check_circleStudy Completed

Prevention & control

Rivaroxaban for the prevention of major cardiovascular events in coronary or peripheral artery disease

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
27395
Trial Dates
February 2013 - June 2021
Phase
Phase 3
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Lugano, 6900, Switzerland
Completed
Forlì Cesena, 47100, Italy
Completed
Trieste, 34149, Italy
Completed
Catania, 95126, Italy
Completed
Arezzo, 52044, Italy
Completed
Foggia, 71100, Italy
Completed
Caserta, 81027, Italy
Completed
Lecce, 73042, Italy
Completed
Firenze, 50053, Italy
Completed
Cremona, 26100, Italy
Completed
Udine, 33038, Italy
Completed
Perugia, 06024, Italy
Completed
Terni, 05100, Italy
Completed
LIMOGES CEDEX, 87042, France
Completed
NICE, 06280, France
Completed
PARIS CEDEX 15, 75908, France
Completed
Paris, 75018, France
Completed
Bunkyo-ku, 113-8431, Japan
Completed
Toyoake, 470-1192, Japan
Completed
PARIS, 75012, France
Completed
MONTPELLIER, 34059, France
Completed
Komatsushima, 773-8502, Japan
Completed
Itabashi-ku, 173-8610, Japan
Completed
Osaka, 530-0001, Japan
Completed
Yokohama, 232-0024, Japan
Completed
Osaka, 543-0035, Japan
Completed
Zefat, 1311001, Israel
Completed
Holon, 5822012, Israel
Completed
Tel Aviv, 64239, Israel
Completed
Afula, 1834111, Israel
Completed
Bnei Brak, Israel
Completed
Haifa, 3436212, Israel
Completed
Ashkelon, 7830604, Israel
Completed
Nahariya, 2210001, Israel
Completed
Tel Aviv, Israel
Completed
Gifu, 500-8717, Japan
Completed
Hamilton, L8L 2X2, Canada
Completed
Hamilton, L8L 2X2, Canada
Completed
Debrecen, 4032, Hungary
Completed
Pecs, 7624, Hungary
Completed
Szekszard, 7100, Hungary
Completed
Balatonfured, 8230, Hungary
Completed
Budapest, H-1125, Hungary
Completed
Mosonmagyarovar, 9200, Hungary
Completed
Szekesfehervar, 8000, Hungary
Completed
Budapest, H-1096, Hungary
Completed
Budapest, 1085, Hungary
Completed
Osaka, 558-8558, Japan
Completed
Ballinasloe, Ireland
Completed
Dublin, 9, Ireland
Completed
Galway, Ireland
Completed
Dublin, D08 NHY1, Ireland
Completed
Dublin, D07 R2WY, Ireland
Completed
Cork, Ireland
Completed
ARNHEM, 6815 AD, Netherlands
Completed
Campina Grande do Sul, 83430 000, Brazil
Completed
Porto Alegre, 90020-090, Brazil
Completed
Campinas, 13010-001, Brazil
Completed
Blumenau, 89010 500, Brazil
Completed
Goiania, 74223 130, Brazil
Completed
Oshawa, L1J 2K1, Canada
Completed
Oakville, L6K 3W7, Canada
Completed
Stockholm, 171 76, Sweden
Completed
Östersund, 831 83, Sweden
Completed
Göteborg, 413 45, Sweden
Completed
Kristianstad, 291 85, Sweden
Completed
Göteborg, 413 45, Sweden
Completed
Skellefteå, 931 86, Sweden
Completed
Stockholm, 111 35, Sweden
Completed
Örebro, 701 85, Sweden
Completed
Stockholm, 141 86, Sweden
Completed
Helsingborg, 251 87, Sweden
Completed
Stockholm, 114 46, Sweden
Completed
Vällingby, 162 68, Sweden
Completed
Trebic, 674 01, Czechia
Completed
Trinec, 739 61, Czechia
Completed
Olomouc, 779 00, Czechia
Withdrawn
Mlada Boleslav, 293 50, Czechia
Completed
Kolin, 280 02, Czechia
Completed
Pardubice, 530 03, Czechia
Completed
Praha 2, 128 08, Czechia
Completed
Praha 4, 140 21, Czechia
