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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:
ClinicalTrials.gov Identifier:
NCT01830543
First Posted: April 12, 2013
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bayer
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
March 19, 2013
April 12, 2013
June 30, 2017
July 31, 2017
September 19, 2017
May 10, 2013
July 28, 2016   (Final data collection date for primary outcome measure)
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.
Number of participants with clinically significant bleeding [ Time Frame: At Month 12 ]
Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention.
Complete list of historical versions of study NCT01830543 on ClinicalTrials.gov Archive Site
  • 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.
Event rate of the composite of cardiovascular death, Myocardial Infarction (MI) and stroke [ Time Frame: At the end of prespecified duration of Dual Antiplatelet Therapy (DAPT) (Month 1, Month 6 or Month 12) and at Month 12 ]
Not Provided
Not Provided
 
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
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).

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Percutaneous Coronary Intervention
  • 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: 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 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
    Interventions:
    • Drug: rivaroxaban 2.5 mg
    • Drug: rivaroxaban 15 mg
    • Drug: rivaroxaban 10 mg
    • Drug: aspirin (ASA)
    • Drug: clopidogrel
    • Drug: prasugrel
    • Drug: ticagrelor
  • 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
    Interventions:
    • Drug: aspirin (ASA)
    • Drug: vitamin K antagonist (VKA)
    • Drug: clopidogrel
    • Drug: prasugrel
    • Drug: ticagrelor
  • 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
    Interventions:
    • Drug: rivaroxaban 15 mg
    • Drug: rivaroxaban 10 mg
    • Drug: clopidogrel
    • Drug: prasugrel
    • Drug: ticagrelor

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2124
July 28, 2016
July 28, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Czechia,   Denmark,   France,   Germany,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Poland,   Romania,   Russian Federation,   South Africa,   Sweden,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Czech Republic
 
NCT01830543
CR100758
RIVAROXAFL3003 ( Other Identifier: Janssen Scientific Affairs, LLC )
2012-001491-11 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Janssen Scientific Affairs, LLC
Janssen Scientific Affairs, LLC
Bayer
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
Janssen Scientific Affairs, LLC
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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