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
Condition: Atrial Fibrillation; Percutaneous Coronary Intervention
MeSH terms: Atrial Fibrillation
Intervention: rivaroxaban 2.5 mg; rivaroxaban 15 mg; rivaroxaban 10 mg; aspirin (ASA); vitamin K antagonist (VKA); clopidogrel; prasugrel; ticagrelor
Intervention description: 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
Intervention MeSH terms: Aspirin; Vitamin K; Rivaroxaban; Clopidogrel; Ticagrelor; Prasugrel Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atrial Fibrillation; Irregular heart beat; rivaroxaban; aspirin; clopidogrel; prasugrel; ticagrelor; vitamin K antagonist

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).
    

Eligibility criteria:

        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