Completed
Jablonec nad Nisou, 466 60, Czechia
Completed
Slany, 274 01, Czechia
Completed
Susice, 342 01, Czechia
Completed
Uherske Hradiste, 686 68, Czechia
Completed
Ostrava, 728 80, Czechia
Completed
Praha 10, 100 34, Czechia
Completed
Brno, 625 00, Czechia
Completed
Praha 6, 169 02, Czechia
Completed
Hradec Kralove, 500 05, Czechia
Completed
Ceske Budejovice, 370 01, Czechia
Completed
Olomouc, 779 00, Czechia
Completed
Praha 5, 150 30, Czechia
Completed
Praha 2, 128 08, Czechia
Completed
Brno, 656 91, Czechia
Completed
Praha 5, 150 06, Czechia
Completed
Praha 10, 100 34, Czechia
Completed
Rosario, 2000, Argentina
Completed
La Plata, 1900, Argentina
Completed
Zárate, B2800DGH, Argentina
Completed
Santa Fe, S3000FWO, Argentina
Completed
San Miguel de Tucumán, 4000, Argentina
Completed
Coronel Suarez, B7540GHD, Argentina
Completed
Buenos Aires, C1119ACN, Argentina
Completed
Bahía Blanca, 8000, Argentina
Completed
Quilmes, 1878, Argentina
Completed
Adrogue, 1846, Argentina
Completed
Salta, A4406CLA, Argentina
Completed
Mar del Plata, B7600FZN, Argentina
Completed
San Martín, 1650, Argentina
Completed
Buenos Aires, C1428ART, Argentina
Completed
Córdoba, X5000AAW Córdoba, Argentina
Completed
Ramos Mejía, B1740ETD, Argentina
Completed
La Plata, B1902AGY, Argentina
Completed
Venado Tuerto, S2600KUE, Argentina
Completed
San Nicolás, B2900DMH, Argentina
Completed
Córdoba, X5000AAX, Argentina
Completed
Rafaela, S2300MMA, Argentina
Completed
Villa María, X5900JKA, Argentina
Completed
Junín, B6000BHA, Argentina
Completed
Santa Rosa, 6300, Argentina
Completed
San luis, 5700, Argentina
Completed
Villa Allende, Argentina
Completed
San Juan, 5400, Argentina
Completed
Rosario, 2000, Argentina
Completed
Corrientes, 3400, Argentina
Completed
Munro, B1605DSX, Argentina
Completed
São Paulo, 04012-909, Brazil
Completed
Pelotas, 96015-290, Brazil
Completed
Porto Alegre, 90840-440, Brazil
Completed
Belo Horizonte, 30150-240, Brazil
Completed
Campinas, 13060904, Brazil
Completed
São José do Rio Preto, 15090, Brazil
Completed
Votuporanga, Brazil
Completed
Canoas, 92425-900, Brazil
Completed
Campinas, 13020-421, Brazil
Completed
Uberlândia, 38400-368, Brazil
Completed
Porto Alegre, 90.620-001, Brazil
Completed
São Paulo, 04012-909, Brazil
Completed
Sao Paulo, 05403-000, Brazil
Completed
São Paulo, 04012-909, Brazil
Completed
São José do Rio Preto, 15015-750, Brazil
Completed
Curitiba, 80730-150, Brazil
Completed
BREDA, 4818 CK, Netherlands
Completed
HOORN, 1624 NP, Netherlands
Completed
HELMOND, 5707 HA, Netherlands
Completed
LEEUWARDEN, 8901 BR, Netherlands
Completed
AMSTERDAM, 1091 AC, Netherlands
Completed
HEERLEN, 6401 CX, Netherlands
Completed
DEVENTER, 7416 SE, Netherlands
Completed
GORINCHEM, 4204 AA, Netherlands
Completed
SNEEK, 8601 ZK, Netherlands
Completed
GOUDA, 2803 HH, Netherlands
Completed
ROERMOND, 6043 CV, Netherlands
Completed
HOOGEVEEN, 7909 AA, Netherlands
Completed
ROOSENDAAL, 4708 AE, Netherlands
Completed
NIJMEGEN, 6532 SZ, Netherlands
Completed
ROTTERDAM, 3083 AN, Netherlands
Completed
Galway, Ireland
Completed
Kasuga, 816-0864, Japan
Completed
Kobe, 654-0026, Japan
Completed
