Study Completed

Prevention & control

Bayer Identifier:

15786

ClinicalTrials.gov Identifier:

NCT01776424

EudraCT Number:

2012-004180-43

EU CT Number:

Not Available

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

Trial summary

Enrollment Goal

27395

Trial Dates

February 2013 - June 2021

Phase

Phase 3

Could I Receive a placebo

Products

Xarelto (Rivaroxaban, BAY59-7939)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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

Additional Information

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