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 (PIONEER AF-PCI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Janssen Scientific Affairs, LLC
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT01830543
First received: March 19, 2013
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various combinations of dual antiplatelet therapy (DAPT) or low-dose aspirin (ASA) or clopidogrel (or prasugrel or ticagrelor).


Condition Intervention Phase
Atrial Fibrillation
Percutaneous Coronary Intervention
Drug: rivaroxaban 2.5 mg
Drug: rivaroxaban 15 mg
Drug: rivaroxaban 10 mg
Drug: aspirin (ASA)
Drug: vitamin K antagonist (VKA)
Drug: clopidogrel
Drug: prasugrel
Drug: ticagrelor
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention

Resource links provided by NLM:


Further study details as provided by Janssen Scientific Affairs, LLC:

Primary Outcome Measures:
  • Number of participants with clinically significant bleeding [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: Yes ]
    Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention.


Secondary Outcome Measures:
  • Number of participants with clinically significant bleeding events [ Time Frame: Day 10, day 30, Month 3, Month 6, Month 9, Month 12 ] [ Designated as safety issue: Yes ]
  • Number of participants with the adverse cardiovascular events (cardiovascular death, Myocardial Infarction, stroke, stent thrombosis) [ Time Frame: Day 10, day 30, Month 3, Month 6, Month 9, Month 12 ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events [ Time Frame: Day 10, day 30, Month 3, Month 6, Month 9, Month 12 ] [ Designated as safety issue: Yes ]
  • Event composite of clinically significant bleeding and adverse cardiovascular events [ Time Frame: At the end of prespecified duration of Dual Antiplatelet Therapy (DAPT) (Month 1, Month 6 or Month 12) and at Month 12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2169
Study Start Date: May 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rivaroxaban 2.5 mg twice daily
rivaroxaban 2.5 mg tablet twice daily plus low-dose aspirin (ASA) 75 to 100 mg once daily and clopidogrel 75 mg tablet once daily (or prasugrel 10 mg tablet once daily or ticagrelor 90 mg tablet twice daily) followed by rivaroxaban 15 mg tablet (or 10 mg for subjects with moderate renal impairment) once daily plus low-dose ASA for 12 months
Drug: rivaroxaban 2.5 mg
One 2.5 mg tablet twice daily for up to twelve months
Drug: rivaroxaban 15 mg
One 15 mg tablet once daily for up to twelve months
Drug: rivaroxaban 10 mg
One 10 mg tablet once daily for up to twelve months
Drug: aspirin (ASA)
Low-dose aspirin tablet once daily for twelve months
Drug: clopidogrel
One 75 mg tablet once daily for up to twelve months
Drug: prasugrel
One 10 mg tablet once daily for up to twelve months
Drug: ticagrelor
One 90 mg tablet twice daily for up to twelve months
Experimental: vitamin K antagonist (VKA)
dose-adjusted vitamin K antagonist (VKA) once daily (target International Normalized Ratio (INR) 2.0 to 3.0) plus low-dose ASA, 75 to 100 mg per day, and clopidogrel 75 mg once daily (or prasugrel 10 mg tablet once daily or ticagrelor 90 mg tablet twice daily) followed by dose-adjusted VKA once daily (target INR 2.0 to 3.0 or 2.0 to 2.5 at the investigator discretion) plus low-dose ASA for 12 months
Drug: aspirin (ASA)
Low-dose aspirin tablet once daily for twelve months
Drug: vitamin K antagonist (VKA)
Dose-adjusted VKA tablet (target International Normalized Ratio (INR) 2.0 to 3.0) once daily for twelve months
Drug: clopidogrel
One 75 mg tablet once daily for up to twelve months
Drug: prasugrel
One 10 mg tablet once daily for up to twelve months
Drug: ticagrelor
One 90 mg tablet twice daily for up to twelve months
Experimental: rivaroxaban 15 mg once daily
rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus clopidogrel 75 mg tablet once daily (or prasugrel 10 mg tablet once daily or ticagrelor 90 mg tablet twice daily) for 12 months
Drug: rivaroxaban 15 mg
One 15 mg tablet once daily for up to twelve months
Drug: rivaroxaban 10 mg
One 10 mg tablet once daily for up to twelve months
Drug: clopidogrel
One 75 mg tablet once daily for up to twelve months
Drug: prasugrel
One 10 mg tablet once daily for up to twelve months
Drug: ticagrelor
One 90 mg tablet twice daily for up to twelve months

Detailed Description:

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 strategy group. The randomization will be stratified by the intended duration of DAPT (1, 6, or 12 months).

The study consists of a screening phase, a 12-month open-label treatment phase, and an end-of-treatment/early withdrawal visit. The total duration of participation in the study for each participant is approximately 12 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01830543

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Huntsville, Alabama, United States
United States, Arizona
Withdrawn
Phoenix, Arizona, United States
United States, Arkansas
Withdrawn
Jonesboro, Arkansas, United States
United States, California
Withdrawn
La Jolla, California, United States
Completed
Los Alamitos, California, United States
Withdrawn
Los Angeles, California, United States
Not yet recruiting
Mission Viejo, California, United States
Withdrawn
Newport Beach, California, United States
Recruiting
Oceanside, California, United States
Recruiting
Riverside, California, United States
Recruiting
Sacramento, California, United States
Not yet recruiting
San Francisco, California, United States
Withdrawn
Santa Ana, California, United States
Withdrawn
Saramento, California, United States
Recruiting
Stockton, California, United States
Recruiting
Thousand Oaks, California, United States
Recruiting
Torrance, California, United States
United States, Colorado
Withdrawn
Colorado Springs, Colorado, United States
Completed
Colorado Springs, Colorado, United States
Withdrawn
Fort Collins, Colorado, United States
Recruiting
Lakewood, Colorado, United States
Completed
Littleton, Colorado, United States
Withdrawn
Wheat Ridge, Colorado, United States
United States, Connecticut
Recruiting
Danbury, Connecticut, United States
Withdrawn
New Haven, Connecticut, United States
Withdrawn
Norwalk, Connecticut, United States
United States, District of Columbia
Recruiting
Washington, District of Columbia, United States
Withdrawn
Washington, District of Columbia, United States
United States, Florida
Recruiting
Atlantis, Florida, United States
Completed
Clearwater, Florida, United States
Recruiting
Daytona Beach, Florida, United States
Withdrawn
Hollywood, Florida, United States
Withdrawn
Jacksonville, Florida, United States
Recruiting
Jacksonville, Florida, United States
Withdrawn
Lake Mary, Florida, United States
Withdrawn
Largo, Florida, United States
Withdrawn
Ocala, Florida, United States
Recruiting
Port Charlotte, Florida, United States
Completed
Safety Harbor, Florida, United States
Completed
St .Petersburg, Florida, United States
Recruiting
Tallahassee, Florida, United States
Recruiting
Tampa, Florida, United States
United States, Georgia
Recruiting
Columbus, Georgia, United States
Withdrawn
Decatur, Georgia, United States
Completed
Macon, Georgia, United States
Recruiting
Marietta, Georgia, United States
United States, Idaho
Recruiting
Boise, Idaho, United States
United States, Illinois
Withdrawn
Harvey, Illinois, United States
Withdrawn
Oaklawn, Illinois, United States
United States, Indiana
Completed
Indianapolis, Indiana, United States
Not yet recruiting
Munster, Indiana, United States
United States, Louisiana
Completed
Hammond, Louisiana, United States
Recruiting
Lake Charles, Louisiana, United States
Completed
Slidell, Louisiana, United States
United States, Maine
Completed
Auburn, Maine, United States
Recruiting
Bangor, Maine, United States
United States, Maryland
