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.
One 2.5 mg tablet twice daily for up to twelve months
One 15 mg tablet once daily for up to twelve months
One 10 mg tablet once daily for up to twelve months
Low-dose aspirin tablet once daily for twelve months
Dose-adjusted VKA tablet (target International Normalized Ratio (INR) 2.0 to 3.0) once daily for twelve months
One 75 mg tablet once daily for up to twelve months
One 10 mg tablet once daily for up to twelve months
One 90 mg tablet twice daily for up to twelve months
Bahía Blanca, Argentina
Buenos Aires, Argentina
C.a.b.a., Argentina
Corrientes, Argentina
Córdoba, Argentina
La Plata, Argentina
Resistencia, Argentina
Rosario, Argentina
Santa Fe, Argentina
Vicente López, Argentina