Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
NCT ID: NCT01776424
Last Updated: 2022-11-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
27395 participants
INTERVENTIONAL
2013-02-28
2021-06-15
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Rivaroxaban 2.5mg + Aspirin 100mg
Participants received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
Rivaroxaban (Xarelto, BAY59-7939)
Tablet, 2.5 mg, twice daily, oral
Aspirin
Tablet, 100 mg, once daily, oral
Pantoprazole
Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole
Pantoprazole placebo
Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo
Rivaroxaban 5mg + Aspirin Placebo
Participants received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
Rivaroxaban (Xarelto, BAY59-7939)
Tablet, 5 mg, twice daily, oral
Aspirin placebo
Aspirin matching placebo, once daily, oral
Pantoprazole
Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole
Pantoprazole placebo
Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo
Rivaroxaban Placebo + Aspirin 100mg
Participants received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
Aspirin
Tablet, 100 mg, once daily, oral
Rivaroxaban placebo
Rivaroxaban matching placebo, twice daily, oral
Pantoprazole
Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole
Pantoprazole placebo
Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo
Interventions
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Rivaroxaban (Xarelto, BAY59-7939)
Tablet, 2.5 mg, twice daily, oral
Rivaroxaban (Xarelto, BAY59-7939)
Tablet, 5 mg, twice daily, oral
Aspirin
Tablet, 100 mg, once daily, oral
Aspirin placebo
Aspirin matching placebo, once daily, oral
Rivaroxaban placebo
Rivaroxaban matching placebo, twice daily, oral
Pantoprazole
Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole
Pantoprazole placebo
Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo
Eligibility Criteria
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Inclusion Criteria
Subjects with CAD must also meet at least one of the following criteria:
* Age ≥65, or
* Age \<65 and documented atherosclerosis or revascularization involving at least 2 vascular beds, or at least 2 additional risk factors
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Population Health Research Institute
OTHER
Janssen Research & Development, LLC
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, Alabama, United States
Mobile, Alabama, United States
Anaheim, California, United States
Laguna Hills, California, United States
Northridge, California, United States
Palo Alto, California, United States
Santa Rosa, California, United States
Sylmar, California, United States
Torrance, California, United States
Norwalk, Connecticut, United States
Stamford, Connecticut, United States
Trumbull, Connecticut, United States
Atlantis, Florida, United States
Clearwater, Florida, United States
Coral Springs, Florida, United States
Jacksonville Beach, Florida, United States
Largo, Florida, United States
New Port Richey, Florida, United States
Safety Harbor, Florida, United States
Sarasota, Florida, United States
Meridian, Idaho, United States
Arlington Heights, Illinois, United States
Hazel Crest, Illinois, United States
Davenport, Iowa, United States
West Des Moines, Iowa, United States
Crestview Hills, Kentucky, United States
Baltimore, Maryland, United States
Haverhill, Massachusetts, United States
Alpena, Michigan, United States
Jackson, Michigan, United States
St Louis, Missouri, United States
Kalispell, Montana, United States
New Brunswick, New Jersey, United States
Cortlandt Manor, New York, United States
Kingston, New York, United States
Saratoga Springs, New York, United States
Durham, North Carolina, United States
Pinehurst, North Carolina, United States
Elyria, Ohio, United States
Sandusky, Ohio, United States
Toledo, Ohio, United States
Doylestown, Pennsylvania, United States
Langhorne, Pennsylvania, United States
Yardley, Pennsylvania, United States
Sioux Falls, South Dakota, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Bellevue, Washington, United States
Puyallup, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Adrogué, Buenos Aires, Argentina
Bahía Blanca, Buenos Aires, Argentina
Coronel Suárez, Buenos Aires, Argentina
Junín, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
Mar del Plata, Buenos Aires, Argentina
Merlo, Buenos Aires, Argentina
Munro, Buenos Aires, Argentina
Quilmes, Buenos Aires, Argentina
Ramos Mejía, Buenos Aires, Argentina
San Martín, Buenos Aires, Argentina
San Nicolás de los Arroyos, Buenos Aires, Argentina
Vicente López, Buenos Aires, Argentina
Zárate, Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Ciudad Autón. de Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Villa Allende, Córdoba Province, Argentina
Villa María, Córdoba Province, Argentina
Santa Rosa, La Pampa Province, Argentina
Rafaela, Santa Fe Province, Argentina
Rosario, Santa Fe Province, Argentina
Rosario, Santa Fe Province, Argentina
Rosario, Santa Fe Province, Argentina
Venado Tuerto, Santa Fe Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
Ciudad Auton. de Buenos Aires, , Argentina
Ciudad Auton. de Buenos Aires, , Argentina
Ciudad Auton. de Buenos Aires, , Argentina
Corrientes, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Salta, , Argentina
San Juan, , Argentina
San Luis, , Argentina
Santa Fe, , Argentina
Bruce, Australian Capital Territory, Australia
Gosford, New South Wales, Australia
