An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome
NCT ID: NCT00809965
Last Updated: 2014-09-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
15526 participants
INTERVENTIONAL
2008-11-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rivaroxaban 2.5 mg bid
One 2.5 mg rivaroxaban tablet twice daily for up to 6 months
Rivaroxaban 2.5 mg
One tablet twice daily
Standard of care
Rivaroxaban 5 mg bid
One 5 mg rivaroxaban tablet twice daily for up to 6 months
Rivaroxaban 5 mg
One tablet twice daily
Standard of care
Placebo
One placebo tablet twice daily for up to 6 months
Placebo
One placebo tablet twice daily
Standard of care
Interventions
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Rivaroxaban 2.5 mg
One tablet twice daily
Rivaroxaban 5 mg
One tablet twice daily
Placebo
One placebo tablet twice daily
Standard of care
Eligibility Criteria
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Inclusion Criteria
* Have been hospitalized for symptoms suggestive of acute coronary syndrome that lasted at least 10 minutes at rest and occurred 48 hours or less before going to the hospital
Exclusion Criteria
* Need for continued anticoagulant therapy
* Significant renal impairment or known significant liver disease
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Locations
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Birmingham, Alabama, United States
Geneva, Alabama, United States
Mobile, Alabama, United States
Anaheim, California, United States
Burbank, California, United States
Los Angeles, California, United States
Mission Hills, California, United States
San Diego, California, United States
Aurora, Colorado, United States
Littleton, Colorado, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Kissimmee, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Ormond Beach, Florida, United States
St. Petersburg, Florida, United States
Columbus, Georgia, United States
Rome, Georgia, United States
Aurora, Illinois, United States
Indianapolis, Indiana, United States
Merrillville, Indiana, United States
Munster, Indiana, United States
Valparaiso, Indiana, United States
Overland Park, Kansas, United States
Wichita, Kansas, United States
Lacombe, Louisiana, United States
Bethesda, Maryland, United States
Boston, Massachusetts, United States
Flint, Michigan, United States
Grand Blanc, Michigan, United States
Grand Rapids, Michigan, United States
Kalamazoo, Michigan, United States
Mount Clemens, Michigan, United States
Petoskey, Michigan, United States
Tupelo, Mississippi, United States
St Louis, Missouri, United States
Kalispell, Montana, United States
Bridgewater, New Jersey, United States
Linden, New Jersey, United States
Buffalo, New York, United States
Cortlandt Manor, New York, United States
Saratoga Springs, New York, United States
Stony Brook, New York, United States
Syracuse, New York, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Fairview Park, Ohio, United States
Bartlesville, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Doylestown, Pennsylvania, United States
Langhorne, Pennsylvania, United States
Ridley Park, Pennsylvania, United States
Sayre, Pennsylvania, United States
West Chester, Pennsylvania, United States
York, Pennsylvania, United States
Greenville, South Carolina, United States
Johnson City, Tennessee, United States
Memphis, Tennessee, United States
Amarillo, Texas, United States
Lubbock, Texas, United States
Odessa, Texas, United States
Tomball, Texas, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Danville, Virginia, United States
Roanoke, Virginia, United States
