A Study Exploring Two Strategies of Rivaroxaban (JNJ39039039; BAY-59-7939) and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention
Launched by JANSSEN SCIENTIFIC AFFAIRS, LLC · Apr 11, 2013
Trial Information
Current as of May 02, 2025
Completed
Keywords
ClinConnect Summary
This is an open-label (both physician and participant know the treatment that the participant receives), randomized (study medication is assigned by chance), multicenter clinical study assessing the safety of 2 rivaroxaban treatment strategies and one vitamin K antagonist (VKA) treatment strategy in participants, who have paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and have had a percutaneous coronary intervention (PCI) with stent placement.
A target of 2,100 participants will be randomized into the study, with approximately 700 participants in each treatment...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Have a documented medical history of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF)
- • Have undergone percutaneous coronary intervention (PCI) procedure (with stent placement) for primary atherosclerotic disease
- • Must have an international normalized ratio (INR) of 2.5 or below to be randomized
- • Women must be postmenopausal before entry or practicing a highly effective method of birth control when heterosexually active
- • Be willing and able to adhere to the prohibitions and restrictions specified in the study protocol
- Exclusion Criteria:
- • Have any condition that contraindicates anticoagulant or antiplatelet therapy or would have an unacceptable risk of bleeding, such as, but not limited to: platelet count \<90,000/microliter at screening, history of intracranial hemorrhage, 12 month history of clinically significant gastrointestinal bleeding, non-VKA induced elevated prothrombin time (PT) at screening
- • Have anemia of unknown cause with a hemoglobin level \<10 g/dL (\<6.21 mmol/L)
- • Have a history of stroke or Transient Ischemic Attack (TIA)
- • Have a calculated Creatinine Clearance (CrCl) \<30 mL/min at screening
- • Have known significant liver disease or liver function test (LFT) abnormalities
- • Have any severe condition that would limit life expectancy to less than 12 months
About Janssen Scientific Affairs, Llc
Janssen Scientific Affairs, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing healthcare through innovative research and development. With a focus on delivering transformative therapies across various therapeutic areas, including immunology, oncology, neuroscience, and infectious diseases, Janssen Scientific Affairs plays a pivotal role in bridging the gap between scientific discovery and clinical application. The organization emphasizes collaboration with healthcare professionals, patients, and regulatory agencies to ensure the safety and efficacy of its products, ultimately striving to improve patient outcomes and quality of life. Through rigorous clinical trials and evidence-based approaches, Janssen Scientific Affairs is committed to contributing to the advancement of medical science and addressing unmet medical needs globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Jacksonville, Florida, United States
Indianapolis, Indiana, United States
Kansas City, Missouri, United States
Saint Louis, Missouri, United States
Hackensack, New Jersey, United States
Richmond, Virginia, United States
Quebec, , Canada
San Francisco, California, United States
Tampa, Florida, United States
Albuquerque, New Mexico, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Knoxville, Tennessee, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Lille, , France
Krakow, , Poland
Szczecin, , Poland
Lund, , Sweden
London, , United Kingdom
Baltimore, Maryland, United States
Detroit, Michigan, United States
New York, New York, United States
Brasschaat, , Belgium
Berlin, , Germany
Freiburg, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Ulm, , Germany
Amsterdam, , Netherlands
Den Bosch, , Netherlands
Warszawa, , Poland
Moscow, , Russian Federation
Taipei, , Taiwan
Torrance, California, United States
Clearwater, Florida, United States
Lake Charles, Louisiana, United States