New Lambton Heights, New South Wales, Australia
Taree, New South Wales, Australia
Birtinya, Queensland, Australia
Brisbane, Queensland, Australia
Brisbane, Queensland, Australia
Redcliffe, Queensland, Australia
Woolloongabba, Queensland, Australia
Adelaide, South Australia, Australia
Hobart, Tasmania, Australia
Launceston, Tasmania, Australia
Geelong, Victoria, Australia
Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Prahran, Victoria, Australia
Murdoch, Western Australia, Australia
Nedlands, Western Australia, Australia
Antwerp, , Belgium
Bonheiden, , Belgium
Bruges, , Belgium
Bruxelles - Brussel, , Belgium
Charleroi, , Belgium
Genk, , Belgium
Hasselt, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Liège, , Belgium
Roeselare, , Belgium
Goiânia, Goiás, Brazil
Belo Horizonte, Minas Gerais, Brazil
Uberaba, Minas Gerais, Brazil
Uberlândia, Minas Gerais, Brazil
Campina Grande do Sul, Paraná, Brazil
Curitiba, Paraná, Brazil
Canoas, Rio Grande do Sul, Brazil
Pelotas, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Blumenau, Santa Catarina, Brazil
Campinas, São Paulo, Brazil
Campinas, São Paulo, Brazil
Campinas, São Paulo, Brazil
Matão, São Paulo, Brazil
São José do Rio Preto, São Paulo, Brazil
São José do Rio Preto, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Votuporanga, São Paulo, Brazil
São Paulo, , Brazil
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
New Westminster, British Columbia, Canada
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
Winnipeg, Manitoba, Canada
Winnipeg, Manitoba, Canada
Winnipeg, Manitoba, Canada
Moncton, New Brunswick, Canada
Saint John, New Brunswick, Canada
Halifax, Nova Scotia, Canada
Brampton, Ontario, Canada
Burlington, Ontario, Canada
Burlington, Ontario, Canada
Cambridge, Ontario, Canada
Cambridge, Ontario, Canada
Greater Sudbury, Ontario, Canada
Greater Sudbury, Ontario, Canada
Grimsby, Ontario, Canada
Hamilton, Ontario, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Newmarket, Ontario, Canada
Newmarket, Ontario, Canada
Oakville, Ontario, Canada
Oshawa, Ontario, Canada
Oshawa, Ontario, Canada
Ottawa, Ontario, Canada
Peterborough, Ontario, Canada
Scarborough Village, Ontario, Canada
Toronto, Ontario, Canada
Waterloo, Ontario, Canada
Windsor, Ontario, Canada
Chicoutimi, Quebec, Canada
Laval, Quebec, Canada
Lévis, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Sherbrooke, Quebec, Canada
Terrebonne, Quebec, Canada
Thetford-Mines, Quebec, Canada
Trois-Rivières, Quebec, Canada
Ontario, , Canada
Québec, , Canada
Concepción, Bío-Bío, Chile
Osorno, Los Lagos Region, Chile
Valdivia, Los Lagos Region, Chile
Temuco, Región de la Araucanía, Chile
Temuco, Región de la Araucanía, Chile
Temuco, Región de la Araucanía, Chile
Viña del Mar, Región de Valparaíso, Chile
Providencia, Santiago Metropolitan, Chile
San Miguel, Santiago Metropolitan, Chile
Santiago, , Chile
Santiago, , Chile
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Wudan, Hubei, China
Wuhan, Hubei, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Changchun, Jilin, China
Changchun, Jilin, China
Shenyang, Liaoning, China
Xi’an, Shanxi, China
Chengdu, Sichuan, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Wenzhou, Zhejiang, China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Barranquilla, Atlántico, Colombia
Manizales, Caldas Department, Colombia
Cartagena, Departamento de Bolívar, Colombia
Montería, Departamento de Córdoba, Colombia
Pasto, Departamento de Nariño, Colombia
Armenia, Quindío Department, Colombia
Pereira, Risaralda Department, Colombia
Bucaramanga, Santander Department, Colombia
Floridablanca, Santander Department, Colombia
Espinal, Tolima Department, Colombia
Cali, Valle del Cauca Department, Colombia
Barranquilla, , Colombia
Bogotá, , Colombia
Brno, , Czechia
Brno, , Czechia
České Budějovice, , Czechia
Český Krumlov, , Czechia
Hodonín, , Czechia
Hradec Králové, , Czechia
Jablonec nad Nisou, , Czechia
Kolín, , Czechia
Liberec, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Ostrava, , Czechia
Pardubice, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Slaný, , Czechia
Sušice, , Czechia
Třebíč, , Czechia
Třinec, , Czechia
Uherské Hradiště, , Czechia
Zlín, , Czechia
Aalborg, , Denmark
Aarhus N, , Denmark
Copenhagen, , Denmark
Hellerup, , Denmark
Holbæk, , Denmark
Hvidovre, , Denmark
Kolding, , Denmark
København Ø, , Denmark
Viborg, , Denmark
Guayaquil, Guayas, Ecuador
Quito, Pichincha, Ecuador
Quito, , Ecuador
Kuopio, , Finland
Kuusankoski, , Finland
Tampere, , Finland
Turku, , Finland
Vantaa, , Finland
Amiens, , France
Clermont-Ferrand, , France
Limoges, , France
Montpellier, , France
Nice, , France
Nîmes, , France
Paris, , France
Paris, , France
Paris, , France
Saint-Priest-en-Jarez, , France
Nuremberg, Bavaria, Germany
Würzburg, Bavaria, Germany
Bad Homburg, Hesse, Germany
Frankfurt am Main, Hesse, Germany
Kassel, Hesse, Germany
Bielefeld, North Rhine-Westphalia, Germany
Dortmund, North Rhine-Westphalia, Germany
Wuppertal, North Rhine-Westphalia, Germany
Dresden, Saxony, Germany
Leipzig, Saxony, Germany
Magdeburg, Saxony-Anhalt, Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Bottrop, , Germany
Frankfurt, , Germany
Hamburg, , Germany
Warendorf, , Germany
Balatonfüred, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Mosonmagyaróvár, , Hungary
Pécs, , Hungary
Sopron, , Hungary
Szekszárd, , Hungary
Székesfehérvár, , Hungary
Ballinasloe, Co. Galway, Ireland