Recruiting
Baltimore, Maryland, United States
Withdrawn
Baltimore, Maryland, United States
United States, Michigan
Not yet recruiting
Detroit, Michigan, United States
Recruiting
Lansing, Michigan, United States
Recruiting
Mount Clemens, Michigan, United States
Completed
Petoskey, Michigan, United States
Recruiting
Ypsilanti, Michigan, United States
United States, Minnesota
Withdrawn
Minneapolis, Minnesota, United States
United States, Missouri
Recruiting
Kansas City, Missouri, United States
Recruiting
Saint Louis, Missouri, United States
Recruiting
St. Louis, Missouri, United States
United States, Montana
Recruiting
Kalispell, Montana, United States
United States, Nebraska
Not yet recruiting
Omaha, Nebraska, United States
United States, Nevada
Not yet recruiting
Las Vegas, Nevada, United States
United States, New Jersey
Withdrawn
Bridgewater, New Jersey, United States
Withdrawn
Camden, New Jersey, United States
Recruiting
Hackensack, New Jersey, United States
Recruiting
Haddon Heights, New Jersey, United States
Not yet recruiting
New Brunswick, New Jersey, United States
Recruiting
Newark, New Jersey, United States
Withdrawn
Newark, New Jersey, United States
Recruiting
Ridgewood, New Jersey, United States
United States, New Mexico
Not yet recruiting
Albuquerque, New Mexico, United States
United States, New York
Recruiting
Corlandt Manor, New York, United States
Withdrawn
New York, New York, United States
Recruiting
New York, New York, United States
Completed
Rochester, New York, United States
Withdrawn
Stony Brook, New York, United States
United States, North Carolina
Withdrawn
Charlotte, North Carolina, United States
Withdrawn
Hickory, North Carolina, United States
Withdrawn
Lenior, North Carolina, United States
Recruiting
Sanford, North Carolina, United States
Withdrawn
Winston Salem, North Carolina, United States
United States, Oklahoma
Recruiting
Bartlesville, Oklahoma, United States
Completed
Oklahoma City, Oklahoma, United States
Recruiting
Tulsa, Oklahoma, United States
United States, Oregon
Recruiting
Bend, Oregon, United States
Recruiting
Portland, Oregon, United States
United States, Pennsylvania
Recruiting
Abington, Pennsylvania, United States
Withdrawn
Allentown, Pennsylvania, United States
Withdrawn
Camp Hill, Pennsylvania, United States
Recruiting
Camp Hill, Pennsylvania, United States
Withdrawn
Danville, Pennsylvania, United States
Recruiting
Doylestown, Pennsylvania, United States
Recruiting
Erie, Pennsylvania, United States
Not yet recruiting
Erie, Pennsylvania, United States
Completed
Langhorne, Pennsylvania, United States
Recruiting
Philadelphia, Pennsylvania, United States
Recruiting
Sayre, Pennsylvania, United States
Recruiting
York, Pennsylvania, United States
United States, South Carolina
Withdrawn
Columbia, South Carolina, United States
Recruiting
Greenville, South Carolina, United States
Completed
Mount Pleasant, South Carolina, United States
United States, South Dakota
Recruiting
Rapid City, South Dakota, United States
United States, Tennessee
Withdrawn
Jackson, Tennessee, United States
Recruiting
Jackson, Tennessee, United States
Recruiting
Knoxville, Tennessee, United States
Withdrawn
Nashville, Tennessee, United States
United States, Texas
Completed
Austin, Texas, United States
Withdrawn
