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Search / Trial NCT00809965

An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome

Launched by JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT, L.L.C. · Dec 16, 2008

Trial Information

Current as of May 28, 2025

Completed

Keywords

Rivaroxaban Acute Coronary Syndrome Acs Aspirin Thienopyridine Unstable Angina Myocardial Infarction Anticoagulation Clopidogrel (Plavix)

ClinConnect Summary

Acute coronary syndrome (ACS) is a serious and life threatening condition. Following an acute coronary syndrome event patients are at risk of important additional clinical events such as death, myocardial infarction, and stroke. Six months after patients present with an index event of ST-segment myocardial infarction, approximately 15% will either have died or had another episode of myocardial ischemia, and a similar situation exists for non-ST-segment elevation myocardial infarction/unstable angina patients. This randomized; double-blind; placebo controlled study will evaluate the efficacy...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients must be currently receiving aspirin therapy alone or in combination with a thienopyridine per national or local dosing recommendation
  • 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:
  • Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding
  • Need for continued anticoagulant therapy
  • Significant renal impairment or known significant liver disease

About Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is a leading global biopharmaceutical company dedicated to advancing medical innovation and improving patient outcomes. As a subsidiary of Johnson & Johnson, the organization focuses on the research, development, and commercialization of novel therapeutics across various therapeutic areas, including immunology, oncology, neuroscience, and infectious diseases. With a commitment to scientific excellence and collaboration, the company leverages cutting-edge technologies and a robust pipeline to address unmet medical needs and deliver transformative solutions that enhance the quality of life for patients worldwide.

