Prevention & ControlPhase 3COMPASSNCT01776424
Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939), Aspirin and Pantoprazole in people with Prevention & Control, run by Bayer at 565 sites in 33 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prevention & Control
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939), Aspirin and Pantoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27,395 participants
- Where
- 565 sitesin 33 countries
- Study dates
- 28 Feb 2013to 15 Jun 2021
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
565 sites in 33 countries.
565 sites in 33 countries
United States53 sites
Study site
Alpena, Michigan, 49707
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Anaheim, California, 92801
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Arlington Heights, Illinois, 60005
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Atlantis, Florida, 33462
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Baltimore, Maryland, 21215
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Bellevue, Washington, 98004-4623
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Birmingham, Alabama, 35294
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Clearwater, Florida, 33756
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Coral Springs, Florida, 33065
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Cortlandt Manor, New York, 10567
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Crestview Hills, Kentucky, 41017-5460
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Dallas, Texas, 75216-7167
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Davenport, Iowa, 52803
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Doylestown, Pennsylvania, 18901
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Durham, North Carolina, 27713
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Elyria, Ohio, 44035
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Haverhill, Massachusetts, 01830
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Hazel Crest, Illinois, 60429
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Houston, Texas, 77030-4298
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Houston, Texas, 77030
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Jackson, Michigan, 49201
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Jacksonville Beach, Florida, 32250
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Kalispell, Montana, 59901
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Kingston, New York, 12401
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Laguna Hills, California, 92653
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Langhorne, Pennsylvania, 19047
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Largo, Florida, 33770
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Meridian, Idaho, 83716
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Mobile, Alabama, 36608
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New Brunswick, New Jersey, 08901
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New Port Richey, Florida, 34653
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Northridge, California, 91324
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Norwalk, Connecticut, 06851
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Palo Alto, California, 94304-1207
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Pinehurst, North Carolina, 28374
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Puyallup, Washington, 98372
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Safety Harbor, Florida, 34695
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San Antonio, Texas, 78229
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Sandusky, Ohio, 44870
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Santa Rosa, California, 95494
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Sarasota, Florida, 34239
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Saratoga Springs, New York, 12866
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Seattle, Washington, 98195
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Sioux Falls, South Dakota, 57108
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Spokane, Washington, 99204
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St Louis, Missouri, 63136
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Stamford, Connecticut, 06905
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Sylmar, California, 91342
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Toledo, Ohio, 43606
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Torrance, California, 90502-2004
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Trumbull, Connecticut, 06611
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West Des Moines, Iowa, 50266
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Yardley, Pennsylvania, 19067
Japan48 sites
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Akishima, Tokyo, 196-0003
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Asahikawa, Hokkaido, 070-0038
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Asahikawa, Hokkaido, 070-8610
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Bunkyo-ku, Tokyo, 113-8431
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Chiba, 263-0043
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Fukuoka, 812-0033
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Fukuoka, 814-0180
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Gifu, 500-8384
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Gifu, 500-8717
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Imabari, Ehime, 794-0006
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Itabashi-ku, Tokyo, 173-8610
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Kaga, Ishikawa-ken, 922-8522
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Kasuga, Fukuoka, 816-0864
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Kisarazu, Chiba, 292-8535
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Kishiwada, Osaka, 596-0042
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Kitakyushu, Fukuoka, 802-8555
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Kobe, Hyōgo, 654-0026
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Komatsushimachō, Tokushima, 773-8502
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Kumamoto, 861-4193
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Kyoto, 600-8558
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Kyoto, 601-1495
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Kyoto, 615-8256
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Maebashi, Gunma, 371-0821
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Matsudo, Chiba, 270-2251
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Matsuyama, Ehime, 790-0062
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Miura-gun, Kanagawa, 240-0116
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Miyako-gun, Fukuoka, 800-0344
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Nagoya, Aichi-ken, 453-8511
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Naha, Okinawa, 902-8511
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Onga-gun, Fukuoka, 811-4342
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Onomichi, Hiroshima, 722-8503