Spokane, Washington, United States
Wausau, Wisconsin, United States
Buenos Aires, , Argentina
Corrientes, , Argentina
Córdoba, , Argentina
Junín, , Argentina
La Plata, , Argentina
Mar del Plata, , Argentina
Morón, , Argentina
Resistencia, , Argentina
Rosario, , Argentina
Salta, , Argentina
San Luis, , Argentina
San Miguel de Tucumán, , Argentina
Santa Fe, , Argentina
Bedford Park, , Australia
Chermside, , Australia
Coffs Harbour South, , Australia
Douglas, , Australia
Epping, , Australia
Fremantle, , Australia
Heidelberg, , Australia
Herston, , Australia
Launceston, , Australia
Milton, , Australia
Newcastle, , Australia
Parkville, , Australia
Perth, , Australia
Southport, , Australia
Woolloongabba, , Australia
Bonheiden, , Belgium
Brussels, , Belgium
Eupen, , Belgium
Genk, , Belgium
Huy, , Belgium
Leuven, , Belgium
Mol, , Belgium
Tienen, , Belgium
Belo Horizonte, , Brazil
Blumenau, , Brazil
Campina Grande do Sul, , Brazil
Campinas, , Brazil
Curitiba, , Brazil
Porto Alegre, , Brazil
Recife, , Brazil
Ribeirão Preto, , Brazil
Rio de Janeiro, , Brazil
Salvador, , Brazil
São José do Rio Preto, , Brazil
São Paulo, , Brazil
Burgas, , Bulgaria
Dimitrovgrad, , Bulgaria
Haskovo, , Bulgaria
Pazardzhik, , Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Rousse, , Bulgaria
Sevlievo, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Veliko Tarnovo, , Bulgaria
Edmonton, Alberta, Canada
Kelowna, British Columbia, Canada
Maple Ridge, British Columbia, Canada
Victoria, British Columbia, Canada
St. John's, Newfoundland and Labrador, Canada
Greater Sudbury, Ontario, Canada
London, Ontario, Canada
Newmarket, Ontario, Canada
Oshawa, Ontario, Canada
Ottawa, Ontario, Canada
Granby, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Saint-Charles-Borromée, Quebec, Canada
Saint-Georges, Quebec, Canada
Sherbrooke, Quebec, Canada
Ste-Foy, Quebec, Canada
North Battleford, Saskatchewan, Canada
Laval, , Canada
Antofagasta, , Chile
Chile, , Chile
Osorno X Región, , Chile
Punta Arenas, , Chile
San Bernardo, , Chile
Santiago, , Chile
Santiago Rm, , Chile
Talcahuano, , Chile
Temuco, , Chile
Valdivia X Región, , Chile
Victoria, , Chile
Viña del Mar, , Chile
Beijing, , China
Beijing Prc, , China
Changsha, , China
Daqing, , China
Guangzhou, , China
Hangzhou, , China
Harbin, , China
Jinan, , China
Nanjing, , China
Shanghai, , China
Shenyang, , China
Tianjin, , China
Xi'an, , China
Armenia, , Colombia
Barranquilla, , Colombia
Bogotá Dc, , Colombia
Cali Valle Del Cauca, , Colombia
Envigado, , Colombia
Manizales, , Colombia
Medellín, , Colombia
Santander, , Colombia
Rijeka, , Croatia
Slavonski Brod, , Croatia
Suska 6, , Croatia
Benešov nad Černou, , Czechia
Brno, , Czechia
České Budějovice, , Czechia
Český Krumlov, , Czechia
Hradec Králové, , Czechia
Kolín, , Czechia
Kroměříž, , Czechia
Litomyšl, , Czechia
Náchod, , Czechia
Pardubice, , Czechia
Plzeò 1, , Czechia
Poruba, , Czechia
Prague, , Czechia
Praha 10 N/A, , Czechia
Slaný, , Czechia
Teplice, , Czechia
Ústí nad Labem, , Czechia
Znojmo, , Czechia
Aalborg, , Denmark
Copenhagen, , Denmark
Esbjerg, , Denmark
Holbæk, , Denmark
Horsens, , Denmark
Kolding, , Denmark
Odense, , Denmark
Alexandria, , Egypt
Cairo, , Egypt
Ismailia, , Egypt
Menofeya, , Egypt
Besançon, , France
Cannes, , France
Chambray-lès-Tours, , France
Chartres, , France
Créteil, , France
Dijon, , France
Haguenau, , France
Lagny, , France
Marseille, , France
Montfermeil, , France
Paris, , France
Poitiers, , France
Bad Friedrichshall, , Germany
Berlin, , Germany
Bonn, , Germany
Dresden, , Germany
Essen, , Germany
Esslingen am Neckar, , Germany