Locations

Freiburg, , Germany

Greifswald, , Germany

Nagpur, , India

Gdynia, , Poland

Gorlice, , Poland

Kutno, , Poland

Hull, , United Kingdom

Linden, New Jersey, United States

Cortlandt Manor, New York, United States

Osorno X Región, , Chile

Punta Arenas, , Chile

New Delhi, , India

Pune, , India

St Petersburg, , Russian Federation

St. Petersburg, , Russian Federation

Surat, , India

Paris, , France

Esslingen, , Germany

Ernakulam, , India

Beograd, , Serbia

Sousse, , Tunisia

Kagoshima City, , Japan

Frankfurt / Main, , Germany

Gandhinagar Guiarat, , India

Cherkassy, , Ukraine

Varna, , Bulgaria

Medellin, , Colombia

Veliko Tarnovo, , Bulgaria

Huelva N/A, , Spain

Edmonton, Alberta, Canada

Kawachinagano City, , Japan

Kuwana City, , Japan

Kumamoto, , Japan

Litomysl, , Czech Republic

Halle, , Germany

Witten, , Germany

Kelowna, British Columbia, Canada

Horsens N/A, , Denmark

Dnepropetrovsk, , Ukraine

Donetsk, , Ukraine

Tula, , Russian Federation

Athens, , Greece

Zaporozhye, , Ukraine

Ridley Park, Pennsylvania, United States

Mar Del Plata, , Argentina

Rio De Janeiro, , Brazil

Perth, , Australia

Hradec Kralove, , Czech Republic

Guadalajara, , Mexico

Mexico, , Mexico

Pushkin, Saint Petersburg, , Russian Federation

Istanbul, , Turkey

Izmir, , Turkey

Kayseri, , Turkey

Haskovo, , Bulgaria

Overland Park, Kansas, United States

Wichita, Kansas, United States

Veracruz, , Mexico

Zapopan, , Mexico

Voronezh, , Russian Federation

Kursk, , Russian Federation

St Petersburg, Florida, United States

Lacombe, Louisiana, United States

Manchester, , United Kingdom

Sayre, Pennsylvania, United States

Kalispell, Montana, United States

Tokushima, , Japan

Nizhny Novgorod, , Russian Federation

Saint Petersbrug, , Russian Federation

Tomsk, , Russian Federation

Bridgewater, New Jersey, United States

Faro, , Portugal

Krasnodar, , Russian Federation

Buffalo, New York, United States

Magdeburg, , Germany

Lübeck, , Germany

Rhodes, , Greece

Trissur, , India

Kanazawa City, , Japan

Sevlievo, , Bulgaria

Sofia, , Bulgaria

Nanjing, , China

Coimbra, , Portugal

Harbin, , China

Thessalonikis, , Greece

Gurgaon, , India

Vadodara, , India

Nahariya, , Israel

Yokohama Shi, , Japan

Marikina City, , Philippines

Poznan, , Poland

Rehovot, , Israel

Tokyo,, , Japan

Harrow, , United Kingdom

Petah Tikva, , Israel

Middlesbrough, , United Kingdom

Fukuoka Shi,, , Japan

San Luis Potosi, , Mexico

Sinaloa, , Mexico

Sestroretsk, Saint Petersburg, , Russian Federation

St. Petersburg, Florida, United States

Shen Yang, , China

Valparaiso, Indiana, United States

Shenyang, , China

Wausau, Wisconsin, United States

Chartres, , France

Poitiers, , France

Woolloongabba N/A, , Australia

Leon, , Mexico

Kalamazoo, Michigan, United States

Jacksonville, Florida, United States

Kissimmee, Florida, United States

Ormond Beach, Florida, United States

Mount Clemens, Michigan, United States

West Chester, Ohio, United States

Campina Grande Do Sul, , Brazil

Campinas, , Brazil

Curitiba, , Brazil

Oshawa, Ontario, Canada

Chile, , Chile

San Bernardo, , Chile

Hangzhou, , China

San Luis, , Argentina

Gifu City, , Japan

Kawasaki City, , Japan

Kisarazu City, , Japan

Kobe City, , Japan

Seoul, , Korea, Republic Of

Kromeriz, , Czech Republic

Komarom, , Hungary

Miskolc, , Hungary

Chelyabinsk, , Russian Federation

Moscow N/A, , Russian Federation

Moscow, , Russian Federation

Pskov, , Russian Federation

Saint Petersburg, , Russian Federation

Kuala Lumpur, , Malaysia

Selayang N/A, , Malaysia

Aguascalientes, , Mexico

Lviv, , Ukraine

Nikolaev, , Ukraine

Poltava, , Ukraine

Sumy, , Ukraine

Zhytomir, , Ukraine

