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)

August 21, 2017 updated by: Janssen Scientific Affairs, LLC

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2124

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Bahia Blanca, Argentina
      • Buenos Aires, Argentina
      • C.a.b.a., Argentina
      • Cordoba, Argentina
      • Corrientes, Argentina
      • La Plata, Argentina
      • Resistencia, Argentina
      • Rosario, Argentina
      • Santa Fe, Argentina
      • Vicente Lopez, Argentina
  • Australia
      • Chermside N/A, Australia
      • Epping, Australia
      • Hobart, Australia
      • Kogarah, Australia
      • Liverpool, Australia
      • New Lambton, Australia
      • Wollongong, Australia
  • Belgium
      • Aalst, Belgium
      • Bonheiden, Belgium
      • Brasschaat, Belgium
      • Brugge, Belgium
      • Bruxelles, Belgium
      • Genk, Belgium
      • Gent, Belgium
      • Liège, Belgium
      • Mechelen, Belgium
      • Mol, Belgium
      • Roeselare, Belgium
      • Turnhout, Belgium
  • Brazil
      • Belo Horizonte, Brazil
      • Blumenau, Brazil
      • Brasilia, Brazil
      • Campina Grande Do Sul, Brazil
      • Campinas, Brazil
      • Curitiba, Brazil
      • Marilia, Brazil
      • Passo Fundo, Brazil
      • Porto Alegre, Brazil
      • Recife, Brazil
      • Sao Paulo, Brazil
      • São José Do Rio Preto, Brazil
      • São Paulo, Brazil
      • Uberlandia, Brazil
      • Votuporanga, Brazil
  • Bulgaria
      • Blagoevgrad, Bulgaria
      • Burgas, Bulgaria
      • Pazardjik, Bulgaria
      • Pleven, Bulgaria
      • Plovdiv, Bulgaria
      • Sofia, Bulgaria
      • Varna, Bulgaria
      • Veliko Tarnovo, Bulgaria
  • Canada
      • Chicoutimi, Canada
      • Quebec, Canada
      • Saint John, Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Maple Ridge, British Columbia, Canada
      • New Westminster, British Columbia, Canada
      • Vancouver, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • Newfoundland and Labrador
      • St. John'S, Newfoundland and Labrador, Canada
    • Ontario
      • London, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Sudbury, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
      • Sherbrooke, Quebec, Canada
  • Chile
      • Alto, Chile
      • Concepcion, Chile
      • Punta Arenas, Chile
      • Santiago, Chile
      • Temuco, Chile
  • Czechia
      • Brno, Czechia
      • Brno 2, Czechia
      • Hradec Kralove, Czechia
      • Jablonec Na Nisou, Czechia
      • Karlovy Vary, Czechia
      • Kladno, Czechia
      • Litomysl, Czechia
      • Olomouc, Czechia
      • Plzen, Czechia
      • Praha, Czechia
      • Praha 10 N/A, Czechia
      • Praha 2, Czechia
      • Slany, Czechia
      • Uherske Hradiste, Czechia
  • Denmark
      • Aalborg, Denmark
      • Copenhagen, Denmark
      • Esbjerg, Denmark
      • Herlev, Denmark
      • Herning, Denmark
      • Hvidovre, Denmark
      • Koege, Denmark
      • Naestved, Denmark
      • Odense, Denmark
      • Roskilde, Denmark
      • Svendborg N/A, Denmark
      • Vejle, Denmark
  • France
      • Besancon Cedex Franche-Comté, France
      • Caen Cedex 9, France
      • Centres, France
      • Chartres, France
      • Lille, France
      • Limoges Cedex, France
      • Marseille Cedex 05, France
      • Montfermeil, France
      • Nantes Cedex 1, France
      • Nimes, France
      • Paris, France
      • Paris 75, France
      • Pau, France
      • Pessac, France
      • Poitiers, France
      • Toulouse, France
  • Germany
      • Bad Friedrichshall, Germany
      • Bad Nauheim, Germany
      • Berlin, Germany
      • Dresden, Germany
      • Esslingen, Germany
      • Frankfurt Am Main, Germany
      • Freiburg, Germany
      • Greifswald, Germany
      • Göttingen, Germany
      • Hamburg, Germany
      • Heidelberg, Germany
      • Köln, Germany
      • Limburg, Germany
      • Mannheim, Germany
      • Ulm, Germany
      • Witten, Germany
  • Korea, Republic of
      • Busan, Korea, Republic of
      • Daejeon, Korea, Republic of
      • Gyeonggi-Do, Korea, Republic of
      • Incheon, Korea, Republic of
      • Seongnam, Korea, Republic of
      • Seoul, Korea, Republic of
      • Suwon, Korea, Republic of
      • Uijeongbu, Korea, Republic of
      • Wonju, Korea, Republic of
  • Malaysia
      • Georgetown, Malaysia
      • Johor Bahru, Malaysia
      • Kajang, Malaysia
      • Kuala Lumpur, Malaysia
  • Mexico
      • Aguascalientes, Mexico
      • Guadalajara, Mexico
      • Leon, Mexico
      • Mexico, Mexico
      • Pachuca, Mexico
      • Puebla, Mexico
      • Queretaro, Mexico
      • Villahermosa, Mexico
      • Zapopan, Mexico
  • Netherlands
      • Alkmaar, Netherlands
      • Amsterdam, Netherlands
      • Amsterdam Zuidoost, Netherlands
      • Breda, Netherlands
      • Delft, Netherlands
      • Den Bosch, Netherlands
      • Gorinchem, Netherlands
      • Leiden, Netherlands
      • Maastricht, Netherlands
      • Nieuwegein, Netherlands
      • Sneek, Netherlands
      • Uden, Netherlands
  • Poland
      • Bedzin, Poland
      • Bielsko-Biala, Poland
      • Chrzanow, Poland
      • Gdynia, Poland
      • Grodzisk Mazowiecki, Poland
      • Katowice, Poland