Corpus Christi, Texas, United States
Withdrawn
Dallas, Texas, United States
Recruiting
Fort Worth, Texas, United States
Completed
Humble, Texas, United States
Withdrawn
Mission, Texas, United States
Recruiting
Odessa, Texas, United States
Withdrawn
Plano, Texas, United States
Recruiting
Plano, Texas, United States
United States, Utah
Recruiting
Layton, Utah, United States
Withdrawn
Salt Lake City, Utah, United States
United States, Virginia
Recruiting
Charlottesville, Virginia, United States
Recruiting
Manassas, Virginia, United States
Recruiting
Midlothian, Virginia, United States
Withdrawn
Norfolk, Virginia, United States
Recruiting
Richmond, Virginia, United States
United States, Washington
Recruiting
Bellevue, Washington, United States
Recruiting
Seattle, Washington, United States
Withdrawn
Spokane, Washington, United States
Withdrawn
Tacoma, Washington, United States
United States, Wisconsin
Recruiting
Milwaukee, Wisconsin, United States
Recruiting
Weston, Wisconsin, United States
Argentina
Recruiting
Bahia Blanca, Argentina
Recruiting
Buenos Aires, Argentina
Not yet recruiting
Buenos Aires, Argentina
Recruiting
C.a.b.a., Argentina
Withdrawn
Ciudad Autonoma De Buenos Aires, Argentina
Recruiting
Cordoba, Argentina
Recruiting
Corrientes, Argentina
Withdrawn
Esperanza, Argentina
Recruiting
La Plata, Argentina
Recruiting
Resistencia, Argentina
Recruiting
Rosario, Argentina
Recruiting
Santa Fe, Argentina
Withdrawn
Sivas, Argentina
Recruiting
Vicente Lopez, Argentina
Australia
Not yet recruiting
Chermside N/A, Australia
Withdrawn
Concord, Australia
Not yet recruiting
Epping, Australia
Withdrawn
Freemantle, Australia
Not yet recruiting
Hobart, Tasmania, Australia
Not yet recruiting
Kogarah, Australia
Not yet recruiting
New Lambton, Australia
Not yet recruiting
Wollongong, Australia
Belgium
Recruiting
Aalst, Belgium
Withdrawn
Antwerpen, Belgium
Recruiting
Bonheiden, Belgium
Recruiting
Brasschaat, Belgium
Recruiting
Brugge, Belgium
Withdrawn
Brussels, Belgium
Recruiting
Bruxelles, Belgium
Completed
Genk, Belgium
Recruiting
Gent, Belgium
Withdrawn
Hasselt, Belgium
Withdrawn
Leuven, Belgium
Recruiting
Mechelen, Belgium
Recruiting
Mol, Belgium
Recruiting
Roeselare, Belgium
Recruiting
Turnhout, Belgium
Bulgaria
Recruiting
Blagoevgrad, Bulgaria
Not yet recruiting
Burgas, Bulgaria
Recruiting
Pleven, Bulgaria
Recruiting
Plovdiv, Bulgaria
Not yet recruiting
Sofia, Bulgaria
Recruiting
Sofia, Bulgaria
Not yet recruiting
Varna, Bulgaria
Not yet recruiting
Veliko Tarnovo, Bulgaria
Canada, Alberta
Withdrawn
Calgary, Alberta, Canada
Recruiting
Edmonton, Alberta, Canada
Canada, British Columbia
Recruiting
Maple Ridge, British Columbia, Canada
Recruiting
New Westminster, British Columbia, Canada
Recruiting
Vancouver, British Columbia, Canada
Recruiting
Victoria, British Columbia, Canada
Canada, Newfoundland and Labrador
Recruiting
St. John'S, Newfoundland and Labrador, Canada
Canada, Ontario
Withdrawn
Hamilton, Ontario, Canada
Recruiting
London, Ontario, Canada
Withdrawn
Montreal, Ontario, Canada
Withdrawn
Newmarket, Ontario, Canada
Not yet recruiting
Sudbury, Ontario, Canada
Withdrawn
Thunder Bay, Ontario, Canada
Not yet recruiting
Toronto, Ontario, Canada
Canada, Quebec
Not yet recruiting
Montreal, Quebec, Canada
Withdrawn
Montreal, Quebec, Canada
Recruiting