Cork, , Ireland
Dublin, , Ireland
Dublin, , Ireland
Dublin, , Ireland
Galway, , Ireland
Afula, , Israel
Ashkelon, , Israel
Bnei Brak, , Israel
Haifa, , Israel
Haifa, , Israel
Holon, , Israel
Nahariya, , Israel
Safed, , Israel
Tel Aviv, , Israel
Tel Aviv, , Israel
Foggia, Apulia, Italy
Lecce, Apulia, Italy
Caserta, Campania, Italy
Bologna, Emilia-Romagna, Italy
Forlì Cesena, Emilia-Romagna, Italy
Ravenna, Emilia-Romagna, Italy
Trieste, Friuli Venezia Giulia, Italy
Udine, Friuli Venezia Giulia, Italy
Udine, Friuli Venezia Giulia, Italy
Udine, Friuli Venezia Giulia, Italy
Brescia, Lombardy, Italy
Cremona, Lombardy, Italy
Pavia, Lombardy, Italy
Isernia, Molise, Italy
Catania, Sicily, Italy
Palermo, Sicily, Italy
Ancona, The Marches, Italy
Arezzo, Tuscany, Italy
Florence, Tuscany, Italy
Perugia, Umbria, Italy
Terni, Umbria, Italy
Nagoya, Aichi-ken, Japan
Toyoake, Aichi-ken, Japan
Kisarazu, Chiba, Japan
Matsudo, Chiba, Japan
Imabari, Ehime, Japan
Matsuyama, Ehime, Japan
Kasuga, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Miyako-gun, Fukuoka, Japan
Onga-gun, Fukuoka, Japan
Maebashi, Gunma, Japan
Onomichi, Hiroshima, Japan
Asahikawa, Hokkaido, Japan
Asahikawa, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Tomakomai, Hokkaido, Japan
Kobe, Hyōgo, Japan
Takarazuka, Hyōgo, Japan
Kaga, Ishikawa-ken, Japan
Miura-gun, Kanagawa, Japan
Sagamihara, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Naha, Okinawa, Japan
Kishiwada, Osaka, Japan
Takatsuki, Osaka, Japan
Tokorozawa, Saitama, Japan
Komatsushimachō, Tokushima, Japan
Akishima, Tokyo, Japan
Bunkyo-ku, Tokyo, Japan
Itabashi-ku, Tokyo, Japan
Shimonoseki, Yamaguchi, Japan
Chiba, , Japan
Fukuoka, , Japan
Fukuoka, , Japan
Gifu, , Japan
Gifu, , Japan
Kumamoto, , Japan
Kyoto, , Japan
Kyoto, , Japan
Kyoto, , Japan
Osaka, , Japan
Osaka, , Japan
Osaka, , Japan
Osaka, , Japan
Osaka, , Japan
Osaka, , Japan
Batu Caves, Selangor, , Malaysia
Kedah, , Malaysia
Kuala Lumpur, , Malaysia
Kuala Lumpur, , Malaysia
Kuala Selangor, , Malaysia
Sungai Buloh Selangor, , Malaysia
's-Hertogenbosch, , Netherlands
Amsterdam, , Netherlands
Apeldoorn, , Netherlands
Arnhem, , Netherlands
Breda, , Netherlands
Delft, , Netherlands
Deventer, , Netherlands
Doetinchem, , Netherlands
Drachten, , Netherlands
Ede, , Netherlands
Gorinchem, , Netherlands
Gouda, , Netherlands
Groningen, , Netherlands
Heerlen, , Netherlands
Helmond, , Netherlands
Hoogeveen, , Netherlands
Hoorn, , Netherlands
Leeuwarden, , Netherlands
Meppel, , Netherlands
Nijmegen, , Netherlands
Roermond, , Netherlands
Roosendaal, , Netherlands
Rotterdam, , Netherlands
Rotterdam, , Netherlands
Sneek, , Netherlands
Tiel, , Netherlands
Zwolle, , Netherlands
Batangas, , Philippines
Cebu City, , Philippines
City of Muntinlupa, , Philippines
Dagupan, , Philippines
Dasmariñas, , Philippines
Iloilo City, , Philippines
Laoag, , Philippines
Manila, , Philippines
Manila, , Philippines
Metro Manila, , Philippines
Palawan, , Philippines
Pasig, , Philippines
Quezon City, , Philippines
Quezon City, , Philippines
Quezon City, , Philippines
Tacloban City, , Philippines
Gdansk, , Poland
Kielce, , Poland
Krakow, , Poland
Krakow, , Poland
Krakow, , Poland
Krakow, , Poland
Lodz, , Poland
Tarnów, , Poland
Wroclaw, , Poland
Timișoara, Timiș County, Romania
Brasov, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Iași, , Romania
Iași, , Romania
Târgu Mureş, , Romania
Târgu Mureş, , Romania
Timișoara, , Romania
Barnaul, , Russia
Kemerovo, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Tomsk, , Russia
Zhukovskiy, , Russia
Bratislava, , Slovakia
Bratislava, , Slovakia
Košice, , Slovakia
Nitra, , Slovakia
Prešov, , Slovakia
Vráble, , Slovakia
Pinelands, Eastern Cape, South Africa
Port Elizabeth, Eastern Cape, South Africa
Bloemfontein, Freestate, South Africa
Johannesburg, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Observatory, Western Cape, South Africa
Pinelands, Western Cape, South Africa
Worcester, Western Cape, South Africa
Somerset West, , South Africa
Wŏnju, Gang''weondo, South Korea
Goyang-si, Gyeonggido, South Korea
Seongnam-si, Gyeonggido, South Korea
Jeju City, Jeju-do, South Korea
Seoul, Seoul Teugbyeolsi, South Korea
Busan, , South Korea
Daejeon, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Gothenburg, , Sweden
Helsingborg, , Sweden
Kristianstad, , Sweden
Örebro, , Sweden
Östersund, , Sweden
Skellefteå, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Vällingby, , Sweden
Lugano, Canton Ticino, Switzerland
Dnipropetrovsk, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Lviv, , Ukraine
Lviv, , Ukraine
Lviv, , Ukraine
Simferopol, , Ukraine
Vinnitsa, , Ukraine
Zaporizhzhya, , Ukraine
Zaporizhzhya, , Ukraine
Belfast, Antrim, United Kingdom
Londonderry Co. Londonderry, Derry, United Kingdom
Basildon, Essex, United Kingdom
Stevenage, Hertfordshire, United Kingdom
Blackpool, Lancashire, United Kingdom
Harrow, London, United Kingdom
Portadown, North Ireland, United Kingdom
Middlesbrough, North Yorkshire, United Kingdom
Northampton, Northamptonshire, United Kingdom
Hardwick, Stockton-on-Tees, United Kingdom
Nuneaton, Warwickshire, United Kingdom
West Bromich, West Midlands, United Kingdom
Wolverhampton, West Midlands, United Kingdom
Worcester, Worcestershire, United Kingdom
Countries
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References
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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.
