanagawa
      • Miura-gun, Kanagawa, Japan, 240-0116
      • Sagamihara, Kanagawa, Japan, 252-0375
      • Yokohama, Kanagawa, Japan, 232-0024
    • Okinawa
      • Naha, Okinawa, Japan, 902-8511
    • Osaka
      • Kishiwada, Osaka, Japan, 596-0042
      • Takatsuki, Osaka, Japan, 569-1096
    • Saitama
      • Tokorozawa, Saitama, Japan, 359-1141
    • Tokushima
      • Komatsushima, Tokushima, Japan, 773-8502
    • Tokyo
      • Akishima, Tokyo, Japan, 196-0003
      • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Itabashi-ku, Tokyo, Japan, 173-8610
    • Yamaguchi
      • Shimonoseki, Yamaguchi, Japan, 750-0061
  • Korea, Republic of
      • Busan, Korea, Republic of, 614-735
      • Daejeon, Korea, Republic of, 302-718
      • Seoul, Korea, Republic of, 110-744
      • Seoul, Korea, Republic of, 03722
      • Seoul, Korea, Republic of, 134-727
    • Gang''weondo
      • Wonju, Gang''weondo, Korea, Republic of, 26426
    • Gyeonggido
      • Goyang-si, Gyeonggido, Korea, Republic of, 10326
      • Seongnam-si, Gyeonggido, Korea, Republic of, 463-707
    • Jejudo
      • Jeju, Jejudo, Korea, Republic of, 690767
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 150-713
  • Malaysia
      • Batu Caves, Selangor, Malaysia, 68100
      • Kedah, Malaysia, 05460
      • Kuala Lumpur, Malaysia, 59100
      • Kuala Lumpur, Malaysia, 50400
      • Selangor, Malaysia, 47000
      • Sungai Buloh Selangor, Malaysia, 47000
  • Netherlands
      • 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
  • Philippines
      • Batangas, Philippines
      • Cebu City, Philippines, 6000
      • Dagupan City, Philippines, 2400
      • Dasmarinas, Philippines, 4114
      • Iloilo City, Philippines, 5000
      • Laoag City, Philippines, 2900
      • Manila, Philippines, 1000
      • Manila, Philippines
      • Metro Manila, Philippines, 1502
      • Muntinlupa City, Philippines, 1780
      • Palawan, Philippines, 5300
      • Pasig city, Philippines, 1605
      • Quezon City, Philippines, NCR 1100
      • Quezon City, Philippines, 1102
      • Quezon City, Philippines, 1109
      • Tacloban City, Philippines, 6500
  • Poland
      • Gdansk, Poland, 80 -126
      • Kielce, Poland, 25-315
      • Krakow, Poland, 31-501
      • Krakow, Poland, 30-002
      • Krakow, Poland, 31-271
      • Krakow, Poland, 31-534
      • Lodz, Poland, 91-347
      • Tarnow, Poland, 33-100
      • Wroclaw, Poland, 53-114
  • Romania
      • Brasov, Romania, 500326
      • Bucharest, Romania, 021659
      • Bucharest, Romania, 041915
      • Bucharest, Romania, 042122
      • Bucharest, Romania, 050098
      • Bucharest, Romania, 011461
      • Bucharest, Romania, 022322
      • 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
    • Timis
      • Timisoara, Timis, Romania, 300254
  • Russian Federation
      • Barnaul, Russian Federation, 656038
      • Kemerovo, Russian Federation, 650002
      • Moscow, Russian Federation, 111539
      • Moscow, Russian Federation, 121309
      • Moscow, Russian Federation, 119435
      • Moscow, Russian Federation, 101990
      • Moscow, Russian Federation, 127206
      • Moscow, Russian Federation, 107084
      • Moscow, Russian Federation, 117556
      • Novosibirsk, Russian Federation, 630089
      • Tomsk, Russian Federation, 634012
      • Zhukovskiy, Russian Federation, 140160
  • Slovakia
      • Bratislava, Slovakia, 813 69
      • Bratislava, Slovakia, 811 04
      • Kosice, Slovakia, 040 22
      • Nitra, Slovakia, 94901
      • Presov, Slovakia, 080 81
      • Vrable, Slovakia, 952 01
  • South Africa
      • Somerset West, South Africa, 7130
    • Eastern Cape
      • Pinelands, Eastern Cape, South Africa, 7503
      • Port Elizabeth, Eastern Cape, South Africa, 6014
    • Freestate
      • Bloemfontein, Freestate, South Africa, 9300
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2157
    • Western Cape
      • 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
  • Sweden
      • Göteborg, Sweden, 413 45
      • Helsingborg, Sweden, 251 87
      • Kristianstad, Sweden, 291 85
      • Skellefteå, Sweden, 931 86
      • Stockholm, Sweden, 171 76
      • Stockholm, Sweden, 141 86
      • Stockholm, Sweden, 114 46
      • Stockholm, Sweden, 111 35
      • Vällingby, Sweden, 162 68
      • Örebro, Sweden, 701 85
      • Östersund, Sweden, 831 83
  • Switzerland
    • Ticino
      • Lugano, Ticino, Switzerland, 6900
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49 006
      • Kharkiv, Ukraine, 61002
      • Kharkiv, Ukraine, 61039
      • Kharkiv, Ukraine, 61176
      • Kiev, Ukraine, 02660
      • Kiev, Ukraine, 02 091
      • Kiev, Ukraine, 03 049
      • Lviv, Ukraine, 79659
      • Lviv, Ukraine, 790 34
      • Lviv, Ukraine, 79044
      • Simferopol, Ukraine, 95006
      • Vinnitsa, Ukraine, 21029
      • Zaporozhye, Ukraine, 69 000
      • Zaporozhye, Ukraine, 69118
  • United Kingdom
    • Antrim
      • Belfast, Antrim, United Kingdom, BT16 1RH
    • Derry
      • Londonderry Co. Londonderry, Derry, United Kingdom, BT47 6SB
    • Essex
      • Basildon, Essex, United Kingdom, SS16 5NL
    • Hertfordshire
      • Stevenage, Hertfordshire, United Kingdom, SG1 4AB
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY4 3AD
    • London
      • Harrow, London, United Kingdom, HA1 3UJ
    • North Ireland
      • Portadown, North Ireland, United Kingdom
    • North Yorkshire
      • Middlesborough, North Yorkshire, United Kingdom, TS4 3BW
    • Northamptonshire
      • Northampton, Northamptonshire, United Kingdom, NN1 5BD
    • Stockton-on-Tees
      • Hardwick, Stockton-on-Tees, United Kingdom, TS29 6NH
    • Warwickshire
      • Nuneaton, Warwickshire, United Kingdom, CV10 7DJ
    • West Midlands
      • West Bromich, West Midlands, United Kingdom, B71 4HJ
      • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
    • Worcestershire
      • Worcester, Worcestershire, United Kingdom, WR5 1DD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
      • Mobile, Alabama, United States, 36608
    • 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
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
      • Stamford, Connecticut, United States, 06905
