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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.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT01830543
First received: March 19, 2013
Last updated: August 21, 2017
Last verified: August 2017
  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
Intervention Model: Parallel Assignment
Masking: None (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:
  • 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.


Secondary Outcome Measures:
  • 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).

  • 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).

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 2124
Actual Study Start Date: May 10, 2013
Study Completion Date: July 28, 2016
Primary Completion Date: July 28, 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   (Adult, Senior)
Sexes Eligible for Study:   All
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

  Show 356 Study Locations
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Bayer
Investigators
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT01830543     History of Changes
Other Study ID Numbers: CR100758
RIVAROXAFL3003 ( Other Identifier: Janssen Scientific Affairs, LLC )
2012-001491-11 ( EudraCT Number )
Study First Received: March 19, 2013
Results First Received: June 30, 2017
Last Updated: August 21, 2017

Studies a U.S. FDA-regulated Device Product: No

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
Vitamins
Vitamin K
Aspirin
Ticlopidine
Clopidogrel
Prasugrel Hydrochloride
Rivaroxaban
Ticagrelor
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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

ClinicalTrials.gov processed this record on September 21, 2017