Anand 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.
Anand SS, Bosch J, Eikelboom JW, Connolly SJ, Diaz R, Widimsky P, Aboyans V, Alings M, Kakkar AK, Keltai K, Maggioni AP, Lewis BS, Störk 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. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 Nov 10. pii: S0140-6736(17)32409-1. doi: 10.1016/S0140-6736(17)32409-1. PMID:29132880
Connolly 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. Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 Nov 10. pii: S0140-6736(17)32458-3. doi: 10.1016/S0140-6736(17)32458-3. PMID:29132879
Eikelboom 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.
Bosch 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.
Braunwald 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.
Fauchier 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.
Berger 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.
Darmon 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.
Verheugt 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.
Fox 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.
Sharma 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.
Kruger 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.
Ademi 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.
Bhagirath VC, Eikelboom JW, Anand SS. Low-dose rivaroxaban plus aspirin for the prevention of cardiovascular events: an evaluation of COMPASS. Future Cardiol. 2018 Nov;14(6):443-453. doi: 10.2217/fca-2018-0059. Epub 2018 Nov 12.
Kruger PC, Anand SS, de Vries TAC, Eikelboom JW. Patients with Peripheral Artery Disease in the COMPASS Trial. Eur J Vasc Endovasc Surg. 2018 Dec;56(6):772-773. doi: 10.1016/j.ejvs.2018.08.010. Epub 2018 Sep 10. No abstract available.
Boden WE, Bhatt DL. Will COMPASS Point to a New Direction in Thrombotic Risk Reduction in Patients With Stable Cardiovascular Disease? Circulation. 2018 Aug 28;138(9):858-860. doi: 10.1161/CIRCULATIONAHA.118.035405. No abstract available.
Lamy A, Eikelboom J, Sheth T, Connolly S, Bosch J, Fox KAA, Zhu J, Lonn E, Dagenais G, Widimsky P, Branch KRH, Bhatt DL, Zheng Z, Straka Z, Dagenais F, Kong Y, Marsden T, Lee SF, Copland I, Yusuf S. Rivaroxaban, Aspirin, or Both to Prevent Early Coronary Bypass Graft Occlusion: The COMPASS-CABG Study. J Am Coll Cardiol. 2019 Jan 22;73(2):121-130. doi: 10.1016/j.jacc.2018.10.048.
Sharma M, Hart RG, Connolly SJ, Bosch J, Shestakovska O, Ng KKH, Catanese L, Keltai K, Aboyans V, Alings M, Ha JW, Varigos J, Tonkin A, O'Donnell M, Bhatt DL, Fox K, Maggioni A, Berkowitz SD, Bruns NC, Yusuf S, Eikelboom JW. Stroke Outcomes in the COMPASS Trial. Circulation. 2019 Feb 26;139(9):1134-1145. doi: 10.1161/CIRCULATIONAHA.118.035864.
Coppens M, Weitz JI, Eikelboom JWA. Synergy of Dual Pathway Inhibition in Chronic Cardiovascular Disease. Circ Res. 2019 Feb;124(3):416-425. doi: 10.1161/CIRCRESAHA.118.313141.
Moayyedi P, Eikelboom JW, Bosch J, Connolly SJ, Dyal L, Shestakovska O, Leong D, Anand SS, Stork S, Branch KRH, Bhatt DL, Verhamme PB, O'Donnell M, Maggioni AP, Lonn EM, Piegas LS, Ertl G, Keltai M, Cook Bruns N, Muehlhofer E, Dagenais GR, Kim JH, Hori M, Steg PG, Hart RG, Diaz R, Alings M, Widimsky P, Avezum A, Probstfield J, Zhu J, Liang Y, Lopez-Jaramillo P, Kakkar A, Parkhomenko AN, Ryden L, Pogosova N, Dans A, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik T, Vinereanu D, Tonkin AM, Lewis BS, Felix C, Yusoff K, Metsarinne K, Fox KAA, Yusuf S; COMPASS Investigators. Pantoprazole to Prevent Gastroduodenal Events in Patients Receiving Rivaroxaban and/or Aspirin in a Randomized, Double-Blind, Placebo-Controlled Trial. Gastroenterology. 2019 Aug;157(2):403-412.e5. doi: 10.1053/j.gastro.2019.04.041. Epub 2019 May 2.
