Atrial Fibrillation Clinical Trial
Official title:
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.
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