Grimsby, L3M 1P3, Canada
Completed
Udine, Italy
Completed
Udine, 33057, Italy
Completed
Isernia, 86170, Italy
Completed
Ancona, 60126, Italy
Completed
Palermo, 90146, Italy
Completed
Cambridge, N1R 7R1, Canada
Completed
Würzburg, 97078, Germany
Completed
Magdeburg, 39120, Germany
Completed
Berlin, 13353, Germany
Completed
Frankfurt, 65929, Germany
Completed
Bielefeld, 33604, Germany
Completed
Nürnberg, 90402, Germany
Completed
Kassel, 34128, Germany
Completed
Berlin, 12559, Germany
Completed
Frankfurt, 60596, Germany
Completed
Kyoto, 600-8558, Japan
Completed
Quebec, G1V 4G5, Canada
Completed
Moncton, E1G 1A7, Canada
Completed
Dortmund, 44137, Germany
Completed
Warendorf, 48231, Germany
Completed
Osaka, 530-8480, Japan
Completed
Stamford, 06905, United States
Completed
Winnipeg, R2V 4W3, Canada
Completed
Burlington, L7R 1E2, Canada
Completed
Kielce, 25-315, Poland
Completed
Krakow, 31-534, Poland
Completed
Krakow, 31-271, Poland
Completed
Tarnow, 33-100, Poland
Completed
Gdansk, 80 -126, Poland
Completed
Lodz, 91-347, Poland
Completed
Wroclaw, 53-114, Poland
Completed
Krakow, 31-501, Poland
Completed
Winnipeg, R2H 0R8, Canada
Completed
DEN BOSCH, 5223 GZ, Netherlands
Completed
ZWOLLE, 8011 JW, Netherlands
Completed
DELFT, 2625 AD, Netherlands
Completed
Tiel, 4002 WP, Netherlands
Completed
Temuco, 2170000, Chile
Completed
Santiago, Chile
Completed
Viña del Mar, 2570017, Chile
Completed
Osorno, 5311092, Chile
Completed
Burlington, L7M 4Y1, Canada
Completed
Hamilton, L8M 1K7, Canada
Completed
Trumbull, 06611, United States
Completed
Norwalk, 06851, United States
Completed
Anaheim, 92801, United States
Completed
Jacksonville Beach, 32250, United States
Completed
Haverhill, 01830, United States
Completed
Largo, 33770, United States
Completed
Langhorne, 19047, United States
Completed
Pinehurst, 28374, United States
Completed
Asahikawa, 070-8610, Japan
Completed
Kishiwada, 596-0042, Japan
Completed
Alpena, 49707, United States
Completed
Santa Rosa, 95494, United States
Completed
Coral Springs, 33065, United States
Completed
Yardley, 19067, United States
Completed
Mobile, 36608, United States
Completed
Clearwater, 33756, United States
Completed
Kalispell, 59901, United States
Completed
Saratoga Springs, 12866, United States
Completed
Cortlandt Manor, 10567, United States
Completed
Safety Harbor, 34695, United States
Completed
Kingston, 12401, United States
Completed
Birmingham, 35294, United States
Completed
Sandusky, 44870, United States
Completed
Seattle, 98195, United States
Completed
Puyallup, 98372, United States
Completed
Elyria, 44035, United States
Completed
West Des Moines, 50266, United States
Completed
Northridge, 91324, United States
Completed
New Port Richey, 34653, United States
Completed
Sarasota, 34239, United States
Completed
Spokane, 99204, United States
Completed
Meridian, 83716, United States
Completed
San Antonio, 78229, United States
Completed
Laguna Hills, 92653, United States
Completed
Sylmar, 91342, United States
Completed
Toledo, 43606, United States
Completed
St. Louis, 63136, United States
Completed
Brampton, L6W 2X7, Canada
Completed
Observatory, 7925, South Africa
Completed