Fox KAA, Eikelboom JW, Shestakovska O, Connolly SJ, Metsarinne KP, Yusuf S. Rivaroxaban Plus Aspirin in Patients With Vascular Disease and Renal Dysfunction: From the COMPASS Trial. J Am Coll Cardiol. 2019 May 14;73(18):2243-2250. doi: 10.1016/j.jacc.2019.02.048.
Cairns JA, Eikelboom JW, Shestakovska O, Yusuf S, DeMets D. Monitoring Emerging Data From the COMPASS Trial of an Antithrombotic Agent. J Am Coll Cardiol. 2019 Jun 4;73(21):2769-2772. doi: 10.1016/j.jacc.2019.03.479. No abstract available.
Moayyedi P, Eikelboom JW, Bosch J, Connolly SJ, Dyal L, Shestakovska O, Leong D, Anand SS, Stork S, Branch KRH, Bhatt DL, Verhamme PB, O'Donnell M, Maggioni AP, Lonn EM, Piegas LS, Ertl G, Keltai M, Bruns NC, Muehlhofer E, Dagenais GR, Kim JH, Hori M, Steg PG, Hart RG, Diaz R, Alings M, Widimsky P, Avezum A, Probstfield J, Zhu J, Liang Y, Lopez-Jaramillo P, Kakkar AK, Parkhomenko AN, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Vinereanu D, Tonkin AM, Lewis BS, Felix C, Yusoff K, Metsarinne KP, Fox KAA, Yusuf S; COMPASS Investigators. Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin. Gastroenterology. 2019 Sep;157(3):682-691.e2. doi: 10.1053/j.gastro.2019.05.056. Epub 2019 May 29.
Kruger PC, Guzik TJ, Eikelboom JW. How can the results of the COMPASS trial benefit patients with coronary or peripheral artery disease in Poland? Kardiol Pol. 2019 Aug 23;77(7-8):661-669. doi: 10.33963/KP.14855. Epub 2019 May 30.
Branch KR, Probstfield JL, Eikelboom JW, Bosch J, Maggioni AP, Cheng RK, Bhatt DL, Avezum A, Fox KAA, Connolly SJ, Shestakovska O, Yusuf S. Rivaroxaban With or Without Aspirin in Patients With Heart Failure and Chronic Coronary or Peripheral Artery Disease. Circulation. 2019 Aug 13;140(7):529-537. doi: 10.1161/CIRCULATIONAHA.119.039609. Epub 2019 Jun 5.
Darmon A, Sorbets E, Ducrocq G, Elbez Y, Abtan J, Popovic B, Ohman EM, Rother J, Wilson PF, Montalescot G, Zeymer U, Bhatt DL, Steg PG; REACH Registry Investigators. Association of Multiple Enrichment Criteria With Ischemic and Bleeding Risks Among COMPASS-Eligible Patients. J Am Coll Cardiol. 2019 Jul 2;73(25):3281-3291. doi: 10.1016/j.jacc.2019.04.046.
Anand SS, Eikelboom JW, Dyal L, Bosch J, Neumann C, Widimsky P, Avezum AA, Probstfield J, Cook Bruns N, Fox KAA, Bhatt DL, Connolly SJ, Yusuf S; COMPASS Trial Investigators. Rivaroxaban Plus Aspirin Versus Aspirin in Relation to Vascular Risk in the COMPASS Trial. J Am Coll Cardiol. 2019 Jul 2;73(25):3271-3280. doi: 10.1016/j.jacc.2019.02.079.
Fox KAA, Metra M, Morais J, Atar D. The myth of 'stable' coronary artery disease. Nat Rev Cardiol. 2020 Jan;17(1):9-21. doi: 10.1038/s41569-019-0233-y. Epub 2019 Jul 29.
de Vries TI, Eikelboom JW, Bosch J, Westerink J, Dorresteijn JAN, Alings M, Dyal L, Berkowitz SD, van der Graaf Y, Fox KAA, Visseren FLJ. Estimating individual lifetime benefit and bleeding risk of adding rivaroxaban to aspirin for patients with stable cardiovascular disease: results from the COMPASS trial. Eur Heart J. 2019 Dec 7;40(46):3771-3778a. doi: 10.1093/eurheartj/ehz404.
Eikelboom JW, Connolly SJ, Bosch J, Shestakovska O, Aboyans V, Alings M, Anand SS, Avezum A, Berkowitz SD, Bhatt DL, Cook-Bruns N, Felix C, Fox KAA, Hart RG, Maggioni AP, Moayyedi P, O'Donnell M, Ryden L, Verhamme P, Widimsky P, Zhu J, Yusuf S. Bleeding and New Cancer Diagnosis in Patients With Atherosclerosis. Circulation. 2019 Oct 29;140(18):1451-1459. doi: 10.1161/CIRCULATIONAHA.119.041949. Epub 2019 Sep 12.
Perera KS, Ng KKH, Nayar S, Catanese L, Dyal L, Sharma M, Connolly SJ, Yusuf S, Bosch J, Eikelboom JW, Hart RG. Association Between Low-Dose Rivaroxaban With or Without Aspirin and Ischemic Stroke Subtypes: A Secondary Analysis of the COMPASS Trial. JAMA Neurol. 2020 Jan 1;77(1):43-48. doi: 10.1001/jamaneurol.2019.2984.