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Osaka, 530-0001
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Osaka, 530-8480
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Osaka, 540-0006
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Osaka, 543-0035
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Osaka, 558-8558
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Osaka, 559-0012
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Sagamihara, Kanagawa, 252-0375
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Sapporo, Hokkaido, 006-0852
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Sapporo, Hokkaido, 006-8555
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Sapporo, Hokkaido, 060-0004
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Shimonoseki, Yamaguchi, 750-0061
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Takarazuka, Hyōgo, 665-0873
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Takatsuki, Osaka, 569-1096
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Tokorozawa, Saitama, 359-1141
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Tomakomai, Hokkaido, 053-8567
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Toyoake, Aichi-ken, 470-1192
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Yokohama, Kanagawa, 232-0024
Canada46 sites
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Brampton, Ontario, L6W 2X7
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Burlington, Ontario, L7M 4Y1
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Burlington, Ontario, L7R 1E2
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Calgary, Alberta, T2N 4Z6
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Cambridge, Ontario, N1R 6V6
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Cambridge, Ontario, N1R 7R1
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Chicoutimi, Quebec, G7H 5H6
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Edmonton, Alberta, T6G 2B7
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Greater Sudbury, Ontario, P3E 1H5
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Greater Sudbury, Ontario, P3E 6C3
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Grimsby, Ontario, L3M 1P3
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Halifax, Nova Scotia, B3H 3A7
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Hamilton, Ontario, L8L 2X2
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Hamilton, Ontario, L8M 1K7
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Laval, Quebec, H7M 3L9
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Lévis, Quebec, G6V 4Z5
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London, Ontario, N6A 5A5
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London, Ontario, N6G 2M1
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Mississauga, Ontario, L5K 2L3
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Moncton, New Brunswick, E1G 1A7
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Montreal, Quebec, H2W 1T8
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Montreal, Quebec, H3G 1A4
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New Westminster, British Columbia, V3L 3W4
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Newmarket, Ontario, L3Y 2P6
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Newmarket, Ontario, L3Y 8C3
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Oakville, Ontario, L6K 3W7
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Ontario, P3E 5M4
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Oshawa, Ontario, L1J 2J9
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Oshawa, Ontario, L1J 2K1
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Ottawa, Ontario, K2H 8T5
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Peterborough, Ontario, K9J 0B2
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Québec, G1V 4G5
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Saint John, New Brunswick, E2L 4L2
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Scarborough Village, Ontario, M1E 5E9
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Sherbrooke, Quebec, J1H 5N4
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Terrebonne, Quebec, J6V 2H2
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Thetford-Mines, Quebec, G6G 2V4
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Toronto, Ontario, M4N 3M5
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Trois-Rivières, Quebec, G8Z 4K4
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Victoria, British Columbia, V8R 4R2
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Waterloo, Ontario, ON N2T 0C1
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Windsor, Ontario, N8X 5A6
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Winnipeg, Manitoba, R2H 0R8
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Winnipeg, Manitoba, R2H 2A6
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Winnipeg, Manitoba, R2V 4W3
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Winnipeg, Manitoba, R3T 2E8
Argentina45 sites
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Adrogué, Buenos Aires, 1846
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Bahía Blanca, Buenos Aires, 8000
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Buenos Aires, Ciudad Auton. de Buenos Aires, C1119ACN
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Buenos Aires, Ciudad Auton. de Buenos Aires, C1428ART
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Buenos Aires, Ciudad Auton. de Buenos Aires, C1440AAD
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Ciudad Auton. de Buenos Aires, C1023AAB
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Ciudad Auton. de Buenos Aires, C1181ACL
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Ciudad Auton. de Buenos Aires, C1405BUB
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Ciudad Autón. de Buenos Aires, Ciudad Auton. de Buenos Aires, C1425AGC
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Córdoba, X5000AAW Córdoba
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Córdoba, X5000AAX
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Córdoba, X5003DCE
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Córdoba, X5003DCP
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Córdoba, X5004CDT
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Córdoba, X5006IKK
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Coronel Suárez, Buenos Aires, B7540GHD
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Corrientes, 3400
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Junín, Buenos Aires, B6000BHA
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La Plata, Buenos Aires, 1900
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La Plata, Buenos Aires, B1902AGY
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La Plata, Buenos Aires, B1902CNF
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La Plata, Buenos Aires, B1902COS
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Mar del Plata, Buenos Aires, B7600FZN
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Merlo, Buenos Aires, B1722COV
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Munro, Buenos Aires, B1605DSX
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Quilmes, Buenos Aires, 1878