Bloemfontein, 9300, South Africa
Completed
Somerset West, 7130, South Africa
Completed
Port Elizabeth, 6014, South Africa
Completed
Worcester, 6850, South Africa
Completed
Pinelands, 7405, South Africa
Completed
Cape Town, 7531, South Africa
Completed
Pinelands, 7503, South Africa
Completed
Somerset West, 7130, South Africa
Completed
Johannesburg, 2157, South Africa
Completed
Peterborough, K9J 0B2, Canada
Completed
Mississauga, L5K 2L3, Canada
Completed
Quebec, G1V 4G5, Canada
Completed
Levis, G6V 4Z5, Canada
Completed
Waterloo, ON N2T 0C1, Canada
Completed
Newmarket, L3Y 8C3, Canada
Completed
Kiev, 03 049, Ukraine
Completed
Kiev, 02660, Ukraine
Completed
Kharkiv, 61039, Ukraine
Completed
Kharkiv, 61176, Ukraine
Completed
Kharkiv, 61002, Ukraine
Completed
Galway, Ireland
Completed
Haifa, 3109601, Israel
Completed
Sopron, 9400, Hungary
Completed
Budapest, 1115, Hungary
Completed
Balatonfured, 8230, Hungary
Completed
Barranquilla, Colombia
Completed
Barranquilla, Colombia
Completed
Oshawa, L1J 2J9, Canada
Completed
Providencia, 7500520, Chile
Completed
San Miguel, 8910108, Chile
Completed
Valdivia, Chile
Completed
Concepción, 4070038, Chile
Completed
Victoria, V8R 4R2, Canada
Completed
Scarborough, M1E 5E9, Canada
Completed
Newmarket, L3Y 2P6, Canada
Completed
Ottawa, K2H 8T5, Canada
Completed
Ostrava, 708 52, Czechia
Completed
Floridablanca, 681004, Colombia
Completed
Wolverhampton, WV10 0QP, United Kingdom
Completed
Nuneaton, CV10 7DJ, United Kingdom
Completed
Portadown, United Kingdom
Completed
Harrow, HA1 3UJ, United Kingdom
Completed
Basildon, SS16 5NL, United Kingdom
Completed
Blackpool, FY4 3AD, United Kingdom
Completed
Belfast, BT16 1RH, United Kingdom
Completed
Worcester, WR5 1DD, United Kingdom
Completed
Hardwick, TS29 6NH, United Kingdom
Completed
Londonderry Co. Londonderry, BT47 6SB, United Kingdom
Completed
Cesky Krumlov, 381 27, Czechia
Completed
Espinal, Colombia
Completed
Cartagena, Colombia
Completed
Pereira, Colombia
Completed
Armenia, Colombia
Completed
Liberec, 460 63, Czechia
Completed
Batu Caves, Selangor, 68100, Malaysia
Completed
Sungai Buloh Selangor, 47000, Malaysia
Completed
Kedah, 05460, Malaysia
Withdrawn
Kelantan, 15200, Malaysia
Completed
Kuala Lumpur, 59100, Malaysia
Completed
Quezon City, 1109, Philippines
Completed
Vantaa, 01600, Finland
Completed
Brno, 656 91, Czechia
Completed
Ostrava, 708 52, Czechia
Completed
Bologna, 40133, Italy
Completed
Windsor, N8X 5A6, Canada
Completed
Sherbrooke, J1H 5N4, Canada
Completed
Kuopio, 70100, Finland
Completed
Kuusankoski, 45700, Finland
Completed
Fukuoka, 814-0180, Japan
Completed
Tampere, 33200, Finland
Completed
Zlin, 762 75, Czechia
Completed
Praha 4, 140 21, Czechia
Completed
Praha 5, 150 30, Czechia
Completed
Manizales, Colombia
Completed
Jeju, 690767, Korea, Republic Of
Completed
Montreal, H3G 1A4, Canada
Completed
New Westminster, V3L 3W4, Canada
Completed
Thetford Mines, G6G 2V4, Canada
Completed
Sudbury, P3E 1H5, Canada
Completed
Calgary, T2N 4Z6, Canada
Completed
Santafe de Bogotá, Colombia
Completed
Cambridge, N1R 6V6, Canada
Completed
Zaporozhye, 69118, Ukraine
Completed
Lviv, 79659, Ukraine
Completed