Warwick, , United Kingdom

Salt Lake City, Utah, United States

Zilina, , Slovakia

Aviles Asturias, , Spain

Figueres, , Spain

Bedford Park, , Australia

Santander, , Spain

Bratislava, , Slovakia

Nové Zámky, , Slovakia

Wroclaw, , Poland

Szolnok, , Hungary

Nagoya, , Japan

Saint Charles Borromee, Quebec, Canada

Tokushima City, , Japan

Los Angeles, California, United States

Saint Georges, Quebec, Canada

Osaka, , Japan

Tokyo, , Japan

Mission Hills, California, United States

Wermsdorf, , Germany

Grand Blanc, Michigan, United States

Hamburg, , Germany

Grand Rapids, Michigan, United States

Trivandrum, , India

Douglas, , Australia

Fukui, , Japan

Cd. Juarez, , Mexico

Queretaro, , Mexico

Iloilo City, , Philippines

Opole, , Poland

St Petersburg N/A, , Russian Federation

Vladimir, , Russian Federation

Sevilla, , Spain

Kobe Shi, , Japan

Stockport, , United Kingdom

Linköping, , Sweden

Samsun, , Turkey

Madurai, , India

Winston Salem, North Carolina, United States

Leuven, , Belgium

Maebashi City Gunma, , Japan

Zamosc, , Poland

Barnaul, , Russian Federation

Hannover, , Germany

Sittard, , Netherlands

Heidelberg, , Germany

New Plymouth, , New Zealand

Tunis, , Tunisia

Ankara, , Turkey

Manizales, , Colombia

Matsudo City, , Japan

Yonago Shi, , Japan

Belo Horizonte, , Brazil

Talcahuano, , Chile

Ahmedabad, , India

Nelson, , New Zealand

Nasik, , India

Portadown, , United Kingdom

Tg Mures, , Romania

Chertsey, , United Kingdom

Delft, , Netherlands

Parkville, , Australia

Syktyvkar, , Russian Federation

Rousse, , Bulgaria

Maple Ridge, British Columbia, Canada

St. John's, Newfoundland And Labrador, Canada

Leipzig, , Germany

Alicante N/A, , Spain

Limburg, , Germany

Worcester, , United Kingdom

Rome, Georgia, United States

Birmingham, Alabama, United States

York, Pennsylvania, United States

Indianapolis, Indiana, United States

Armenia, , Colombia

Southport, , Australia

Cannes, , France

Toyama City, , Japan

Namegata City, , Japan

Daejeon, , Korea, Republic Of

Victoria, British Columbia, Canada

Barranquilla, , Colombia

Bogotá Dc, , Colombia

Leiria, , Portugal

Vina Del Mar, , Chile

Lisboa, , Portugal

Beijing, Beijing, China

Penafiel, , Portugal

Szombathely, , Hungary

Zalaegerszeg, , Hungary

Osaka City, , Japan

Kharkov, , Ukraine

Ivanovo, , Russian Federation

Johnson City, Tennessee, United States

Kaliningrad, , Russian Federation

Ternopol, , Ukraine

Newcastle, , Australia

Porto, , Portugal

Ivano Frankivsk, , Ukraine

Vinnitsa, , Ukraine

Gwangju, , Korea, Republic Of

Kiel, , Germany

Larisa, , Greece

Yokohama N/A, , Japan

København, , Denmark

Focsani, , Romania

Nagoya City, , Japan

Miami, Florida, United States

Santiago Rm, , Chile

Geneva, Alabama, United States

Merrillville, Indiana, United States

Nagasaki, , Japan

Sakura Shi, , Japan

Timisoara, , Romania

Petoskey, Michigan, United States

Oradea, , Romania

Seognam Si, Kyungki Do, , Korea, Republic Of

Uzhgorod, , Ukraine

Ekaterinburg, , Russian Federation

Kemerovo, , Russian Federation

Aydin, , Turkey

Perm, , Russian Federation

Stony Brook, New York, United States

Oklahoma City, Oklahoma, United States

Doylestown, Pennsylvania, United States

Göttingen, , Germany

Penza, , Russian Federation

Kirov, , Russian Federation

Flint, Michigan, United States

Saratoga Springs, New York, United States

Krakow, , Poland

La Plata, , Argentina

Allahabad, , India

Bartlesville, Oklahoma, United States

Vila Nova De Gaia, , Portugal

Birmingham, Alabama, United States

Lincoln, , United Kingdom

Bangalore, , India

Chandigarh, , India

Wloclawek, , Poland

Miami, Florida, United States

Odense, , Denmark

Boston, Massachusetts, United States