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Rafaela, Santa Fe Province, S2300MMA
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Ramos Mejía, Buenos Aires, B1740ETD
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Rosario, Santa Fe Province, 2000
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Rosario, Santa Fe Province, S2005PAF
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Rosario, Santa Fe Province
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Salta, A4406CLA
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San Juan, 5400
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San Luis, 5700
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San Martín, Buenos Aires, 1650
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San Miguel de Tucumán, Tucumán Province, 4000
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San Miguel de Tucumán, Tucumán Province, T4000IFL
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San Nicolás de los Arroyos, Buenos Aires, B2900DMH
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Santa Fe, S3000FWO
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Santa Rosa, La Pampa Province, 6300
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Venado Tuerto, Santa Fe Province, S2600KUE
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Vicente López, Buenos Aires, B1602ABQ
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Villa Allende, Córdoba Province
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Villa María, Córdoba Province, X5900JKA
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Zárate, Buenos Aires, B2800DGH
China27 sites
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Beijing, 100029
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Beijing, 100034
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Beijing, 100038
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Beijing, 100088
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Beijing, 100730
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Beijing
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Changchun, Jilin, 130000
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Changchun, Jilin, 130033
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Changsha, Hunan, 410011
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Chengdu, Sichuan, 610041
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Guangzhou, Guangdong, 510080
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Guangzhou, Guangdong, 510100
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Hangzhou, Zhejiang, 310003
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Hangzhou, Zhejiang, 310016
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Nanjing, Jiangsu, 210006
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Nanjing, Jiangsu, 210029
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Shanghai, 200001
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Shanghai, 200003
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Shanghai, 200025
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Shanghai, 200030
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Shanghai, 200032
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Shanghai, 200080
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Shenyang, Liaoning, 110004
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Wenzhou, Zhejiang, 325000
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Wudan, Hubei, 430022
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Wuhan, Hubei
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Xi’an, Shanxi, 710061
Netherlands27 sites
Study site
's-Hertogenbosch, 5223 GZ
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Amsterdam, 1091 AC
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Apeldoorn, 7334 DZ
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Arnhem, 6815 AD
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Breda, 4818 CK
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Delft, 2625 AD
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Deventer, 7416 SE
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Doetinchem, 7009 BL
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Drachten, 9205 NN
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Ede, 6716 RP
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Gorinchem, 4204 AA
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Gouda, 2803 HH
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Groningen, 9721 SW
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Heerlen, 6401 CX
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Helmond, 5707 HA
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Hoogeveen, 7909 AA
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Hoorn, 1624 NP
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Leeuwarden, 8901 BR
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Meppel, 7943 KA
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Nijmegen, 6532 SZ
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Roermond, 6043 CV
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Roosendaal, 4708 AE
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Rotterdam, 3045 PM
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Rotterdam, 3083 AN
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Sneek, 8601 ZK
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Tiel, 4002 WP
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Zwolle, 8011 JW
Czechia26 sites
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Brno, 625 00
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Brno, 656 91
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České Budějovice, 370 01
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Český Krumlov, 381 27
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Hodonín, 695 01
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Hradec Králové, 500 05
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Jablonec nad Nisou, 466 60
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Kolín, 280 02
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Liberec, 460 63
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Olomouc, 779 00
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Ostrava, 708 52
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Ostrava, 728 80
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Pardubice, 530 03
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Prague, 100 34
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Prague, 128 08
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Prague, 140 21
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Prague, 150 06
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Prague, 150 30
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Prague, 158 00
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Prague, 169 02
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Slaný, 274 01
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Sušice, 342 01
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Třebíč, 674 01
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Třinec, 739 61
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Uherské Hradiště, 686 68
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Zlín, 762 75