Simferopol, 95006, Ukraine
Completed
Barranquilla, Colombia
Completed
Pasto, Colombia
Completed
Cartagena, Colombia
Completed
Sioux Falls, 57108, United States
Completed
Davenport, 52803, United States
Completed
DAEJEON, 302-718, Korea, Republic Of
Completed
Seongnam-si, 463-707, Korea, Republic Of
Completed
Seoul, 134-727, Korea, Republic Of
Completed
Busan, 614-735, Korea, Republic Of
Completed
Seoul, 110-744, Korea, Republic Of
Completed
Seoul, 03722, Korea, Republic Of
Completed
Seoul, 150-713, Korea, Republic Of
Completed
Goyang-si, 10326, Korea, Republic Of
Completed
Quezon City, NCR 1100, Philippines
Completed
Iloilo City, 5000, Philippines
Completed
Manila, 1000, Philippines
Completed
Durham, 27713, United States
Completed
Houston, 77030-4298, United States
Completed
Hazel Crest, 60429, United States
Completed
New Brunswick, 08901, United States
Completed
Montreal, H2W 1T8, Canada
Completed
Montreal, H2W 1T8, Canada
Completed
Trois-Rivieres, G8Z 4K4, Canada
Completed
Chicoutimi, G7H 5H6, Canada
Completed
Pavia, 27100, Italy
Completed
Atlantis, 33462, United States
Completed
Tokorozawa, 359-1141, Japan
Completed
SAINT-PRIEST-EN-JAREZ, 42270, France
Completed
São Paulo, 01506-001, Brazil
Completed
Matão, 15990-060, Brazil
Completed
Porto Alegre, Brazil
Completed
Uberaba, 38025-260, Brazil
Completed
Sao Paulo, 05403-000, Brazil
Completed
Akishima, 196-0003, Japan
Completed
Onomichi, 722-8503, Japan
Completed
Matsudo, 270-2251, Japan
Completed
Sapporo, 006-0852, Japan
Completed
Takatsuki, 569-1096, Japan
Completed
Fukuoka, 812-0033, Japan
Completed
Wonju, 26426, Korea, Republic Of
Completed
Naha, 902-8511, Japan
Completed
Chiba, 263-0043, Japan
Completed
Nagoya, 453-8511, Japan
Completed
Miura-gun, 240-0116, Japan
Completed
Shimonoseki, 750-0061, Japan
Completed
Kisarazu, 292-8535, Japan
Completed
Sapporo, 060-0004, Japan
Completed
Imabari, 794-0006, Japan
Completed
Laval, H7M 3L9, Canada
Completed
Asahikawa, 070-0038, Japan
Completed
GRONINGEN, 9721 SW, Netherlands
Completed
EDE, 6716 RP, Netherlands
Completed
ROTTERDAM, 3045 PM, Netherlands
Completed
MEPPEL, 7943 KA, Netherlands
Completed
APELDOORN, 7334 DZ, Netherlands
Completed
DOETINCHEM, 7009 BL, Netherlands
Completed
Sapporo, 006-8555, Japan
Completed
Manila, Philippines
Completed
Metro Manila, 1502, Philippines
Completed
Palawan, 5300, Philippines
Completed
Dasmarinas, 4114, Philippines
Completed
Pasig city, 1605, Philippines
Completed
Quezon City, 1102, Philippines
Completed
Cebu City, 6000, Philippines
Completed
Moscow, 101990, Russian Federation
Completed
Moscow, 107084, Russian Federation
Completed
Moscow, 117556, Russian Federation
Completed
Zhukovskiy, 140160, Russian Federation
Completed
Kemerovo, 650002, Russian Federation
Completed
Novosibirsk, 630089, Russian Federation
Completed
Tomsk, 634012, Russian Federation
Completed
Tomsk, 634012, Russian Federation
Completed
Barnaul, 656038, Russian Federation
Completed
Barnaul, 656038, Russian Federation
Completed
Moscow, 119435, Russian Federation
Completed
Moscow, 111539, Russian Federation
Completed
Moscow, 121309, Russian Federation
Completed
Moscow, 127206, Russian Federation