Frankfurt am Main, , Germany
Freiburg im Breisgau, , Germany
Göttingen, , Germany
Greifswald, , Germany
Halle, , Germany
Hamburg, , Germany
Hanover, , Germany
Heidelberg, , Germany
Kiel, , Germany
Leipzig, , Germany
Limburg, , Germany
Lübeck, , Germany
Magdeburg, , Germany
Mannheim, , Germany
Weiden, , Germany
Wermsdorf, , Germany
Witten, , Germany
Athens, , Greece
Larissa, , Greece
Rhodes, , Greece
Thessalonikis, , Greece
Budapest, , Hungary
Debrecen, , Hungary
Győr, , Hungary
Kecskemét, , Hungary
Komárom, , Hungary
Miskolc, , Hungary
Szolnok, , Hungary
Szombathely, , Hungary
Zalaegerszeg, , Hungary
Ahmedabad, , India
Allahābād, , India
Bangalore, , India
Chandigarh, , India
Chennai, , India
Coimbatore, , India
Ernākulam, , India
Gandhinagar Guiarat, , India
Gurgaon, , India
Hyderabad, , India
Jaipur, , India
Karamsad, , India
Kochi, , India
Kolkata, , India
Lucknow Gpo, , India
Ludhiana, , India
Madurai, , India
Mangalore, , India
Mumbai, , India
Mysore, , India
Nagpur, , India
Nashik, , India
New Delhi, , India
Pune, , India
Surat, , India
Trissur, , India
Trivandrum, , India
Vadodara, , India
Vijayawada, , India
Afula, , Israel
Hadera, , Israel
Haifa, , Israel
Jerusalem, , Israel
Nahariya, , Israel
Petah Tikva, , Israel
Rehovot, , Israel
Safed, , Israel
Tel Aviv, , Israel
Tiberias, , Israel
Anan, , Japan
Fukui, , Japan
Fukuoka, , Japan
Fukuyama, , Japan
Gifu, , Japan
Higashiosaka, , Japan
Kagoshima, , Japan
Kanazawa, , Japan
Kasuga, , Japan
Kawachi-Nagano, , Japan
Kawasaki, , Japan
Kisarazu, , Japan
Kobe, , Japan
Kumamoto, , Japan
Kuwana, , Japan
Maebashi-City Gunma, , Japan
Matsudo, , Japan
Matsumoto, , Japan
Matsuyama-City Ehime, , Japan
Miyazaki-Gun, , Japan
Nagano, , Japan
Nagasaki, , Japan
Nagoya, , Japan
Namegata, , Japan
Nankoku, , Japan
Nishinomiya, , Japan
Okayama, , Japan
Osaka, , Japan
Sakaidechō, , Japan
Sakura-Shi, , Japan
Suwa, , Japan
Tokushima, , Japan
Tokyo, , Japan
Toyama, , Japan
Urasoe, , Japan
Yamaguchi, , Japan
Yokohama, , Japan
Yonago-Shi, , Japan
Daugavpils, , Latvia
Liepāja, , Latvia
Riga, , Latvia
Kaunas, , Lithuania
Klaipėda, , Lithuania
Šiauliai, , Lithuania
Vilnius, , Lithuania
Vilnius Lt, , Lithuania
Johor Bahru, , Malaysia
Kelantan, , Malaysia
Kota Samarahan, , Malaysia
Kuala Lumpur, , Malaysia
Selayang Baru Utara, , Malaysia
Aguascalientes, , Mexico
Cd. Juarez, , Mexico
Culiacán, , Mexico
Guadalajara, , Mexico
León, , Mexico
Mexico City, , Mexico
México, , Mexico
Monterrey, , Mexico
Querétaro, , Mexico
San Luis Potosí City, , Mexico
Sinaloa, , Mexico
Veracruz, , Mexico
Zapopan, , Mexico
Marrakesh, , Morocco
Meknes, , Morocco
Rabat, , Morocco
Amsterdam, , Netherlands
Arnhem, , Netherlands
Delft, , Netherlands
Eindhoven, , Netherlands
Gorinchem, , Netherlands
Gouda, , Netherlands
Haarlem, , Netherlands
Harderwijk, , Netherlands
Hengelo Ov, , Netherlands
Nieuwegein, , Netherlands
Nijmegen, , Netherlands
Sittard, , Netherlands
The Hague, , Netherlands
Vlaardingen, , Netherlands
Auckland, , New Zealand
Dunedin, , New Zealand
Hamilton, , New Zealand
Lower Hutt, , New Zealand
Nelson, , New Zealand
New Plymouth, , New Zealand
Iloilo City, , Philippines
Marikina City, , Philippines
Quezon City, , Philippines
Będzin, , Poland
Bialystok, , Poland
Bielsko-Biala, , Poland
Bydgoszcz, , Poland
Bytom, , Poland
Dąbrowa Górnicza, , Poland
Gdynia, , Poland
Gorlice, , Poland
Katowice, , Poland
Katowice-Ochojec, , Poland
Koszalin, , Poland
Krakow, , Poland
Kutno, , Poland
Lodz, , Poland
Nowy Targ, , Poland
Opole, , Poland
Poznan, , Poland
Płock, , Poland
Ruda Śląska, , Poland
Starogard Gdanski Nap, , Poland