Brazil23 sites
Study site
Belo Horizonte, Minas Gerais, 30150-240
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Blumenau, Santa Catarina, 89010 500
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Campina Grande do Sul, Paraná, 83430 000
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Campinas, São Paulo, 13010-001
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Campinas, São Paulo, 13020-421
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Campinas, São Paulo, 13060904
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Canoas, Rio Grande do Sul, 92425-900
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Curitiba, Paraná, 80730-150
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Goiânia, Goiás, 74223 130
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Matão, São Paulo, 15990-060
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Pelotas, Rio Grande do Sul, 96015-290
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Porto Alegre, Rio Grande do Sul, 90.620-001
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Porto Alegre, Rio Grande do Sul, 90020-090
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Porto Alegre, Rio Grande do Sul, 90840-440
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Porto Alegre, Rio Grande do Sul
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São José do Rio Preto, São Paulo, 15015-750
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São José do Rio Preto, São Paulo, 15090
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São Paulo, São Paulo, 01506-001
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São Paulo, São Paulo, 04012-909
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São Paulo, 05403-000
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Uberaba, Minas Gerais, 38025-260
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Uberlândia, Minas Gerais, 38400-368
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Votuporanga, São Paulo
Italy21 sites
Study site
Ancona, The Marches, 60126
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Arezzo, Tuscany, 52044
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Bologna, Emilia-Romagna, 40133
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Brescia, Lombardy, 25123
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Caserta, Campania, 81027
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Catania, Sicily, 95126
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Cremona, Lombardy, 26100
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Florence, Tuscany, 50053
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Foggia, Apulia, 71100
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Forlì Cesena, Emilia-Romagna, 47100
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Isernia, Molise, 86170
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Lecce, Apulia, 73042
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Palermo, Sicily, 90146
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Pavia, Lombardy, 27100
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Perugia, Umbria, 06024
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Ravenna, Emilia-Romagna, 48010
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Terni, Umbria, 05100
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Trieste, Friuli Venezia Giulia, 34149
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Udine, Friuli Venezia Giulia, 33038
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Udine, Friuli Venezia Giulia, 33057
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Udine, Friuli Venezia Giulia
Australia18 sites
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Adelaide, South Australia, 5042
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Birtinya, Queensland, 4575
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Brisbane, Queensland, 4029
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Brisbane, Queensland, 4064
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Bruce, Australian Capital Territory, 2617
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Geelong, Victoria, 3220
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Gosford, New South Wales, 2250
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Hobart, Tasmania, 7000
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Launceston, Tasmania, 7250
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Melbourne, Victoria, 3052
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Melbourne, Victoria, 3181
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Murdoch, Western Australia, 6150
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Nedlands, Western Australia, 6009
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New Lambton Heights, New South Wales, 2305
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Prahran, Victoria, 3181
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Redcliffe, Queensland, 4020
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Taree, New South Wales, 2430
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Woolloongabba, Queensland, 4102
Germany18 sites
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Bad Homburg, Hesse, 61348
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Berlin, 12351
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Berlin, 12559
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Berlin, 13353
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Bielefeld, North Rhine-Westphalia, 33604
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Bottrop, 46242
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Dortmund, North Rhine-Westphalia, 44137
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Dresden, Saxony, 01067
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Frankfurt, 65929
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Frankfurt am Main, Hesse, 60596
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Hamburg, 20099
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Kassel, Hesse, 34128
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Leipzig, Saxony, 04289
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Magdeburg, Saxony-Anhalt, 39120
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Nuremberg, Bavaria, 90402
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Warendorf, 48231
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Wuppertal, North Rhine-Westphalia, 42117
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Würzburg, Bavaria, 97078
Philippines16 sites
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Batangas
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Cebu City, 6000
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City of Muntinlupa, 1780
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Dagupan, 2400
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Dasmariñas, 4114
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Iloilo City, 5000
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Laoag, 2900
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Manila, 1000
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Manila
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Metro Manila, 1502
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Palawan, 5300