Completed
Hamburg, 20099, Germany
Completed
Praha 13, 158 00, Czechia
Completed
Bratislava, 811 04, Slovakia
Withdrawn
Kosice, 04011, Slovakia
Completed
Nitra, 94901, Slovakia
Completed
Presov, 080 81, Slovakia
Completed
Bratislava, 813 69, Slovakia
Completed
Kosice, 040 22, Slovakia
Completed
Vrable, 952 01, Slovakia
Completed
Osaka, 540-0006, Japan
Completed
Stockholm, 171 76, Sweden
Completed
Brescia, 25123, Italy
Completed
Miyako-gun, 800-0344, Japan
Completed
Sagamihara, 252-0375, Japan
Completed
Onga-gun, 811-4342, Japan
Completed
Temuco, 4791348, Chile
Completed
Santiago, Chile
Completed
Temuco, 4781156, Chile
Completed
Kaga, 922-8522, Japan
Completed
Matsuyama, 790-0062, Japan
Completed
Murdoch, 6150, Australia
Completed
New Lambton Heights, 2305, Australia
Completed
Hobart, 7000, Australia
Completed
Gosford, 2250, Australia
Completed
Redcliffe, 4020, Australia
Completed
Brisbane, 4064, Australia
Completed
Prahran, 3181, Australia
Completed
Melbourne, 3181, Australia
Withdrawn
Melbourne, 3004, Australia
Completed
Geelong, 3220, Australia
Completed
Bruce, 2617, Australia
Completed
Melbourne, 3052, Australia
Completed
Launceston, 7250, Australia
Completed
Adelaide, 5042, Australia
Completed
Nedlands, 6009, Australia
Completed
Gifu, 500-8384, Japan
Completed
Tomakomai, 053-8567, Japan
Completed
Takarazuka, 665-0873, Japan
Completed
Bellevue, 98004-4623, United States
Completed
Dallas, 75216-7167, United States
Completed
Doylestown, 18901, United States
Completed
Doylestown, 18901, United States
Completed
Arlington Heights, 60005, United States
Completed
Bucaramanga, Colombia
Completed
Ravenna, 48010, Italy
Completed
Merlo, B1722COV, Argentina
Completed
Rosario, Argentina
Completed
Brisbane, 4029, Australia
Completed
Woolloongabba, 4102, Australia
Completed
Cali, 760032, Colombia
Completed
Osaka, 559-0012, Japan
Completed
Torrance, 90502-2004, United States
Completed
Terrebonne, J6V 2H2, Canada
Completed
Winnipeg, R2H 2A6, Canada
Completed
Saint John, E2L 4L2, Canada
Completed
Barranquilla, Colombia
Withdrawn
Chía, Colombia
Completed
Xi'an, 710061, China
Completed
Beijing, 100029, China
Completed
Beijing, 100730, China
Completed
Beijing, 100029, China
Completed
Beijing, 100038, China
Completed
Beijing, China
Completed
Guangzhou, 510100, China
Completed
Shanghai, 200080, China
Completed
Shenyang, 110004, China
Completed
Changchun, 130000, China
Completed
Changchun, 130033, China
Completed
Hangzhou, 310003, China
Completed
Chengdu, 610041, China
Completed
Beijing, 100088, China
Completed
Wudan, 430022, China
Completed
Beijing, China
Withdrawn
Changsha, 410008, China
Completed
Maebashi, 371-0821, Japan
Completed
København, DK-2400, Denmark
Completed
Hellerup, 2900, Denmark
Completed
Holbaek, 4300, Denmark
Completed
Hvidovre, 2650, Denmark
Completed
Kolding, 6000, Denmark
Completed
Kolding, 6000, Denmark
Completed
Shanghai, 200003, China
Completed
shanghai, 200001, China
Completed
Shanghai, 200032, China
Completed
Shanghai, 200025, China
Completed
Beijing, China
Completed
Nanjing, 210006, China
Completed
Beijing, 100034, China
Completed
Wenzhou, 325000, China
Completed
Hangzhou, 310016, China