Eikelboom JW, Bosch JJ, Connolly SJ, Shestakovska O, Dagenais GR, Hart RG, Leong DP, O'Donnell M, Fox KAA, Bhatt DL, Cairns JA, Tasto C, Berkowitz SD, Cook Bruns N, Muehlhofer E, Diaz R, Maggioni AP, Yusuf S. Major Bleeding in Patients With Coronary or Peripheral Artery Disease Treated With Rivaroxaban Plus Aspirin. J Am Coll Cardiol. 2019 Sep 24;74(12):1519-1528. doi: 10.1016/j.jacc.2019.07.065.
Wurtz M, Olesen KKW, Thim T, Kristensen SD, Eikelboom JW, Maeng M. External applicability of the COMPASS trial: the Western Denmark Heart Registry. Eur Heart J Cardiovasc Pharmacother. 2019 Oct 1;5(4):192-199. doi: 10.1093/ehjcvp/pvz013.
Vanassche T, Verhamme P, Anand SS, Shestakovska O, Fox KA, Bhatt DL, Avezum A, Alings M, Aboyans V, Maggioni AP, Widimsky P, Berkowitz SD, Yusuf S, Connolly SJ, Eikelboom JW, Bosch J. Risk factors and clinical outcomes in chronic coronary and peripheral artery disease: An analysis of the randomized, double-blind COMPASS trial. Eur J Prev Cardiol. 2020 Feb;27(3):296-307. doi: 10.1177/2047487319882154. Epub 2019 Oct 15.
Cowie MR, Lamy A, Levy P, Mealing S, Millier A, Mernagh P, Cristeau O, Bowrin K, Briere JB. Health economic evaluation of rivaroxaban in the treatment of patients with chronic coronary artery disease or peripheral artery disease. Cardiovasc Res. 2020 Sep 1;116(11):1918-1924. doi: 10.1093/cvr/cvz278.
Welsh RC, Peterson ED, De Caterina R, Bode C, Gersh B, Eikelboom JW. Applying contemporary antithrombotic therapy in the secondary prevention of chronic atherosclerotic cardiovascular disease. Am Heart J. 2019 Dec;218:100-109. doi: 10.1016/j.ahj.2019.09.006. Epub 2019 Oct 23.
Schiele F, Puymirat E, Ferrieres J, Simon T, Fox KAA, Eikelboom J, Danchin N; FAST-MI investigators. The FAST-MI 2005-2010-2015 registries in the light of the COMPASS trial: The COMPASS criteria applied to a post-MI population. Int J Cardiol. 2019 Mar 1;278:7-13. doi: 10.1016/j.ijcard.2018.11.138. Epub 2018 Dec 3.
Bainey KR, Welsh RC, Connolly SJ, Marsden T, Bosch J, Fox KAA, Steg PG, Vinereanu D, Connolly DL, Berkowitz SD, Foody JM, Probstfield JL, Branch KR, Lewis BS, Diaz R, Muehlhofer E, Widimsky P, Yusuf S, Eikelboom JW, Bhatt DL; COMPASS Investigators. Rivaroxaban Plus Aspirin Versus Aspirin Alone in Patients With Prior Percutaneous Coronary Intervention (COMPASS-PCI). Circulation. 2020 Apr 7;141(14):1141-1151. doi: 10.1161/CIRCULATIONAHA.119.044598. Epub 2020 Mar 17.
Liang Y, Zhu J, Liu L, Anand SS, Connolly SJ, Bosch J, Guzik TJ, O'Donnell M, Dagenais GR, Fox KA, Shestakovska O, Berkowitz SD, Muehlhofer E, Keller L, Yusuf S, Eikelboom JW; COMPASS Investigators. Efficacy and safety of rivaroxaban plus aspirin in women and men with chronic coronary or peripheral artery disease. Cardiovasc Res. 2021 Feb 22;117(3):942-949. doi: 10.1093/cvr/cvaa100.
Bhatt DL, Eikelboom JW, Connolly SJ, Steg PG, Anand SS, Verma S, Branch KRH, Probstfield J, Bosch J, Shestakovska O, Szarek M, Maggioni AP, Widimsky P, Avezum A, Diaz R, Lewis BS, Berkowitz SD, Fox KAA, Ryden L, Yusuf S; COMPASS Steering Committee and Investigators. Role of Combination Antiplatelet and Anticoagulation Therapy in Diabetes Mellitus and Cardiovascular Disease: Insights From the COMPASS Trial. Circulation. 2020 Jun 9;141(23):1841-1854. doi: 10.1161/CIRCULATIONAHA.120.046448. Epub 2020 Mar 28.
Steffel J, Eikelboom JW, Anand SS, Shestakovska O, Yusuf S, Fox KAA. The COMPASS Trial: Net Clinical Benefit of Low-Dose Rivaroxaban Plus Aspirin as Compared With Aspirin in Patients With Chronic Vascular Disease. Circulation. 2020 Jul 7;142(1):40-48. doi: 10.1161/CIRCULATIONAHA.120.046048. Epub 2020 May 21.