Montreal, Quebec, Canada
Canada, Saskatchewan
Not yet recruiting
Regina, Saskatchewan, Canada
Canada
Not yet recruiting
Chicoutimi, Canada
Not yet recruiting
Quebec, Canada
Recruiting
Saint John, Canada
Withdrawn
Vancouver, Canada
Chile
Recruiting
Alto, Chile
Recruiting
Concepcion, Chile
Withdrawn
La Serena, Chile
Withdrawn
Providencia, Chile
Not yet recruiting
Punta Arenas, Chile
Recruiting
Santiago, Chile
Active, not recruiting
Santiago, Chile
Withdrawn
Talcahuano, Chile
Recruiting
Temuco, Chile
Withdrawn
Valdivia, Chile
Not yet recruiting
Viña Del Mar, Chile
Czech Republic
Not yet recruiting
Brno, Czech Republic
Not yet recruiting
Brno 2, Czech Republic
Withdrawn
Hradec Kralove, Czech Republic
Not yet recruiting
Jablonec Na Nisou, Czech Republic
Not yet recruiting
Karlovy Vary, Czech Republic
Not yet recruiting
Kladno, Czech Republic
Not yet recruiting
Liberec, Czech Republic
Not yet recruiting
Litomysl, Czech Republic
Not yet recruiting
Olomouc, Czech Republic
Not yet recruiting
Plzen, Czech Republic
Not yet recruiting
Praha, Czech Republic
Not yet recruiting
Praha 10 N/A, Czech Republic
Not yet recruiting
Praha 2, Czech Republic
Not yet recruiting
Slany, Czech Republic
Not yet recruiting
Uherske Hradiste, Czech Republic
Denmark
Recruiting
Aalborg, Denmark
Suspended
Copenhagen, Denmark
Recruiting
Esbjerg, Denmark
Suspended
Herlev, Denmark
Not yet recruiting
Herning, Denmark
Suspended
Holbæk, Denmark
Recruiting
Hvidovre, Denmark
Recruiting
Koege, Denmark
Suspended
København, Denmark
Recruiting
Odense, Denmark
Recruiting
Roskilde, Denmark
Withdrawn
Silkeborg N/A, Denmark
Suspended
Svendborg N/A, Denmark
Recruiting
Vejle, Denmark
France
Recruiting
Besancon Cedex Franche-Comté, France
Withdrawn
Boulogne Billancourt, France
Withdrawn
Brest Cedex 2, France
Recruiting
Caen Cedex 9, France
Withdrawn
Cannes, France
Recruiting
Centres, France
Recruiting
Chartres, France
Recruiting
Lille, France
Not yet recruiting
Limoges Cedex 1, France
Recruiting
Marseille Cedex 05, France
Not yet recruiting
Montfermeil, France
Not yet recruiting
Nantes Cedex 1, France
Recruiting
Nimes, France
Withdrawn
Paris, France
Recruiting
Paris, France
Recruiting
Paris 75, France
Withdrawn
Paris Cedex 10, France
Not yet recruiting
Pau, France
Recruiting
Pessac, France
Recruiting
Poitiers, France
Recruiting
Toulouse, France
Germany
Recruiting
Bad Friedrichshall, Germany
Recruiting
Bad Nauheim, Germany
Recruiting
Berlin, Germany
Recruiting
Dresden, Germany
Recruiting
Esslingen, Germany
Recruiting
Frankfurt Am Main, Germany
Recruiting
Freiburg, Germany
Recruiting
Greifswald, Germany
Recruiting
Göttingen, Germany
Recruiting
Hamburg, Germany
Recruiting
Heidelberg, Germany
Withdrawn
Köln, Germany
Recruiting
Limburg, Germany
Recruiting
Mannheim, Germany
Not yet recruiting
Neuwied, Germany
Withdrawn
Saarlouis, Germany
Recruiting
Ulm, Germany
Recruiting
Witten, Germany
Korea, Republic of
Not yet recruiting
Busan, Korea, Republic of
Not yet recruiting
Incheon, Korea, Republic of
Not yet recruiting
Seongnam, Korea, Republic of
Not yet recruiting
Seoul, Korea, Republic of
Mexico
Not yet recruiting
Aguascalientes, Mexico
Not yet recruiting
Ciudad De Mexico, Mexico
Withdrawn
Culiacán, Mexico
Not yet recruiting
Guadalajara, Mexico
Not yet recruiting
Leon, Mexico
Not yet recruiting
Mexico, Mexico