Completed
Nanjing, 210029, China
Completed
Guangzhou, 510080, China
Completed
Shanghai, 200032, China
Completed
Changsha, 410011, China
Completed
København Ø, 2100, Denmark
Completed
Viborg, 8800, Denmark
Completed
Aalborg, DK-9000, Denmark
Completed
Aarhus N, 8200, Denmark
Completed
Wuhan, China
Completed
Córdoba, X5006IKK, Argentina
Completed
Córdoba, X5003DCE, Argentina
Completed
Córdoba, X5004CDT, Argentina
Completed
La Plata, B1902COS, Argentina
Completed
Vicente López, B1602ABQ, Argentina
Completed
Ciudad Auton. de Buenos Aires, C1405BUB, Argentina
Completed
Rosario, S2005PAF, Argentina
Completed
Ciudad Autón. de Buenos Aires, C1425AGC, Argentina
Completed
La Plata, B1902CNF, Argentina
Completed
Ciudad Auton. de Buenos Aires, C1181ACL, Argentina
Completed
Buenos Aires, C1440AAD, Argentina
Completed
San Miguel de Tucumán, T4000IFL, Argentina
Completed
Kyoto, 615-8256, Japan
Completed
Dresden, 01067, Germany
Completed
Bottrop, 46242, Germany
Completed
DRACHTEN, 9205 NN, Netherlands
Completed
Kyoto, 601-1495, Japan
Completed
Berlin, 12351, Germany
Completed
Shanghai, 200030, China
Completed
Kiev, 02 091, Ukraine
Completed
Lviv, 790 34, Ukraine
Completed
Ciudad Auton. de Buenos Aires, C1023AAB, Argentina
Completed
Córdoba, X5003DCP, Argentina
Completed
Santiago, 7500739, Chile
Completed
Halifax, B3H 3A7, Canada
Completed
Winnipeg, R3T 2E8, Canada
Completed
Kitakyushu, 802-8555, Japan
Completed
Crestview Hills, 41017-5460, United States
Completed
Kumamoto, 861-4193, Japan
Completed
West Bromich, B71 4HJ, United Kingdom
Completed
Northampton, NN1 5BD, United Kingdom
Completed
Middlesborough, TS4 3BW, United Kingdom
Completed
Stevenage, SG1 4AB, United Kingdom
Completed
Bucharest, 050098, Romania
Completed
Bucharest, 050098, Romania
Completed
Bucharest, 041915, Romania
Completed
Bucharest, 022322, Romania
Completed
Bucharest, 061114, Romania
Completed
Bucharest, 021659, Romania
Completed
BIRTINYA, 4575, Australia
Completed
Taree, 2430, Australia
Completed
Iasi, 700503, Romania
Completed
Targu Mures, 540124, Romania
Completed
Targu Mures, 540136, Romania
Completed
Brasov, 500326, Romania
Completed
Timisoara, 300310, Romania
Completed
Cluj Napoca, 400001, Romania
Completed
Bucuresti, 50659, Romania
Completed
Timisoara, 300254, Romania
Completed
Timisoara, 300310, Romania
Completed
Bucharest, 042122, Romania
Completed
Iasi, 700732, Romania
Completed
Bucharest, 022322, Romania
Completed
Bucharest, 011461, Romania
Completed
Hodonin, 695 01, Czechia
Completed
LEUVEN, 3000, Belgium
Completed
ROESELARE, 8800, Belgium
Completed
LIEGE, 4000, Belgium
Completed
CHARLEROI, 6000, Belgium
Completed
GENK, 3600, Belgium
Completed
BRUXELLES - BRUSSEL, 1070, Belgium
Completed
BONHEIDEN, 2820, Belgium
Completed
Bad Homburg, 61348, Germany
Completed
Leipzig, 04289, Germany
Completed
Wuppertal, 42117, Germany
Completed
Baltimore, 21215, United States
Completed
Quito, Ecuador
Completed
Guayaquil, Ecuador
Completed
Guayaquil, Ecuador
Completed
Quito, Ecuador
Completed
Sudbury, P3E 6C3, Canada
Completed
London, N6A 5A5, Canada
Completed
Ontario, P3E 5M4, Canada
Completed
London, N6G 2M1, Canada
Completed
Turku, FIN-20520, Finland