Sharma M, Hart RG, Smith EE, Bosch J, Eikelboom JW, Connolly SJ, Dyal L, Reeh KW, Casanova A, Diaz R, Lopez-Jaramillo P, Ertl G, Stork S, Dagenais GR, Lonn EM, Ryden L, Tonkin AM, Varigos JD, Bhatt DL, Branch KRH, Probstfield JL, Kim JH, O'Donnell M, Vinereanu D, A A Fox K, Liang Y, Liu L, Zhu J, Pogosova N, Maggioni AP, Avezum A, Piegas LS, Keltai K, Keltai M, Berkowitz SD, Yusuf S. Rivaroxaban for Prevention of Covert Brain Infarcts and Cognitive Decline: The COMPASS MRI Substudy. Stroke. 2020 Oct;51(10):2901-2909. doi: 10.1161/STROKEAHA.120.029762. Epub 2020 Sep 21.
Kaplovitch E, Eikelboom JW, Dyal L, Aboyans V, Abola MT, Verhamme P, Avezum A, Fox KAA, Berkowitz SD, Bangdiwala SI, Yusuf S, Anand SS. Rivaroxaban and Aspirin in Patients With Symptomatic Lower Extremity Peripheral Artery Disease: A Subanalysis of the COMPASS Randomized Clinical Trial. JAMA Cardiol. 2021 Jan 1;6(1):21-29. doi: 10.1001/jamacardio.2020.4390.
Guzik TJ, Ramasundarahettige C, Pogosova N, Lopez-Jaramillo P, Dyal L, Berkowitz SD, Muehlhofer E, Bhatt DL, Fox KAA, Yusuf S, Eikelboom JW. Rivaroxaban Plus Aspirin in Obese and Overweight Patients With Vascular Disease in the COMPASS Trial. J Am Coll Cardiol. 2021 Feb 9;77(5):511-525. doi: 10.1016/j.jacc.2020.11.061.
Sen J, Tonkin A, Varigos J, Fonguh S, Berkowitz SD, Yusuf S, Verhamme P, Vanassche T, Anand SS, Fox KAA, Eikelboom JW, Amerena J; COMPASS Trial Investigators. Risk stratification of cardiovascular complications using CHA2DS2-VASc and CHADS2 scores in chronic atherosclerotic cardiovascular disease. Int J Cardiol. 2021 Aug 15;337:9-15. doi: 10.1016/j.ijcard.2021.04.067. Epub 2021 May 3.
Dagenais GR, Dyal L, Bosch JJ, Leong DP, Aboyans V, Berkowitz SD, Bhatt DL, Connolly SJ, Fox KAA, Muehlhofer E, Probstfield JL, Widimsky P, Winkelmann BR, Yusuf S, Eikelboom JW. Cardiovascular consequences of discontinuing low-dose rivaroxaban in people with chronic coronary or peripheral artery disease. Heart. 2021 Jul;107(14):1130-1137. doi: 10.1136/heartjnl-2020-318758. Epub 2021 May 21.
Lamy A, Browne A, Sheth T, Zheng Z, Dagenais F, Noiseux N, Chen X, Bakaeen FG, Brtko M, Stevens LM, Alboom M, Lee SF, Copland I, Salim Y, Eikelboom J; COMPASS Investigators. Skeletonized vs Pedicled Internal Mammary Artery Graft Harvesting in Coronary Artery Bypass Surgery: A Post Hoc Analysis From the COMPASS Trial. JAMA Cardiol. 2021 Sep 1;6(9):1042-1049. doi: 10.1001/jamacardio.2021.1686.
Vanassche T, Verhamme P, Anand SS, Shestakovska O, Leong DP, Fox KAA, Bhatt DL, Avezum A, Alings M, Aboyans V, Maggioni AP, Widimsky P, Muehlhofer E, Berkowitz SD, Yusuf S, Connolly SJ, Eikelboom JW, Bosch J. Low-dose rivaroxaban plus aspirin in patients with polypharmacy and multimorbidity: an analysis from the COMPASS trial. Eur Heart J Cardiovasc Pharmacother. 2022 Aug 11;8(5):462-473. doi: 10.1093/ehjcvp/pvab050.
Eikelboom JW, Bhatt DL, Fox KAA, Bosch J, Connolly SJ, Anand SS, Avezum A, Berkowitz SD, Branch KRH, Dagenais GR, Felix C, Guzik TJ, Hart RG, Maggioni AP, Muehlhofer E, Sharma M, Shestakovska O, Yusuf S. Mortality Benefit of Rivaroxaban Plus Aspirin in Patients With Chronic Coronary or Peripheral Artery Disease. J Am Coll Cardiol. 2021 Jul 6;78(1):14-23. doi: 10.1016/j.jacc.2021.04.083.
Anand SS, Hiatt W, Dyal L, Bauersachs R, Berkowitz SD, Branch KRH, Debus S, Fox KAA, Liang Y, Muehlhofer E, Nehler M, Haskell LP, Patel M, Szarek M, Yusuf S, Eikelboom J, Bonaca MP. Low-dose rivaroxaban and aspirin among patients with peripheral artery disease: a meta-analysis of the COMPASS and VOYAGER trials. Eur J Prev Cardiol. 2022 May 5;29(5):e181-e189. doi: 10.1093/eurjpc/zwab128.
Kaplovitch E, Anand SS. The evolving treatment of peripheral arterial disease: preventing ischaemic events in the post-COMPASS era. Cardiovasc Res. 2019 Oct 1;115(12):e121-e124. doi: 10.1093/cvr/cvz170. No abstract available.
Lee SF, Ramasundarahettige C, Gerstein HC, McIntyre WF, Eikelboom J, O'Donnell MJ, Zhou Y, Bangdiwala SI, Thabane L. Comparison of total event analysis and first event analysis in relation to heterogeneity in cardiovascular trials. BMC Med Res Methodol. 2025 Jun 9;25(1):159. doi: 10.1186/s12874-025-02593-3.