      • Krakow, Poland
      • Lodz, Poland
      • Mielec, Poland
      • Nowy Targ, Poland
      • Ostrowiec Swietokrzyski, Poland
      • Oswiecim, Poland
      • Plock, Poland
      • Rzeszow Poland, Poland
      • Starachowice, Poland
      • Starogard Gdanski, Poland
      • Szczecin, Poland
      • Torun, Poland
      • Tychy, Poland
      • Ustron, Poland
      • Warszawa, Poland
      • Zamosc, Poland
  • Romania
      • Bucharest, Romania
      • Bucuresti, Romania
      • Cluj Napoca, Romania
      • Targu-Mures, Romania
      • Tg Mures, Romania
  • Russian Federation
      • Arkhangelsk, Russian Federation
      • Barnaul, Russian Federation
      • Chita, Russian Federation
      • Ekaterinburg, Russian Federation
      • Kemerovo, Russian Federation
      • Krasnodar, Russian Federation
      • Krasnoyarsk, Russian Federation
      • Moscow, Russian Federation
      • Nizhny Novgorod, Russian Federation
      • Perm, Russian Federation
      • Rostov On Don, Russian Federation
      • Samara, Russian Federation
      • Saratov, Russian Federation
      • St. Petersburg, Russian Federation
      • Syktyvkar, Russian Federation
      • Tumen, Russian Federation
      • Tyumen, Russian Federation
  • South Africa
      • Cape Town, South Africa
      • Centurion, South Africa
      • Linksfield West, Johannesburg, South Africa
      • Somerset West, South Africa
  • Sweden
      • Falun, Sweden
      • Göteborg, Sweden
      • Jönköping, Sweden
      • Lund, Sweden
      • Malmö, Sweden
      • Stockholm, Sweden
      • Stockholm N/A, Sweden
      • Umeå, Sweden
      • Örebro, Sweden
  • Taiwan
      • Kaohsiung, Taiwan
      • Taichung, Taiwan
      • Tainan, Taiwan
      • Taipei, Taiwan
      • Taoyuan, Taiwan
  • Turkey
      • Ankara, Turkey
      • Antalya, Turkey
      • Bursa, Turkey
      • Gaziantep, Turkey
      • Istanbul, Turkey
      • Istanbul Nap, Turkey
      • Izmir, Turkey
      • Kayseri, Turkey
      • Sivas, Turkey
  • Ukraine
      • Cherkassy, Ukraine
      • Dnepropetrovsk, Ukraine
      • Ivano-Frankivsk, Ukraine
      • Kharkiv, Ukraine
      • Kharkov, Ukraine
      • Khemelnitskiy, Ukraine
      • Kyiv, Ukraine
      • Lviv, Ukraine
      • Odessa, Ukraine
      • Rivne, Ukraine
      • Uzhgorod, Ukraine
      • Zaporizhzhya, Ukraine
  • United Kingdom
      • Bath, United Kingdom
      • Birmingham, United Kingdom
      • Blackburn, United Kingdom
      • Bradford, United Kingdom
      • Clydebank, United Kingdom
      • Cottingham, United Kingdom
      • Coventry, United Kingdom
      • Dorchester, United Kingdom
      • Dundee, United Kingdom
      • Edinburgh, United Kingdom
      • Exeter, United Kingdom
      • Hampshire, United Kingdom
      • Harrow, United Kingdom
      • High Wycombe, United Kingdom
      • London, United Kingdom
      • Middlesbrough N/A, United Kingdom
      • Norwich, United Kingdom
      • Nottingham, United Kingdom
      • Plymouth, United Kingdom
      • Portsmouth, United Kingdom
      • Torquay, United Kingdom
      • Truro, United Kingdom
      • Worcester, United Kingdom
  • United States
    • Alabama
      • Huntsville, Alabama, United States
    • California
      • Los Alamitos, California, United States
      • Mission Viejo, California, United States
      • Oceanside, California, United States
      • Riverside, California, United States
      • Sacramento, California, United States
      • San Francisco, California, United States
      • Stockton, California, United States
      • Thousand Oaks, California, United States
      • Torrance, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
      • Lakewood, Colorado, United States
      • Littleton, Colorado, United States
    • Connecticut
      • Danbury, Connecticut, United States
    • District of Columbia
      • Washington, D.C., District of Columbia, United States
    • Florida
      • Atlantis, Florida, United States
      • Clearwater, Florida, United States
      • Daytona Beach, Florida, United States
      • Jacksonville, Florida, United States
      • Port Charlotte, Florida, United States
      • Safety Harbor, Florida, United States
      • Saint Petersburg, Florida, United States
      • Tallahassee, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Columbus, Georgia, United States
      • Macon, Georgia, United States
      • Marietta, Georgia, United States
    • Idaho
      • Boise, Idaho, United States
    • Illinois
      • Hazel Crest, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
      • Munster, Indiana, United States
    • Louisiana
      • Hammond, Louisiana, United States
      • Lake Charles, Louisiana, United States
      • Slidell, Louisiana, United States
    • Maine
      • Auburn, Maine, United States
      • Bangor, Maine, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Michigan
      • Detroit, Michigan, United States
      • Lansing, Michigan, United States
      • Mount Clemens, Michigan, United States
      • Petoskey, Michigan, United States
      • Ypsilanti, Michigan, United States
    • Missouri
      • Kansas City, Missouri, United States
      • Saint Louis, Missouri, United States
    • Montana