Santiago, , Chile

Santa Fe, , Argentina

Syracuse, New York, United States

Higashiosaka City, , Japan

Nankoku City, , Japan

Kasuga, , Japan

Okayama City, , Japan

Ottawa, Ontario, Canada

Cincinnati, Ohio, United States

Sudbury, Ontario, Canada

Granby, Quebec, Canada

Slavonski Brod, , Croatia

Nishinomiya, , Japan

Praha 10 N/A, , Czech Republic

Tianjin, , China

Alexandria, , Egypt

Malaga, , Spain

Burlington, Vermont, United States

Xi'an, , China

Anan, , Japan

Marseille, , France

Weiden, , Germany

Kolding, , Denmark

Bucuresti, , Romania

Szczecin, , Poland

Ryazan, , Russian Federation

Kecskemet, , Hungary

Phathumwan, , Thailand

Shanghai, , China

Fukuyama City,, , Japan

Urasoe City, , Japan

Yamaguchi, , Japan

Vlaardingen, , Netherlands

Ocala, Florida, United States

San Diego, California, United States

Orlando, Florida, United States

Málaga, , Spain

Ruda Slaska, , Poland

Salamanca, , Spain

Warszawa N/A, , Poland

Gorinchem, , Netherlands

Mannheim, , Germany

Budapest N/A, , Hungary

Amarillo, Texas, United States

Columbus, Georgia, United States

Eupen, , Belgium

Burgos, , Spain

Aurora, Colorado, United States

Littleton, Colorado, United States

Tupelo, Mississippi, United States

Langhorne, Pennsylvania, United States

Haguenau, , France

Dijon, , France

Lagny, , France

Győr, , Hungary

Nowy Targ, , Poland

Szczecin N/A, , Poland

Torun, , Poland

Craiova, , Romania

Omsk, , Russian Federation

Orenburg, , Russian Federation

Malmö, , Sweden

Umeå, , Sweden

Miyazaki Gun, , Japan

Vilnius, , Lithuania

Culiacan, , Mexico

Hamilton, , New Zealand

örebro, , Sweden

Saint Louis, Missouri, United States

Chiang Mai, , Thailand

Pathumthani, , Thailand

Sfax, , Tunisia

Porto Alegre, , Brazil

Newmarket, Ontario, Canada

Daqing, , China

Recife, , Brazil

Erzurum, , Turkey

Rijeka, , Croatia

Hampshire, , United Kingdom

Suska 6, , Croatia

Vilnius Lt, , Lithuania

Mobile, Alabama, United States

Temuco, , Chile

Ceske Budejovice, , Czech Republic

Praha 2, , Czech Republic

Ismailia, , Egypt

Menofeya, , Egypt

Koszalin, , Poland

Victoria, , Chile

Pitesti, , Romania

Danderyd, , Sweden

Budapest, , Hungary

Cincinnati, Ohio, United States

Debrecen, , Hungary

Creteil N/A, , France

Jupiter, Florida, United States

Cleveland, Ohio, United States

Bonheiden, , Belgium

Brussels, , Belgium

Genk, , Belgium

Laval, , Canada

Tumen Region, , Russian Federation

Kumamoto City, , Japan

Dayton, Ohio, United States

Novosibirsk, , Russian Federation

Lubbock, Texas, United States

Sherbrooke, Quebec, Canada

Nachod N/A, , Czech Republic

Sao Jose Do Rio Preto, , Brazil

Fairview Park, Ohio, United States

Greenville, South Carolina, United States

Tucuman, , Argentina

Fremantle, , Australia

Heidelberg, , Australia

Herston, , Australia

Blumenau, , Brazil

London, Ontario, Canada

North Battleford, Saskatchewan, Canada

Antofagasta, , Chile

Brno, , Czech Republic

Sao Paulo, , Brazil

Cesky Krumlov N/A, , Czech Republic

Kolin N/A, , Czech Republic

Esbjerg, , Denmark

Holbæk, , Denmark

São Paulo, , Brazil

Bourgas, , Bulgaria

Cairo, , Egypt

Ludhiana, , India

Bad Friedrichshall, , Germany

Berlin, , Germany

Bonn, , Germany

Mangalore, , India

Sakaide City, , Japan

Kota Samarahan, , Malaysia

Suwa City, , Japan

Yokohama City, , Japan

Yokohama, , Japan

Białystok, , Poland

Marrakech, , Morocco

Kragujevac, , Serbia

Bielsko Biala, , Poland

Niska Banja, , Serbia

Nis, , Serbia

Barcelona, , Spain

Elche, , Spain

Katowice, , Poland

Lund, , Sweden

Madrid, , Spain

Munster, Indiana, United States

Dimitrovgrad, , Bulgaria

Usti Nad Labem, , Czech Republic

Khemelnitskiy, , Ukraine

