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 July 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: July 21, 2014
Last verified: July 2014

March 19, 2013
July 21, 2014
May 2013
March 2016   (final data collection date for primary outcome measure)
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.
Number of participants with clinically significant bleeding [ Time Frame: At 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.
Complete list of historical versions of study NCT01830543 on ClinicalTrials.gov Archive Site
  • 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 ]
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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2169
March 2016
March 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
Both
18 Years and older
No
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
United States,   Argentina,   Australia,   Belgium,   Bulgaria,   Canada,   Chile,   Czech Republic,   Denmark,   France,   Germany,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Poland,   Russian Federation,   South Africa,   Sweden,   Taiwan,   Turkey,   Ukraine,   United Kingdom
 
NCT01830543
CR100758, RIVAROXAFL3003, 2012-001491-11
Yes
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
July 2014

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