New Brunswick, New Jersey, United States
Bruxelles, , Belgium
Gent, , Belgium
Breda, , Netherlands
Boise, Idaho, United States
Las Vegas, Nevada, United States
Austin, Texas, United States
Oklahoma City, Oklahoma, United States
Huntsville, Alabama, United States
Mannheim, , Germany
Stockholm, , Sweden
Tainan, , Taiwan
Fort Worth, Texas, United States
Sacramento, California, United States
Brugge, , Belgium
Edmonton, Alberta, Canada
Sherbrooke, Quebec, Canada
Buenos Aires, , Argentina
Riverside, California, United States
Auburn, Maine, United States
Tulsa, Oklahoma, United States
Arkhangelsk, , Russian Federation
Krasnodar, , Russian Federation
Samara, , Russian Federation
St. Petersburg, , Russian Federation
Dnepropetrovsk, , Ukraine
Lviv, , Ukraine
Odessa, , Ukraine
Uzhgorod, , Ukraine
Bangor, Maine, United States
Charlottesville, Virginia, United States
Bellevue, Washington, United States
Daytona Beach, Florida, United States
Saint Petersburg, Florida, United States
Tallahassee, Florida, United States
Sayre, Pennsylvania, United States
York, Pennsylvania, United States
Corrientes, , Argentina
Rosario, , Argentina
Bonheiden, , Belgium
Mechelen, , Belgium
Turnhout, , Belgium
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Nimes, , France
Paris, , France
Bad Nauheim, , Germany
Dresden, , Germany
Bedzin, , Poland
Bielsko Biala, , Poland
Katowice, , Poland
Bucuresti, , Romania
Cluj Napoca, , Romania
Göteborg, , Sweden
Middlesbrough N/A, , United Kingdom
Plymouth, , United Kingdom
Roeselare, , Belgium
Olomouc, , Czechia
Praha, , Czechia
Lansing, Michigan, United States
Ottawa, Ontario, Canada
Kaohsiung, , Taiwan
Maastricht, , Netherlands
Colorado Springs, Colorado, United States
Plano, Texas, United States
Marietta, Georgia, United States
Toulouse, , France
Seoul, , Korea, Republic Of
Istanbul, , Turkey
Birmingham, , United Kingdom
Dundee, , United Kingdom
Newark, New Jersey, United States
Roskilde, , Denmark
Macon, Georgia, United States
Greenville, South Carolina, United States
Campinas, , Brazil
Curitiba, , Brazil
Sao Paulo, , Brazil
Edinburgh, , United Kingdom
Santa Fe, , Argentina
St. John's, Newfoundland And Labrador, Canada
Santiago, , Chile
Gyeonggi Do, , Korea, Republic Of
Bucharest, , Romania
Nottingham, , United Kingdom
New Westminster, British Columbia, Canada
Temuco, , Chile
Suwon, , Korea, Republic Of
Johor Bahru, , Malaysia
Centurion, , South Africa
Varna, , Bulgaria
Lodz, , Poland
Barnaul, , Russian Federation
Ekaterinburg, , Russian Federation
Nizhny Novgorod, , Russian Federation
Cape Town, , South Africa
Cherkassy, , Ukraine
Kharkov, , Ukraine
Littleton, Colorado, United States
Bend, Oregon, United States
Aalborg, , Denmark
Bath, , United Kingdom
Bradford, , United Kingdom
Port Charlotte, Florida, United States
Clydebank, , United Kingdom
Brno, , Czechia
Hradec Kralove, , Czechia
Taichung, , Taiwan
Porto Alegre, , Brazil
La Plata, , Argentina
Amsterdam Zuidoost, , Netherlands
Delft, , Netherlands
Nieuwegein, , Netherlands
Köln, , Germany
Safety Harbor, Florida, United States
Cordoba, , Argentina
Kuala Lumpur, , Malaysia
Guadalajara, , Mexico
Tg Mures, , Romania
Taoyuan, , Taiwan
Kharkiv, , Ukraine
Kyiv, , Ukraine
Belo Horizonte, , Brazil
Chartres, , France
Umeå, , Sweden
Bursa, , Turkey
Izmir, , Turkey
Lakewood, Colorado, United States
Recife, , Brazil
Malmö, , Sweden
Atlantis, Florida, United States
Aalst, , Belgium
Genk, , Belgium
Bahia Blanca, , Argentina
Gorinchem, , Netherlands
Leiden, , Netherlands
Danbury, Connecticut, United States
Pleven, , Bulgaria
Plzen, , Czechia
Uherske Hradiste, , Czechia
Ivano Frankivsk, , Ukraine
Torun, , Poland
Dorchester, , United Kingdom
Praha 2, , Czechia
Mexico, , Mexico
Erie, Pennsylvania, United States
Poitiers, , France
Aguascalientes, , Mexico
Zapopan, , Mexico
Copenhagen, , Denmark
Ankara, , Turkey
Truro, , United Kingdom
Liège, , Belgium
Doylestown, Pennsylvania, United States
Mount Pleasant, South Carolina, United States
Busan, , Korea, Republic Of
Daejeon, , Korea, Republic Of
Incheon, , Korea, Republic Of
Coventry, , United Kingdom
Kogarah, , Australia
Harrow, , United Kingdom