Completed
Laoag City, 2900, Philippines
Completed
Tacloban City, 6500, Philippines
Completed
Batangas, Philippines
Completed
Muntinlupa City, 1780, Philippines
Completed
Dagupan City, 2400, Philippines
Completed
Amiens cedex 1, 80054, France
Completed
BRUGGE, 8000, Belgium
Completed
KORTRIJK, 8500, Belgium
Completed
Dnipropetrovsk, 49 006, Ukraine
Completed
Zaporozhye, 69 000, Ukraine
Completed
Lviv, 79044, Ukraine
Completed
NIMES cedex 9, 30029, France
Completed
CLERMONT FERRAND, 63000, France
Completed
Montería, 230002, Colombia
Completed
Edmonton, T6G 2B7, Canada
Withdrawn
Evanston, 60201, United States
Completed
Jackson, 49201, United States
Completed
Kuala Lumpur, 50400, Malaysia
Completed
Palo Alto, 94304-1207, United States
Completed
Houston, 77030, United States
Completed
Toronto, M4N 3M5, Canada
Completed
ANTWERPEN, 2020, Belgium
Completed
HASSELT, 3500, Belgium
Completed
Moscow, 101990, Russian Federation
Completed
Selangor, 47000, Malaysia
Completed
Vinnitsa, 21029, Ukraine
Completed
Balatonfured, 8230, Hungary
Completed
Quito, Ecuador
Completed
Quito, Ecuador
Completed
Quito, Ecuador
Completed
Krakow, 30-002, Poland
Completed
Guayaquil, Ecuador

Primary Outcome

  • The first occurrence of the composite primary efficacy outcome, myocardial infarction (MI), stroke, or cardiovascular (CV) death
    Count of participants and time from randomization to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
    date_rangeTime 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.
    enhanced_encryption
    Safety Issue:
    No
  • The first occurrence of the primary safety outcome major bleeding based on a modification of the International Society on Thrombosis and Haemostasis (ISTH) criteria
    Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day). Count of participants and time from randomization to the first occurrence of the primary safety outcome major bleeding were evaluated. Hazard ratios were calculated and reported as statistical analysis.
    date_rangeTime 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.
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • The first occurrence of myocardial infarction (MI), ischemic stroke, acute limb ischemia (ALI), or coronary heart disease (CHD) death
    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.
    date_rangeTime 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.
    enhanced_encryption
    Safety Issue:
    No
  • The first occurrence of MI, ischemic stroke, ALI, or cardiovascular (CV) death
    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.
    date_rangeTime 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.
    enhanced_encryption
    Safety Issue:
    No
  • All-cause mortality
    Count of participants and time from randomization to death by all cause were evaluated. Hazard ratios were calculated and reported as statistical analysis.
    date_rangeTime 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.
    enhanced_encryption
    Safety Issue:
    No

Trial design

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).
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3