Szczecin, , Poland
Torun, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Włocławek, , Poland
Zamość, , Poland
Aveiro, , Portugal
Braga, , Portugal
Coimbra, , Portugal
Faro, , Portugal
Leiria, , Portugal
Lisbon, , Portugal
Penafiel, , Portugal
Porto, , Portugal
Vila Nova de Gaia, , Portugal
Bucharest, , Romania
Craiova, , Romania
Focşani, , Romania
Oradea, , Romania
Piteşti, , Romania
Tg Mures, , Romania
Timișoara, , Romania
Arkhangelsk, , Russia
Barnaul, , Russia
Chelyabinsk, , Russia
Ivanovo, , Russia
Kaliningrad, , Russia
Kemerovo, , Russia
Kirov, , Russia
Krasnodar, , Russia
Krasnoyarsk, , Russia
Kursk, , Russia
Lyubertsy, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Novosibirsk, , Russia
Omsk, , Russia
Orenburg, , Russia
Penza, , Russia
Perm, , Russia
Pskov, , Russia
Pushkin, Saint-Petersburg, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Saint-Petersbrug, , Russia
Sestroretsk, Saint-Petersburg, , Russia
Syktyvkar, , Russia
Tomsk, , Russia
Tula, , Russia
Tumen Region, , Russia
Vladimir, , Russia
Voronezh, , Russia
Yaroslavl Nap, , Russia
Yekaterinburg, , Russia
Belgrade, , Serbia
Kragujevac, , Serbia
Niš, , Serbia
Niška Banja, , Serbia
Bratislava, , Slovakia
Nové Zámky, , Slovakia
Žilina, , Slovakia
Daejeon, , South Korea
Gwangju, , South Korea
Seognam-Si, Kyungki-Do, , South Korea
Seoul, , South Korea
Suwon, , South Korea
Alicante, , Spain
Aviles Asturias, , Spain
Barcelona, , Spain
Burgos, , Spain
Elche, , Spain
Figueres, , Spain
Guadalajara, , Spain
Huelva, , Spain
Madrid, , Spain
Málaga, , Spain
Salamanca, , Spain
Santander, , Spain
Seville, , Spain
Tarragona, , Spain
Valencia, , Spain
Vigo, , Spain
Danderyd, , Sweden
Gothenburg, , Sweden
Jönköping, , Sweden
Linköping, , Sweden
Lund, , Sweden
Malmo, , Sweden
Örebro, , Sweden
Östersund, , Sweden
Umeå, , Sweden
Bangkok, , Thailand
Chiang Mai, , Thailand
Pathum Thani, , Thailand
Phathumwan, , Thailand
Sfax, , Tunisia
Sousse, , Tunisia
Tunis, , Tunisia
Ankara, , Turkey (Türkiye)
Aydin, , Turkey (Türkiye)
Bursa, , Turkey (Türkiye)
Erzurum, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Kayseri, , Turkey (Türkiye)
Samsun, , Turkey (Türkiye)
Sivas, , Turkey (Türkiye)
Cherkassy, , Ukraine
Dnipro, , Ukraine
Donetsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Kharkiv, , Ukraine
Khemelnitskiy, , Ukraine
Kiev, , Ukraine
Luhansk, , Ukraine
Lutsk, , Ukraine
Lviv, , Ukraine
Mykolayiv, , Ukraine
Poltava, , Ukraine
Sumy, , Ukraine
Ternopil, , Ukraine
Uzhhorod, , Ukraine
Vinnitsa, , Ukraine
Zaporizhzhya, , Ukraine
Zhytomyr, , Ukraine
Birmingham, , United Kingdom
Blackpool, , United Kingdom
Bristol, , United Kingdom
Chertsey, , United Kingdom
Chesterfield, , United Kingdom
East Sussex, , United Kingdom
Exeter, , United Kingdom
Hampshire, , United Kingdom
Harrow, , United Kingdom
Hull, , United Kingdom
Leicester, , United Kingdom
Lincoln, , United Kingdom
Manchester, , United Kingdom
Middlesbrough, , United Kingdom
Portadown, , United Kingdom
Stockport, , United Kingdom
Warwick, , United Kingdom
Worcester, , United Kingdom
Countries
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References
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Chi G, AlKhalfan F, Lee JJ, Montazerin SM, Fitzgerald C, Korjian S, Omar W, Barnathan E, Plotnikov A, Gibson CM. Factors associated with early, late, and very late stent thrombosis among patients with acute coronary syndrome undergoing coronary stent placement: analysis from the ATLAS ACS 2-TIMI 51 trial. Front Cardiovasc Med. 2024 Jan 8;10:1269011. doi: 10.3389/fcvm.2023.1269011. eCollection 2023.
Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8.
Gibson CM, Levitan B, Gibson WJ, Yee MK, Murphy SA, Yuan Z, Chakrabarti AK, Lee M, Braunwald E. Fatal or Irreversible Bleeding and Ischemic Events With Rivaroxaban in Acute Coronary Syndrome. J Am Coll Cardiol. 2018 Jul 10;72(2):129-136. doi: 10.1016/j.jacc.2018.04.055.
Cavender MA, Gibson CM, Braunwald E, Wiviott SD, Murphy SA, Toda Kato E, Plotnikov AN, Amuchastegui M, Oude Ophuis T, van Hessen M, Mega JL. The effect of rivaroxaban on myocardial infarction in the ATLAS ACS 2 - TIMI 51 trial. Eur Heart J Acute Cardiovasc Care. 2015 Oct;4(5):468-74. doi: 10.1177/2048872614554109. Epub 2014 Oct 15.
Gibson CM, Chakrabarti AK, Mega J, Bode C, Bassand JP, Verheugt FW, Bhatt DL, Goto S, Cohen M, Mohanavelu S, Burton P, Stone G, Braunwald E; ATLAS-ACS 2 TIMI 51 Investigators. Reduction of stent thrombosis in patients with acute coronary syndromes treated with rivaroxaban in ATLAS-ACS 2 TIMI 51. J Am Coll Cardiol. 2013 Jul 23;62(4):286-90. doi: 10.1016/j.jacc.2013.03.041. Epub 2013 Apr 16.
Mega JL, Braunwald E, Murphy SA, Plotnikov AN, Burton P, Kiss RG, Parkhomenko A, Tendera M, Widimsky P, Gibson CM. Rivaroxaban in patients stabilized after a ST-segment elevation myocardial infarction: results from the ATLAS ACS-2-TIMI-51 trial (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome-Thrombolysis In Myocardial Infarction-51). J Am Coll Cardiol. 2013 May 7;61(18):1853-9. doi: 10.1016/j.jacc.2013.01.066. Epub 2013 Mar 7.
Mega JL, Braunwald E, Wiviott SD, Bassand JP, Bhatt DL, Bode C, Burton P, Cohen M, Cook-Bruns N, Fox KA, Goto S, Murphy SA, Plotnikov AN, Schneider D, Sun X, Verheugt FW, Gibson CM; ATLAS ACS 2-TIMI 51 Investigators. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med. 2012 Jan 5;366(1):9-19. doi: 10.1056/NEJMoa1112277. Epub 2011 Nov 13.
Gibson CM, Mega JL, Burton P, Goto S, Verheugt F, Bode C, Plotnikov A, Sun X, Cook-Bruns N, Braunwald E. Rationale and design of the Anti-Xa therapy to lower cardiovascular events in addition to standard therapy in subjects with acute coronary syndrome-thrombolysis in myocardial infarction 51 (ATLAS-ACS 2 TIMI 51) trial: a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rivaroxaban in subjects with acute coronary syndrome. Am Heart J. 2011 May;161(5):815-821.e6. doi: 10.1016/j.ahj.2011.01.026.
Other Identifiers
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RIVAROXACS3001
Identifier Type: OTHER
Identifier Source: secondary_id
CR014710
Identifier Type: -
Identifier Source: org_study_id
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