Stockton, California, United States
Pessac, , France
Slidell, Louisiana, United States
Stockholm N/A, , Sweden
Esbjerg, , Denmark
Odense, , Denmark
Columbus, Georgia, United States
Petoskey, Michigan, United States
Ypsilanti, Michigan, United States
Abington, Pennsylvania, United States
Pau, , France
Oceanside, California, United States
Wonju, , Korea, Republic Of
Puebla, , Mexico
Alkmaar, , Netherlands
Göttingen, , Germany
Sudbury, Ontario, Canada
Mission Viejo, California, United States
Ostrowiec Swietokrzyski, , Poland
Starachowice, , Poland
Jackson, Tennessee, United States
Odessa, Texas, United States
Saint John, , Canada
Hvidovre, , Denmark
Limoges Cedex, , France
Saratov, , Russian Federation
Tyumen, , Russian Federation
Svendborg N/A, , Denmark
Vejle, , Denmark
Jönköping, , Sweden
Nantes Cedex 1, , France
Norwich, , United Kingdom
Sneek, , Netherlands
Ridgewood, New Jersey, United States
Camp Hill, Pennsylvania, United States
Munster, Indiana, United States
Haddon Heights, New Jersey, United States
Bartlesville, Oklahoma, United States
Humble, Texas, United States
Chermside N/A, , Australia
Frankfurt Am Main, , Germany
Witten, , Germany
Brasilia, , Brazil
Herlev, , Denmark
Targu Mures, , Romania
Washington, D.C., District Of Columbia, United States
Blackburn, , United Kingdom
Burgas, , Bulgaria
São José Do Rio Preto, , Brazil
Georgetown, , Malaysia
Leon, , Mexico
Perm, , Russian Federation
Grodzisk Mazowiecki, , Poland
Plock, , Poland
Weston, Wisconsin, United States
örebro, , Sweden
Somerset West, , South Africa
Layton, Utah, United States
Hobart, , Australia
Liverpool, , Australia
Wollongong, , Australia
Greifswald, , Germany
Exeter, , United Kingdom
Portsmouth, , United Kingdom
Krasnoyarsk, , Russian Federation
Mount Clemens, Michigan, United States
Rapid City, South Dakota, United States
Mol, , Belgium
Blumenau, , Brazil
Campina Grande Do Sul, , Brazil
Marilia, , Brazil
São Paulo, , Brazil
Uberlandia, , Brazil
Koege, , Denmark
Queretaro, , Mexico
Gdynia, , Poland
Kemerovo, , Russian Federation
Antalya, , Turkey
Kayseri, , Turkey
Zaporizhzhya, , Ukraine
Oswiecim, , Poland
Starogard Gdanski, , Poland
Los Alamitos, California, United States
Zamosc, , Poland
Manassas, Virginia, United States
Gaziantep, , Turkey
Maple Ridge, British Columbia, Canada
Tumen, , Russian Federation
Falun, , Sweden
Karlovy Vary, , Czechia
Kladno, , Czechia
Chrzanow, , Poland
Concepcion, , Chile
Kalispell, Montana, United States
Rostov On Don, , Russian Federation
Kajang, , Malaysia
Chita, , Russian Federation
Hammond, Louisiana, United States
Pazardjik, , Bulgaria
Litomysl, , Czechia
Midlothian, Virginia, United States
Blagoevgrad, , Bulgaria
Passo Fundo, , Brazil
Slany, , Czechia
Sivas, , Turkey
Epping, , Australia
Cottingham, , United Kingdom
Resistencia, , Argentina
Veliko Tarnovo, , Bulgaria
Punta Arenas, , Chile
Montfermeil, , France
Bad Friedrichshall, , Germany
Esslingen, , Germany
Limburg, , Germany
Nowy Targ, , Poland
Syktyvkar, , Russian Federation
Khemelnitskiy, , Ukraine
Hampshire, , United Kingdom
Worcester, , United Kingdom
Tychy, , Poland
Naestved, , Denmark
Mielec, , Poland
Vicente Lopez, , Argentina
Votuporanga, , Brazil
Herning, , Denmark
Pachuca, , Mexico
Torquay, , United Kingdom
Marseille Cedex 05, , France
Uijeongbu, , Korea, Republic Of
New Lambton, , Australia
Seongnam, , Korea, Republic Of
Sanford, North Carolina, United States
Caen Cedex 9, , France
Thousand Oaks, California, United States
Ustron, , Poland
Hazel Crest, Illinois, United States
Peekskill, New York, United States
C.A.B.A., , Argentina
Chicoutimi, , Canada
Alto, , Chile
Brno 2, , Czechia
Jablonec Na Nisou, , Czechia
Praha 10 N/A, , Czechia
Besancon Cedex Franche Comté, , France
Centres, , France
Paris 75, , France
Villahermosa, , Mexico
Uden, , Netherlands
Rzeszow Poland, , Poland
Linksfield West, Johannesburg, , South Africa
Istanbul Nap, , Turkey
Rivne, , Ukraine
High Wycombe, , United Kingdom
Patients applied
Trial Officials
Janssen Scientific Affairs, LLC Clinical Trial
Study Director
Janssen Scientific Affairs, LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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