Xie F, Yan J, Eikelboom J, Anand S, Muehlhofer E, Pullenayegum E, Wang Y, Avezum A, Bhatt DL, Yusuf S, Bosch J. Health-related quality of life with rivaroxaban plus aspirin vs. aspirin alone in chronic stable cardiovascular disease: Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial. Eur Heart J Open. 2024 Sep 27;4(5):oeae083. doi: 10.1093/ehjopen/oeae083. eCollection 2024 Sep.
Eikelboom JW, Yi Q, McIntyre WF, Bosch J, Whitlock R, Connolly SJ, Scheier TC, Muehlhofer E, Pap AF, Pocock SJ, Bangdiwala SI. Results of the COMPASS Trial Analyzed Using Win Ratio Compared With Conventional Analytic Approaches. Can J Cardiol. 2024 Nov;40(11):2171-2179. doi: 10.1016/j.cjca.2024.07.002. Epub 2024 Jul 14.
Leong DP, Bosch J, Bhatt DL, Avezum A, Yuan F, Yusuf S, Eikelboom JW. Impact of Frailty on the Benefits of Dual Pathway Inhibition for the Secondary Prevention of Cardiovascular Events in the COMPASS Randomised Trial. Can J Cardiol. 2025 Jan;41(1):102-111. doi: 10.1016/j.cjca.2024.06.017. Epub 2024 Jun 22.
Pyne L, Smyth A, Molnar AO, Moayyedi P, Muehlhofer E, Yusuf S, Eikelboom J, Bosch J, Walsh M. The Effects of Pantoprazole on Kidney Outcomes: Post Hoc Observational Analysis from the COMPASS Trial. J Am Soc Nephrol. 2024 Jul 1;35(7):901-909. doi: 10.1681/ASN.0000000000000356. Epub 2024 Apr 11.
Lamy A, Eikelboom J, Tong W, Yuan F, Bangdiwala SI, Bosch J, Connolly S, Lonn E, Dagenais GR, Branch KRH, Wang WJ, Bhatt DL, Probstfield J, Ertl G, Stork S, Steg PG, Aboyans V, Durand-Zaleski I, Ryden L, Yusuf S; COMPASS Investigators. The Cost-Effectiveness of Rivaroxaban Plus Aspirin Compared with Aspirin Alone in the COMPASS Trial: A US Perspective. Am J Cardiovasc Drugs. 2024 Jan;24(1):117-127. doi: 10.1007/s40256-023-00620-6. Epub 2023 Dec 28.
Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.
Branch KRH, Probstfield JL, Bosch J, Bhatt DL, Maggioni AP, Muehlhofer E, Avezum A, Widimsky P, Connolly SJ, Yi Q, Shestakovska O, Yusuf S, Eikelboom JW. Total events and net clinical benefit of rivaroxaban and aspirin in patients with chronic coronary or peripheral artery disease: The COMPASS trial. Am Heart J. 2023 Apr;258:60-68. doi: 10.1016/j.ahj.2023.01.008. Epub 2023 Jan 14.
Smolderen KG, Mena-Hurtado C, Eikelboom JW, Bosch J, Xie F, Ramasundarahettige C, Bhatt DL, Anand SS. Health status and cognitive function for risk stratification in chronic coronary and peripheral artery disease. Eur J Prev Cardiol. 2023 May 9;30(7):535-545. doi: 10.1093/eurjpc/zwac282.
Gaba P, Bhatt DL, Dagenais GR, Bosch J, Maggioni AP, Widimsky P, Leong D, Fox KAA, Yusuf S, Eikelboom JW; COMPASS Steering Committee and Investigators. Comparison of Investigator-Reported vs Centrally Adjudicated Major Adverse Cardiac Events: A Secondary Analysis of the COMPASS Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2243201. doi: 10.1001/jamanetworkopen.2022.43201.
Lamy A, Eikelboom J, Tong W, Yuan F, Bangdiwala SI, Bosch J, Connolly S, Lonn E, Dagenais GR, Branch KRH, Wang WJ, Bhatt DL, Probstfield J, Ertl G, Stork S, Steg PG, Aboyans V, Durand-Zaleski I, Ryden L, Yusuf S. The cost-effectiveness of rivaroxaban with or without aspirin in the COMPASS trial. Eur Heart J Qual Care Clin Outcomes. 2023 Aug 7;9(5):502-510. doi: 10.1093/ehjqcco/qcac054.
Alboom M, Browne A, Sheth T, Zheng Z, Dagenais F, Noiseux N, Brtko M, Stevens LM, Lee SF, Copland I, Power P, Eikelboom J, Lamy A. Conduit selection and early graft failure in coronary artery bypass surgery: A post hoc analysis of the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) coronary artery bypass grafting study. J Thorac Cardiovasc Surg. 2023 Mar;165(3):1080-1089.e1. doi: 10.1016/j.jtcvs.2022.05.028. Epub 2022 Jun 2.
Catanese L, Eikelboom JW, Bosch J, Shestakovska O, Ng K, Nayar S, Perera KS, Shoamanesh A, Sharma M, Hart RG. Oral factor Xa inhibitors and risk of subdural hematoma: COMPASS trial results and meta-analysis. Neurology. 2020 Aug 4;95(5):e480-e487. doi: 10.1212/WNL.0000000000009826. Epub 2020 Jul 10.
Anand 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.
Connolly 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
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Other Identifiers
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2012-004180-43
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15786
Identifier Type: -
Identifier Source: org_study_id
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