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Pasig, 1605
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Quezon City, 1102
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Quezon City, 1109
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Quezon City, NCR 1100
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Tacloban City, 6500
Romania16 sites
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Brasov, 500326
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Bucharest, 011461
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Bucharest, 021659
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Bucharest, 022322
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Bucharest, 041915
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Bucharest, 042122
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Bucharest, 050098
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Bucharest, 061114
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Bucharest, 50659
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Cluj-Napoca, 400001
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Iași, 700503
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Iași, 700732
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Târgu Mureş, 540124
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Târgu Mureş, 540136
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Timișoara, Timiș County, 300254
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Timișoara, 300310
Ukraine14 sites
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Dnipropetrovsk, 49 006
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Kharkiv, 61002
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Kharkiv, 61039
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Kharkiv, 61176
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Kiev, 02 091
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Kiev, 02660
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Kiev, 03 049
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Lviv, 790 34
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Lviv, 79044
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Lviv, 79659
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Simferopol, 95006
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Vinnitsa, 21029
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Zaporizhzhya, 69 000
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Zaporizhzhya, 69118
United Kingdom14 sites
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Basildon, Essex, SS16 5NL
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Belfast, Antrim, BT16 1RH
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Blackpool, Lancashire, FY4 3AD
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Hardwick, Stockton-on-Tees, TS29 6NH
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Harrow, London, HA1 3UJ
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Londonderry Co. Londonderry, Derry, BT47 6SB
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Middlesbrough, North Yorkshire, TS4 3BW
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Northampton, Northamptonshire, NN1 5BD
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Nuneaton, Warwickshire, CV10 7DJ
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Portadown, North Ireland
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Stevenage, Hertfordshire, SG1 4AB
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West Bromich, West Midlands, B71 4HJ
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Wolverhampton, West Midlands, WV10 0QP
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Worcester, Worcestershire, WR5 1DD
Colombia13 sites
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Armenia, Quindío Department
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Barranquilla, Atlántico
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Barranquilla
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Bogotá
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Bucaramanga, Santander Department
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Cali, Valle del Cauca Department, 760032
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Cartagena, Departamento de Bolívar
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Espinal, Tolima Department
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Floridablanca, Santander Department, 681004
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Manizales, Caldas Department
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Montería, Departamento de Córdoba, 230002
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Pasto, Departamento de Nariño
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Pereira, Risaralda Department
Russia12 sites
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Barnaul, 656038
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Kemerovo, 650002
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Moscow, 101990
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Moscow, 107084
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Moscow, 111539
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Moscow, 117556
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Moscow, 119435
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Moscow, 121309
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Moscow, 127206
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Novosibirsk, 630089
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Tomsk, 634012
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Zhukovskiy, 140160
Belgium11 sites
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Antwerp, 2020
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Bonheiden, 2820
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Bruges, 8000
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Bruxelles - Brussel, 1070
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Charleroi, 6000
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Genk, 3600
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Hasselt, 3500
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Kortrijk, 8500
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Leuven, 3000
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Liège, 4000
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Roeselare, 8800
Chile11 sites
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Concepción, Bío-Bío, 4070038
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Osorno, Los Lagos Region, 5311092
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Providencia, Santiago Metropolitan, 7500520
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San Miguel, Santiago Metropolitan, 8910108
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Santiago, 7500739
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Santiago
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Temuco, Araucania, 2170000
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Temuco, Araucania, 4781156
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Temuco, Araucania, 4791348
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Valdivia, Los Lagos Region
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Viña del Mar, Valparaiso, 2570017
