Evaluate the Safety of Rivaroxaban in adult subjects with irregular heart rhythm beat (called atrial fibrillation) and a stent placed in heart artery.

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 - PIONEER AF-PCI - PIONEER AF-PCI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001491-11-DE

Enrollment

2109

Registered

2013-02-05

Start date

2013-05-03

Completion date

Unknown

Last updated

2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of stroke and non-CNS systemic embolism in patients with nonvalvular atrial fibrillation who undergo percutaneous coronary intervention MedDRA version: 19.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Xarelto Product Name: Rivaroxaban Product Code: BAY 59-7939 (JNJ-39039039) Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RIVAROXABAN CAS Number: 366789-02-8 Current Sponsor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Have a documented medical history of paroxysmal, persistent, or permanent non-valvular AF Have undergone PCI procedure (with stent placement) for primary atherosclerotic disease Be willing and able to adhere to the prohibitions and restrictions specified in this protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1320 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 780

Exclusion criteria

Exclusion criteria: • Has 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/µL at screening; history of intracranial hemorrhage, 12 month history of clinically significant gastrointestinal bleeding, non-VKA induced elevated PT or INR at screening or prerandomization • Has anemia of unknown cause with a hemoglobin level <10 g/dL (<6.21 mmol/L) • Has a history of stroke or TIA • Has calculated CrCl <30 mL/min at screening or prerandomization • Has known significant liver disease or liver function test (LFT) abnormalities • Has any severe condition that would limit life expectancy to less than 12 months

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to assess the safety of 2 rivaroxaban treatment strategies and a dose-adjusted VKA treatment strategy after PCI (with stent placement) in subjects with paroxysmal, persistent, or permanent non-valvular AF, based on the composite of TIMI major bleeding, minor bleeding, and bleeding requiring medical attention events (known collectively as clinically significant bleeding) after 12 months of therapy.;Secondary Objective: The secondary objectives are to explore the differences between the treatment strategy groups in terms of: ? TIMI major bleeding, minor bleeding, and bleeding requiring medical attention events ? the composite and each component of adverse cardiovascular events (cardiovascular death, MI, and stroke) ? stent thrombosis events ? TIMI major bleeding, minor bleeding, and bleeding requiring medical attention events, and the composite and each component of adverse cardiovascular events (cardiovascular death, MI, stroke) at the end of intended DAPT period;Primary end point(s): The primary safety endpoint for this study is the occurrence of the composite of TIMI major bleeding, minor bleeding, and bleeding requiring medical attention events (known collectively as clinically significant bleeding) ;Timepoint(s) of evaluation of this end point: From Percutaneous Coronary Intervention procedure to Month 12.	—

Measure

Time frame

Main Objective: The primary objective of this study is to assess the safety of 2 rivaroxaban treatment strategies and a dose-adjusted VKA treatment strategy after PCI (with stent placement) in subjects with paroxysmal, persistent, or permanent non-valvular AF, based on the composite of TIMI major bleeding, minor bleeding, and bleeding requiring medical attention events (known collectively as clinically significant bleeding) after 12 months of therapy.;Secondary Objective: The secondary objectives are to explore the differences between the treatment strategy groups in terms of: ? TIMI major bleeding, minor bleeding, and bleeding requiring medical attention events ? the composite and each component of adverse cardiovascular events (cardiovascular death, MI, and stroke) ? stent thrombosis events ? TIMI major bleeding, minor bleeding, and bleeding requiring medical attention events, and the composite and each component of adverse cardiovascular events (cardiovascular death, MI, stroke) at the end of intended DAPT period;Primary end point(s): The primary safety endpoint for this study is the occurrence of the composite of TIMI major bleeding, minor bleeding, and bleeding requiring medical attention events (known collectively as clinically significant bleeding) ;Timepoint(s) of evaluation of this end point: From Percutaneous Coronary Intervention procedure to Month 12.

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: From Percutaneous Coronary Intervention procedure to the end of DAPT period (by prespecified duration of 1, 6, or 12 months) and at Month 12.;Secondary end point(s): The secondary endpoints for this study are the proportions of subjects at the end of DAPT and at Month 12 with the following events: · Each component of the TIMI clinically significant bleeding composite (TIMI major bleeding, minor bleeding, and bleeding requiring medical attention) · The composite of adverse cardiovascular events (cardiovascular death, MI, and stroke) · Cardiovascular death · Myocardial infarction · Stroke · Stent thrombosis	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: From Percutaneous Coronary Intervention procedure to the end of DAPT period (by prespecified duration of 1, 6, or 12 months) and at Month 12.;Secondary end point(s): The secondary endpoints for this study are the proportions of subjects at the end of DAPT and at Month 12 with the following events: · Each component of the TIMI clinically significant bleeding composite (TIMI major bleeding, minor bleeding, and bleeding requiring medical attention) · The composite of adverse cardiovascular events (cardiovascular death, MI, and stroke) · Cardiovascular death · Myocardial infarction · Stroke · Stent thrombosis

—

Countries

Argentina, Belgium, Bulgaria, Canada, Chile, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Poland, Russian Federation, Sweden, United Kingdom, United States

Contacts

Public ContactPeter Wildgoose

Janssen Scientific Affairs

pwildgoo@its.jnj.com011908927 6803

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026