      • Kalispell, Montana, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Hackensack, New Jersey, United States
      • Haddon Heights, New Jersey, United States
      • New Brunswick, New Jersey, United States
      • Newark, New Jersey, United States
      • Ridgewood, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • New York, New York, United States
      • Peekskill, New York, United States
    • North Carolina
      • Sanford, North Carolina, United States
    • Oklahoma
      • Bartlesville, Oklahoma, United States
      • Oklahoma City, Oklahoma, United States
      • Tulsa, Oklahoma, United States
    • Oregon
      • Bend, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Abington, Pennsylvania, United States
      • Camp Hill, Pennsylvania, United States
      • Doylestown, Pennsylvania, United States
      • Erie, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Sayre, Pennsylvania, United States
      • York, Pennsylvania, United States
    • South Carolina
      • Greenville, South Carolina, United States
      • Mount Pleasant, South Carolina, United States
    • South Dakota
      • Rapid City, South Dakota, United States
    • Tennessee
      • Jackson, Tennessee, United States
      • Knoxville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Fort Worth, Texas, United States
      • Humble, Texas, United States
      • Odessa, Texas, United States
      • Plano, Texas, United States
    • Utah
      • Layton, Utah, United States
    • Virginia
      • Charlottesville, Virginia, United States
      • Manassas, Virginia, United States
      • Midlothian, Virginia, United States
      • Richmond, Virginia, United States
    • Washington
      • Bellevue, Washington, United States
      • Seattle, Washington, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States
      • Weston, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: 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
Drug: vitamin K antagonist (VKA)
Dose-adjusted VKA tablet (target International Normalized Ratio (INR) 2.0 to 3.0) once daily for 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Clinically Significant Bleeding
Time Frame: Up to Month 12
Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA). TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of greater than or equal to (>=) 5 grams per deciliter (g/dL) (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent (%)). TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to less than (<) 5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent). A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.
Up to Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12
TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, Clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of >= 5 g/dL (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent).
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding
Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12
TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to <5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent).
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)
Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12
A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)
Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12
Percentage of participants who experienced adverse cardiovascular events (cardiovascular death, myocardial Infarction (MI) and stroke) collectively, were assessed.
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Percentage of Participants With Cardiovascular Death
Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12
The percentage of participants with the first occurrence of cardiovascular death were evaluated.
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Percentage of Participants With Myocardial Infarction
Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12
The percentage of participants with the first occurrence of Myocardial Infarction were evaluated.
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Percentage of Participants With Stroke
Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12
The percentage of participants with the first occurrence of Stroke were evaluated.
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Percentage of Participants With Stent Thrombosis
Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12
The percentage of participants with the first occurrence of stent thrombosis were evaluated.
Up to Month 12 and end of DAPT-Month 1, 6 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Scientific Affairs, LLC

Collaborators

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 10, 2013

Primary Completion (ACTUAL)

July 28, 2016

Study Completion (ACTUAL)

July 28, 2016

Study Registration Dates

First Submitted

March 19, 2013

First Submitted That Met QC Criteria

April 11, 2013

First Posted (ESTIMATE)

April 12, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 19, 2017

Last Update Submitted That Met QC Criteria

August 21, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR100758
  • RIVAROXAFL3003 (OTHER: Janssen Scientific Affairs, LLC)
  • 2012-001491-11 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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