Hungary11 sites
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Balatonfüred, 8230
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Budapest, 1085
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Budapest, 1115
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Budapest, H-1096
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Budapest, H-1125
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Debrecen, 4032
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Mosonmagyaróvár, 9200
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Pécs, 7624
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Sopron, 9400
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Székesfehérvár, 8000
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Szekszárd, 7100
Sweden11 sites
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Gothenburg, 413 45
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Helsingborg, 251 87
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Kristianstad, 291 85
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Örebro, 701 85
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Östersund, 831 83
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Skellefteå, 931 86
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Stockholm, 111 35
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Stockholm, 114 46
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Stockholm, 141 86
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Stockholm, 171 76
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Vällingby, 162 68
France10 sites
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Amiens, 80054
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Clermont-Ferrand, 63000
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Limoges, 87042
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Montpellier, 34059
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Nice, 06280
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Nîmes, 30029
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Paris, 75012
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Paris, 75018
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Paris, 75908
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Saint-Priest-en-Jarez, 42270
Israel10 sites
Study site
Afula, 1834111
Study site
Ashkelon, 7830604
Study site
Bnei Brak
Study site
Haifa, 3109601
Study site
Haifa, 3436212
Study site
Holon, 5822012
Study site
Nahariya, 2210001
Study site
Safed, 1311001
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Tel Aviv, 64239
Study site
Tel Aviv
South Korea10 sites
Study site
Busan, 614-735
Study site
Daejeon, 302-718
Study site
Goyang-si, Gyeonggido, 10326
Study site
Jeju City, Jeju-do, 690767
Study site
Seongnam-si, Gyeonggido, 463-707
Study site
Seoul, Seoul Teugbyeolsi, 150-713
Study site
Seoul, 03722
Study site
Seoul, 110-744
Study site
Seoul, 134-727
Study site
Wŏnju, Gang''weondo, 26426
Denmark9 sites
Study site
Aalborg, DK-9000
Study site
Aarhus N, 8200
Study site
Copenhagen, DK-2400
Study site
Hellerup, 2900
Study site
Holbæk, 4300
Study site
Hvidovre, 2650
Study site
København Ø, 2100
Study site
Kolding, 6000
Study site
Viborg, 8800
Poland9 sites
Study site
Gdansk, 80 -126
Study site
Kielce, 25-315
Study site
Krakow, 30-002
Study site
Krakow, 31-271
Study site
Krakow, 31-501
Study site
Krakow, 31-534
Study site
Lodz, 91-347
Study site
Tarnów, 33-100
Study site
Wroclaw, 53-114
South Africa9 sites
Study site
Bloemfontein, Freestate, 9300
Study site
Cape Town, Western Cape, 7531
Study site
Johannesburg, Gauteng, 2157
Study site
Observatory, Western Cape, 7925
Study site
Pinelands, Eastern Cape, 7503
Study site
Pinelands, Western Cape, 7405
Study site
Port Elizabeth, Eastern Cape, 6014
Study site
Somerset West, 7130
Study site
Worcester, Western Cape, 6850
Ireland6 sites
Study site
Ballinasloe, Co. Galway
Study site
Cork
Study site
Dublin, 9
Study site
Dublin, D07 R2WY
Study site
Dublin, D08 NHY1
Study site
Galway
Malaysia6 sites
Study site
Batu Caves, Selangor, 68100
Study site
Kedah, 05460
Study site
Kuala Lumpur, 50400
Study site
Kuala Lumpur, 59100
Study site
Kuala Selangor, 47000
Study site
Sungai Buloh Selangor, 47000
Slovakia6 sites
Study site
Bratislava, 811 04
Study site
Bratislava, 813 69
Study site
Košice, 040 22
Study site
Nitra, 94901
Study site
Prešov, 080 81
Study site
Vráble, 952 01
Finland5 sites
Study site
Kuopio, 70100
Study site
Kuusankoski, 45700
Study site
Tampere, 33200
Study site
Turku, FIN-20520
Study site
Vantaa, 01600
Ecuador3 sites
Study site
Guayaquil, Guayas
Study site
Quito, Pichincha, 0
Study site
Quito
About this study
Official title: A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease (COMPASS - Cardiovascular OutcoMes for People Using Anticoagulation StrategieS).
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.
- Conditions
- Prevention & Control
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939), Aspirin, Aspirin placebo, Rivaroxaban placebo, Pantoprazole
- Keywords
- Cardiovascular events, Rivaroxaban, Xarelto, Anticoagulant, Blood thinner, Aspirin, ASA, Coronary artery disease, CAD, Peripheral artery disease, PAD, Artery disease, Coronary artery bypass graft, Stroke, Heart attack, Angina, Arterial vascular disease, Myocardial infarction, MI, Cardiovascular Death
- Medical subject headings
- Coronary Artery Disease, Peripheral Arterial Disease, Stroke, Myocardial Infarction, Angina Pectoris, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
Tablet, 2.5 mg, twice daily, oral
Rivaroxaban (Xarelto, BAY59-7939)Drug
Tablet, 5 mg, twice daily, oral
AspirinDrug
Tablet, 100 mg, once daily, oral
Aspirin placeboDrug
Aspirin matching placebo, once daily, oral
Rivaroxaban placeboDrug
Rivaroxaban matching placebo, twice daily, oral
PantoprazoleDrug
Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole
Pantoprazole placeboDrug
Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban 2.5mg + Aspirin 100mg | Experimental | 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. Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Aspirin; Drug: Pantoprazole; Drug: Pantoprazole placebo |
| Rivaroxaban 5mg + Aspirin Placebo | Experimental | 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. Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Aspirin placebo; Drug: Pantoprazole; Drug: Pantoprazole placebo |
| Rivaroxaban Placebo + Aspirin 100mg | Active comparator | 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. Receives: Drug: Aspirin; Drug: Rivaroxaban placebo; Drug: Pantoprazole; Drug: Pantoprazole placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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 outcomes (3)
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.
Measured: 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
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.
Measured: 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
Count of participants and time from randomization to death by all cause were evaluated. Hazard ratios were calculated and reported as statistical analysis.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study start28 Feb 2013
- Primary completion21 Jul 2017
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (66)Papers the sponsor has linked to this study.