Kiev, , Ukraine

Lugansk, , Ukraine

Lutsk, , Ukraine

Daugavpils, , Latvia

Znojmo N/A, , Czech Republic

Aalborg, , Denmark

Vijayawada, , India

Afula, , Israel

Hadera, , Israel

Haifa, , Israel

Jerusalem, , Israel

Den Haag, , Netherlands

Eindhoven, , Netherlands

Gouda, , Netherlands

Nijmegen, , Netherlands

Auckland, , New Zealand

Katowice Ochojec, , Poland

Tarragona, , Spain

Valencia, , Spain

Vigo, , Spain

Göteborg, , Sweden

Resistencia, , Argentina

Liepaja, , Latvia

Riga, , Latvia

Amsterdam, , Netherlands

Arnhem, , Netherlands

Salta, , Argentina

Pardubice N/A, , Czech Republic

Bethesda, Maryland, United States

Montfermeil, , France

Chennai, , India

Coimbatore, , India

Hyderabad, , India

Kolkata, , India

Kaunas, , Lithuania

Klaipeda, , Lithuania

Siauliai, , Lithuania

Ribeirao Preto, , Brazil

Jinan, , China

Cali Valle Del Cauca, , Colombia

Envigado, , Colombia

Santander, , Colombia

Ciudad De Mexico, , Mexico

Monterrey, , Mexico

Dunedin, , New Zealand

Praha 8, , Czech Republic

Jönköping, , Sweden

Praha, , Czech Republic

Cochin, , India

Valdivia X Región, , Chile

Bydgoszcz, , Poland

Yaroslavl Nap, , Russian Federation

Boston, Massachusetts, United States

Tiberias, , Israel

Plovdiv, , Bulgaria

Corrientes, , Argentina

Plzeò 1, , Czech Republic

Junin, , Argentina

Moron, , Argentina

Morón, , Argentina

Rosario, , Argentina

Epping, , Australia

Launceston, , Australia

Coffs Harbour South, , Australia

Danville, Virginia, United States

Poznan N/A, , Poland

Arkhangelsk, , Russian Federation

Roanoke, Virginia, United States

Buenos Aires, , Argentina

Krasnoyarsk, , Russian Federation

Lyubertsy, , Russian Federation

Chermside N/A, , Australia

Pazardjik, , Bulgaria

Tienen, , Belgium

Pleven, , Bulgaria

Ste Foy, Quebec, Canada

Beijing Prc, , China

Besancon, , France

Changsha, , China

Guangzhou, , China

Dresden, , Germany

Essen, , Germany

Jaipur, , India

Karamsad, , India

Kochi, , India

Lucknow Gpo, , India

Mumbai, , India

Mysore, , India

Starogard Gdanski Nap, , Poland

Milton, , Australia

Bangkok, , Thailand

Safed, , Israel

Tel Aviv, , Israel

Matsumoto, , Japan

Suwon, , Korea, Republic Of

Meknès, , Morocco

Mol, , Belgium

Montreal, Quebec, Canada

Poruba, , Czech Republic

Slany, , Czech Republic

Chambray Les Tours, , France

Rabat, , Morocco

Quezon City, , Philippines

östersund, , Sweden

Bursa, , Turkey

Salvador, , Brazil

Benesov Nad Cernou, , Czech Republic

Matsuyama City Ehime, , Japan

Nagano City, , Japan

Johor Bahru, , Malaysia

Kelantan, , Malaysia

Harderwijk, , Netherlands

Burbank, California, United States

Hengelo Ov, , Netherlands

Nieuwegein, , Netherlands

Belgrade, , Serbia

Warszawa, , Poland

Bedzin, , Poland

Haarlem, , Netherlands

Aveiro, , Portugal

Spokane, Washington, United States

Braga, , Portugal

Birmingham, , United Kingdom

Cordoba, , Argentina

Katowice N/A, , Poland

Plock, , Poland

Lodz, , Poland

Guadalajara, , Spain

Chesterfield, , United Kingdom

East Sussex, , United Kingdom

Blackpool, , United Kingdom

Bristol, , United Kingdom

Anaheim, California, United States

Exeter, , United Kingdom

Dąbrowa Górnicza, , Poland

Sivas, , Turkey

Leicester, , United Kingdom

Memphis, Tennessee, United States

Teplice, , Czech Republic

Odessa, Texas, United States

Tomball, Texas, United States

Huy, , Belgium

Quebec City, Quebec, Canada

Lower Hutt, , New Zealand

Bytom, , Poland

Krakow N/A, , Poland

Patients applied

0 patients applied

Trial Officials

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Study Director

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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