      • Trumbull, Connecticut, United States, 06611
    • Florida
      • Atlantis, Florida, United States, 33462
      • Clearwater, Florida, United States, 33756
      • Coral Springs, Florida, United States, 33065
      • Jacksonville Beach, Florida, United States, 32250
      • Largo, Florida, United States, 33770
      • New Port Richey, Florida, United States, 34653
      • Safety Harbor, Florida, United States, 34695
      • Sarasota, Florida, United States, 34239
    • Idaho
      • Meridian, Idaho, United States, 83716
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
      • Hazel Crest, Illinois, United States, 60429
    • Iowa
      • Davenport, Iowa, United States, 52803
      • West Des Moines, Iowa, United States, 50266
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017-5460
    • Maryland
      • Baltimore, Maryland, United States, 21215
    • Massachusetts
      • Haverhill, Massachusetts, United States, 01830
    • Michigan
      • Alpena, Michigan, United States, 49707
      • Jackson, Michigan, United States, 49201
    • Missouri
      • Saint Louis, Missouri, United States, 63136
    • Montana
      • Kalispell, Montana, United States, 59901
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
    • New York
      • Cortlandt Manor, New York, United States, 10567
      • Kingston, New York, United States, 12401
      • Saratoga Springs, New York, United States, 12866
    • North Carolina
      • Durham, North Carolina, United States, 27713
      • Pinehurst, North Carolina, United States, 28374
    • Ohio
      • Elyria, Ohio, United States, 44035
      • Sandusky, Ohio, United States, 44870
      • Toledo, Ohio, United States, 43606
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
      • Langhorne, Pennsylvania, United States, 19047
      • Yardley, Pennsylvania, United States, 19067
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
    • Texas
      • Dallas, Texas, United States, 75216-7167
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77030-4298
      • San Antonio, Texas, United States, 78229
    • Washington
      • Bellevue, Washington, United States, 98004-4623
      • Puyallup, Washington, United States, 98372
      • Seattle, Washington, United States, 98195
      • Spokane, Washington, United States, 99204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rivaroxaban 2.5mg + Aspirin 100mg
Participants 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.
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Tablet, 2.5 mg, twice daily, oral
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Tablet, 5 mg, twice daily, oral
Drug: Aspirin
Tablet, 100 mg, once daily, oral
Drug: Pantoprazole
Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole
Drug: Pantoprazole placebo
Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo
Experimental: Rivaroxaban 5mg + Aspirin Placebo
Participants 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.
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Tablet, 2.5 mg, twice daily, oral
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Tablet, 5 mg, twice daily, oral
Drug: Pantoprazole
Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole
Drug: Pantoprazole placebo
Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo
Drug: Aspirin placebo
Aspirin matching placebo, once daily, oral
Active Comparator: Rivaroxaban Placebo + Aspirin 100mg
Participants 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.
Drug: Aspirin
Tablet, 100 mg, once daily, oral
Drug: Pantoprazole
Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole
Drug: Pantoprazole placebo
Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo
Drug: Rivaroxaban placebo
Rivaroxaban matching placebo, twice daily, oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death
Time Frame: 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.
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
Time Frame: 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.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death
Time Frame: 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.
Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CHD death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
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
Time Frame: 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.
Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
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
Time Frame: 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.
Count of participants and time from randomization to death by all cause were evaluated. Hazard ratios were calculated and reported as statistical analysis.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death in LTOLE Part
Time Frame: 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.
Count of participants from COMPASS LTOLE initiation visit to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. LTOLE: long-term open-lable extension
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
Time Frame: 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.

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 from COMPASS LTOLE initiation visit to the first occurrence of the primary safety outcome major bleeding was evaluated. LTOLE: long-term open-lable extension
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
Time Frame: 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.
Count of participants from COMPASS LTOLE initiation visit to death by all cause were evaluated. LTOLE: long-term open-lable extension
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC
Population Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2013

Primary Completion (Actual)

July 21, 2017

Study Completion (Actual)

June 15, 2021

Study Registration Dates

First Submitted

January 24, 2013

First Submitted That Met QC Criteria

January 25, 2013

First Posted (Estimate)

January 28, 2013

Study Record Updates

Last Update Posted (Actual)

November 28, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15786
  • 2012-004180-43 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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