- Other trials for Prevention & ControlStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27,395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Population Health Research Institute, Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776424
- Sponsor's protocol ID
- 15786
- Other IDs
- 2012-004180-43
- Acronym
- COMPASS
- Status last verified
- Nov 2022
- First submitted
- 24 Jan 2013
- Last updated
- 28 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Eikelboom JW, Bosch J, Connolly SJ, Tyrwitt J, Fox KAA, Muehlhofer E, Neumann C, Tasto C, Bangdiwala SI, Diaz R, Alings M, Dagenais GR, Leong DP, Lonn EM, Avezum A, Piegas LS, Widimsky P, Parkhomenko AN, Bhatt DL, Branch KRH, Probstfield JL, Lopez-Jaramillo P, Ryden L, Pogosova N, Keltai K, Keltai M, Ertl G, Stoerk S, Dans AL, Lanas F, Liang Y, Zhu J, Torp-Pedersen C, Maggioni AP, Commerford PJ, Guzik TJ, Vanassche T, Verhamme P, O'Donnell M, Tonkin AM, Varigos JD, Vinereanu D, Felix C, Kim JH, Ibrahim KS, Lewis BS, Metsarinne KP, Aboyans V, Steg PG, Hori M, Kakkar A, Anand SS, Lamy A, Sharma M, Yusuf S. Long-Term Treatment with the Combination of Rivaroxaban and Aspirin in Patients with Chronic Coronary or Peripheral Artery Disease: Outcomes During the Open Label Extension of the COMPASS trial. Eur Heart J Cardiovasc Pharmacother. 2022 Dec 2;8(8):786-795. doi: 10.1093/ehjcvp/pvac023.
PubMed 35383832Anand SS, Caron F, Eikelboom JW, Bosch J, Dyal L, Aboyans V, Abola MT, Branch KRH, Keltai K, Bhatt DL, Verhamme P, Fox KAA, Cook-Bruns N, Lanius V, Connolly SJ, Yusuf S. Major Adverse Limb Events and Mortality in Patients With Peripheral Artery Disease: The COMPASS Trial. J Am Coll Cardiol. 2018 May 22;71(20):2306-2315. doi: 10.1016/j.jacc.2018.03.008. Epub 2018 Mar 11.
PubMed 29540326Anand SS, Bosch J, Eikelboom JW, Connolly SJ, Diaz R, Widimsky P, Aboyans V, Alings M, Kakkar AK, Keltai K, Maggioni AP, Lewis BS, Stork S, Zhu J, Lopez-Jaramillo P, O'Donnell M, Commerford PJ, Vinereanu D, Pogosova N, Ryden L, Fox KAA, Bhatt DL, Misselwitz F, Varigos JD, Vanassche T, Avezum AA, Chen E, Branch K, Leong DP, Bangdiwala SI, Hart RG, Yusuf S; COMPASS Investigators. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2018 Jan 20;391(10117):219-229. doi: 10.1016/S0140-6736(17)32409-1. Epub 2017 Nov 10.
PubMed 29132880Connolly SJ, Eikelboom JW, Bosch J, Dagenais G, Dyal L, Lanas F, Metsarinne K, O'Donnell M, Dans AL, Ha JW, Parkhomenko AN, Avezum AA, Lonn E, Lisheng L, Torp-Pedersen C, Widimsky P, Maggioni AP, Felix C, Keltai K, Hori M, Yusoff K, Guzik TJ, Bhatt DL, Branch KRH, Cook Bruns N, Berkowitz SD, Anand SS, Varigos JD, Fox KAA, Yusuf S; COMPASS investigators. Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2018 Jan 20;391(10117):205-218. doi: 10.1016/S0140-6736(17)32458-3. Epub 2017 Nov 10.
PubMed 29132879Eikelboom JW, Connolly SJ, Bosch J, Dagenais GR, Hart RG, Shestakovska O, Diaz R, Alings M, Lonn EM, Anand SS, Widimsky P, Hori M, Avezum A, Piegas LS, Branch KRH, Probstfield J, Bhatt DL, Zhu J, Liang Y, Maggioni AP, Lopez-Jaramillo P, O'Donnell M, Kakkar AK, Fox KAA, Parkhomenko AN, Ertl G, Stork S, Keltai M, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Tonkin AM, Lewis BS, Felix C, Yusoff K, Steg PG, Metsarinne KP, Cook Bruns N, Misselwitz F, Chen E, Leong D, Yusuf S; COMPASS Investigators. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease. N Engl J Med. 2017 Oct 5;377(14):1319-1330. doi: 10.1056/NEJMoa1709118. Epub 2017 Aug 27.