Withdrawn
Mexico City, Mexico
Not yet recruiting
Pachuca, Mexico
Not yet recruiting
Puebla, Mexico
Not yet recruiting
Queretaro, Mexico
Withdrawn
San Luis Potosi, Mexico
Withdrawn
Tlalnepantla De Baz, Mexico
Not yet recruiting
Villahermosa, Mexico
Not yet recruiting
Zapopan, Mexico
Netherlands
Recruiting
Alkmaar, Netherlands
Recruiting
Amsterdam, Netherlands
Recruiting
Amsterdam Zuidoost, Netherlands
Recruiting
Breda, Netherlands
Recruiting
Delft, Netherlands
Recruiting
Den Bosch, Netherlands
Withdrawn
Deventer, Netherlands
Withdrawn
Eindhoven, Netherlands
Completed
Gorinchem, Netherlands
Withdrawn
Heerlen, Netherlands
Withdrawn
Leeuwarden, Netherlands
Recruiting
Leiden, Netherlands
Recruiting
Maastricht, Netherlands
Recruiting
Nieuwegein, Netherlands
Recruiting
Oss, Netherlands
Withdrawn
Schiedam, Netherlands
Recruiting
Sneek, Netherlands
Withdrawn
Zwolle, Netherlands
Poland
Recruiting
Bedzin, Poland
Recruiting
Bielsko-Biala, Poland
Withdrawn
Bydgoszcz, Poland
Withdrawn
Bytom, Poland
Recruiting
Chrzanow, Poland
Withdrawn
Dabrowa Gornicza, Poland
Recruiting
Gdynia, Poland
Withdrawn
Gdynia, Poland
Recruiting
Grodzisk Mazowiecki, Poland
Withdrawn
Kalisz, Poland
Recruiting
Katowice, Poland
Withdrawn
Kedzierzyn Kozle, Poland
Recruiting
Krakow, Poland
Recruiting
Lodz, Poland
Recruiting
Mielec, Poland
Recruiting
Nowy Targ, Poland
Recruiting
Ostrowiec Swietokrzyski, Poland
Recruiting
Oswiecim, Poland
Withdrawn
Plock, Poland
Recruiting
Plock, Poland
Withdrawn
Polanica-Zdroj, Poland
Withdrawn
Poznan, Poland
Withdrawn
Ruda Slaska, Poland
Recruiting
Rzeszow N/A, Poland
Recruiting
Starachowice, Poland
Recruiting
Starogard Gdanski, Poland
Withdrawn
Szczecin, Poland
Recruiting
Szczecin, Poland
Recruiting
Torun, Poland
Recruiting
Tychy, Poland
Recruiting
Ustron, Poland
Withdrawn
Warszawa, Poland
Recruiting
Warszawa, Poland
Withdrawn
Wroclaw, Poland
Recruiting
Zamosc, Poland
Russian Federation
Withdrawn
Arkhangelsk, Russian Federation
Recruiting
Arkhangelsk, Russian Federation
Recruiting
Barnaul, Russian Federation
Withdrawn
Barnaul, Russian Federation
Not yet recruiting
Chita, Russian Federation
Recruiting
Ekaterinburg, Russian Federation
Not yet recruiting
Irkutsk, Russian Federation
Recruiting
Kemerovo, Russian Federation
Recruiting
Krasnodar, Russian Federation
Recruiting
Krasnoyarsk, Russian Federation
Recruiting
Moscow, Russian Federation
Withdrawn
Moscow, Russian Federation
Suspended
Moscow, Russian Federation
Not yet recruiting
Moscow, Russian Federation
Recruiting
Nizhny Novgorod, Russian Federation
Withdrawn
Orenburg, Russian Federation
Recruiting
Perm, Russian Federation
Recruiting
Rostov On Don, Russian Federation
Recruiting
Samara, Russian Federation
Recruiting
Saratov, Russian Federation
Withdrawn
Sestroretsk, Saint-Petersburg, Russian Federation
Recruiting
St. Petersburg, Russian Federation
Recruiting
Syktyvkar, Russian Federation
Recruiting
Tumen, Russian Federation
Recruiting
Tyumen, Russian Federation
Not yet recruiting
Yaroslavl, Russian Federation
South Africa
Withdrawn
Bloemfontein, South Africa
Not yet recruiting
Cape Town, South Africa
Not yet recruiting
Centurion, South Africa
Not yet recruiting
Somerset West, South Africa
Sweden
Recruiting
Falun, Sweden
Recruiting
Göteborg, Sweden
Withdrawn
Göteborg, Sweden
Recruiting
