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

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.

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