PubMed 28844192Bosch J, Eikelboom JW, Connolly SJ, Bruns NC, Lanius V, Yuan F, Misselwitz F, Chen E, Diaz R, Alings M, Lonn EM, Widimsky P, Hori M, Avezum A, Piegas LS, Bhatt DL, Branch KRH, Probstfield JL, Liang Y, Liu L, Zhu J, Maggioni AP, Lopez-Jaramillo P, O'Donnell M, Fox KAA, Kakkar A, Parkhomenko AN, Ertl G, Stork S, Keltai K, Keltai M, Ryden L, Dagenais GR, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Ha JW, Tonkin AM, Varigos JD, Lewis BS, Felix C, Yusoff K, Steg PG, Aboyans V, Metsarinne KP, Anand SS, Hart RG, Lamy A, Moayyedi P, Leong DP, Sharma M, Yusuf S. Rationale, Design and Baseline Characteristics of Participants in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) Trial. Can J Cardiol. 2017 Aug;33(8):1027-1035. doi: 10.1016/j.cjca.2017.06.001. Epub 2017 Jun 8.
PubMed 28754388Braunwald E. An Important Step for Thrombocardiology. N Engl J Med. 2017 Oct 5;377(14):1387-1388. doi: 10.1056/NEJMe1710241. Epub 2017 Aug 27. No abstract available.
PubMed 28844176Fauchier L, Bisson A, Angoulvant D. Rivaroxaban in Stable Cardiovascular Disease. N Engl J Med. 2018 Jan 26;378(4):395. doi: 10.1056/NEJMc1714934. No abstract available.
PubMed 29372976Berger JS. Antithrombotic therapy in peripheral artery disease. Lancet. 2018 Jan 20;391(10117):183-184. doi: 10.1016/S0140-6736(17)32847-7. Epub 2017 Nov 10. No abstract available.
PubMed 29132877Darmon A, Bhatt DL, Elbez Y, Aboyans V, Anand S, Bosch J, Branch KR, Connolly SJ, Dyal L, Eikelboom JW, Fox KAA, Keltai K, Probstfield J, Yusuf S, Abtan J, Sorbets E, Eagle KA, Ducrocq G, Steg PG. External applicability of the COMPASS trial: an analysis of the reduction of atherothrombosis for continued health (REACH) registry. Eur Heart J. 2018 Mar 1;39(9):750-757a. doi: 10.1093/eurheartj/ehx658.
PubMed 29186454Verheugt FWA. Return of Oral Anticoagulation in Chronic Stable Coronary Disease. Circulation. 2018 Apr 17;137(16):1655-1657. doi: 10.1161/CIRCULATIONAHA.117.032916. No abstract available.
PubMed 29661947Fox KAA, Eikelboom JW, Anand SS, Bhatt DL, Bosch J, Connolly SJ, Harrington RA, Steg PG, Yusuf S. Anti-thrombotic options for secondary prevention in patients with chronic atherosclerotic vascular disease: what does COMPASS add? Eur Heart J. 2019 May 7;40(18):1466-1471. doi: 10.1093/eurheartj/ehy347. No abstract available.
PubMed 29945212Sharma M, Hart RG, Smith EE, Bosch J, Yuan F, Casanova A, Eikelboom JW, Connolly SJ, Wong G, Diaz R, Lopez-Jaramillo P, Ertl G, Stork S, Dagenais GR, Lonn EM, Ryden L, Tonkin AM, Varigos JD, Bhatt DL, Branch KR, Probstfield JL, Kim JH, Ha JW, O'Donnell M, Vinereanu D, Fox KA, Liang Y, Liu L, Zhu J, Pogosova N, Maggioni AP, Avezum A, Piegas LS, Keltai K, Keltai M, Cook Bruns N, Berkowitz S, Yusuf S. Rationale, design, and baseline participant characteristics in the MRI and cognitive substudy of the cardiovascular outcomes for people using anticoagulation strategies trial. Int J Stroke. 2019 Apr;14(3):270-281. doi: 10.1177/1747493018784478. Epub 2018 Jul 30.
PubMed 30058959Kruger PC, Eikelboom JW, Yusuf S. Rivaroxaban with or without aspirin for prevention of cardiovascular disease. Coron Artery Dis. 2018 Aug;29(5):361-365. doi: 10.1097/MCA.0000000000000605. No abstract available.
PubMed 29346127Ademi Z, Zomer E, Tonkin A, Liew D. Cost-effectiveness of rivaroxaban and aspirin compared to aspirin alone in patients with stable cardiovascular disease: An Australian perspective. Int J Cardiol. 2018 Nov 1;270:54-59. doi: 10.1016/j.ijcard.2018.06.091. Epub 2018 Jun 25.
PubMed 30220379