Jönköping, Sweden
Withdrawn
Linköping, Sweden
Recruiting
Lund, Sweden
Recruiting
Malmö, Sweden
Recruiting
Stockholm, Sweden
Recruiting
Stockholm N/A, Sweden
Recruiting
Umeå, Sweden
Withdrawn
Uppsala, Sweden
Recruiting
Örebro, Sweden
Taiwan
Not yet recruiting
Kaohsiung, Taiwan
Not yet recruiting
Taichung, Taiwan
Not yet recruiting
Tainan, Taiwan
Not yet recruiting
Taipei, Taiwan
Not yet recruiting
Taoyuan, Taiwan
Turkey
Recruiting
Ankara, Turkey
Not yet recruiting
Antalya, Turkey
Not yet recruiting
Bursa, Turkey
Withdrawn
Bursa, Turkey
Not yet recruiting
Gaziantep, Turkey
Recruiting
Istanbul, Turkey
Not yet recruiting
Istanbul Nap, Turkey
Not yet recruiting
Izmir, Turkey
Withdrawn
Izmit, Turkey
Not yet recruiting
Kayseri, Turkey
Recruiting
Sivas, Turkey
Ukraine
Recruiting
Cherkassy, Ukraine
Not yet recruiting
Cherkassy, Ukraine
Not yet recruiting
Dnepropetrovsk, Ukraine
Not yet recruiting
Donetsk, Ukraine
Recruiting
Kharkiv, Ukraine
Not yet recruiting
Khemelnitskiy, Ukraine
Withdrawn
Kiev, Ukraine
Not yet recruiting
Kyiv, Ukraine
Recruiting
Lviv, Ukraine
Not yet recruiting
Odessa, Ukraine
Recruiting
Uzhgorod, Ukraine
Not yet recruiting
Vinnytsia, Ukraine
Recruiting
Zaporizhzhya, Ukraine
United Kingdom
Not yet recruiting
Barnet, United Kingdom
Recruiting
Bath, United Kingdom
Withdrawn
Birmingham, United Kingdom
Recruiting
Birmingham, United Kingdom
Recruiting
Blackburn, United Kingdom
Recruiting
Bradford, United Kingdom
Recruiting
Clydebank, United Kingdom
Recruiting
Cottingham, United Kingdom
Recruiting
Dorchester, United Kingdom
Withdrawn
Dudley, United Kingdom
Recruiting
Dundee, United Kingdom
Recruiting
Edinburgh, United Kingdom
Recruiting
Exeter, United Kingdom
Recruiting
Hampshire, United Kingdom
Not yet recruiting
High Wycombe, United Kingdom
Withdrawn
Leicester, United Kingdom
Withdrawn
London, United Kingdom
Recruiting
London, United Kingdom
Not yet recruiting
London, United Kingdom
Recruiting
Middlesbrough N/A, United Kingdom
Recruiting
Norwich, United Kingdom
Recruiting
Nottingham, United Kingdom
Recruiting
Plymouth, United Kingdom
Not yet recruiting
Portsmouth, United Kingdom
Recruiting
Torquay, United Kingdom
Recruiting
Truro, United Kingdom
Recruiting
Worcester, United Kingdom
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Bayer
Investigators
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT01830543     History of Changes
Other Study ID Numbers: CR100758, RIVAROXAFL3003, 2012-001491-11
Study First Received: March 19, 2013
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration
Germany: Ethics Commission
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Bulgaria: Bulgarian Drug Agency
Netherlands: Medicines Evaluation Board (MEB)
Russia: Ministry of Health of the Russian Federation
Romania: National Medicines Agency
Taiwan: Institutional Review Board
Australia: Human Research Ethics Committee
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Janssen Scientific Affairs, LLC:
Atrial Fibrillation
Irregular heart beat
rivaroxaban
aspirin
clopidogrel
prasugrel
ticagrelor
vitamin K antagonist

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Aspirin
Clopidogrel
Vitamin K
Vitamins
Prasugrel
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics

ClinicalTrials.gov processed this record on July 20, 2014