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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 has been completed.
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC Identifier:
First received: March 19, 2013
Last updated: October 13, 2016
Last verified: October 2016
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 ]

Enrollment: 2129
Study Start Date: May 2013
Study Completion Date: July 2016
Primary Completion Date: July 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01830543

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Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Janssen Scientific Affairs, LLC Identifier: NCT01830543     History of Changes
Other Study ID Numbers: CR100758  RIVAROXAFL3003  2012-001491-11 
Study First Received: March 19, 2013
Last Updated: October 13, 2016
Health Authority: Australia: Human Research Ethics Committee
Germany: Ethics Commission
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Taiwan: Institutional Review Board
United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Australia: National Institute for Quality and Organizational Development in Healthcare and Medicines
Netherlands: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Janssen Scientific Affairs, LLC:
Atrial Fibrillation
Irregular heart beat
vitamin K antagonist

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vitamin K
Prasugrel Hydrochloride
Growth Substances
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics processed this record on January 18, 2017