Clinical trial NCT01830543
Conditions: Atrial Fibrillation Percutaneous Coronary Intervention
Keywords: Atrial Fibrillation Irregular heart beat rivaroxaban aspirin clopidogrel prasugrel ticagrelor vitamin K antagonist
Sponsor: Janssen Scientific Affairs, LLC
Start date: 2013-05-10; Completion date: 2016-07-28
Enrollment: 2124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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).

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.

Arms: arm 1: 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 arm 2: 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 arm 3: 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: intervention 1: rivaroxaban 2.5 mg intervention 2: rivaroxaban 15 mg intervention 3: rivaroxaban 10 mg intervention 4: aspirin (ASA) intervention 5: vitamin K antagonist (VKA) intervention 6: clopidogrel intervention 7: prasugrel intervention 8: ticagrelor
Intervention descriptions: intervention 1: One 2.5 mg tablet twice daily for up to twelve months intervention 2: One 15 mg tablet once daily for up to twelve months intervention 3: One 10 mg tablet once daily for up to twelve months intervention 4: Low-dose aspirin tablet once daily for twelve months intervention 5: Dose-adjusted VKA tablet (target International Normalized Ratio (INR) 2.0 to 3.0) once daily for twelve months intervention 6: One 75 mg tablet once daily for up to twelve months intervention 7: One 10 mg tablet once daily for up to twelve months intervention 8: One 90 mg tablet twice daily for up to twelve months

Protocol documents: