Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Rivaroxaban (Xarelto, BAY59-7939); Vitamin K antagonist (VKA)
Intervention description: Rivaroxaban 20 mg orally once daily; subjects with moderate renal impairment (ie, CrCl of 30 to 49 mL/min, inclusive) will receive the adjusted dose of 15 mg orally once daily in the study; VKA orally once daily titrated to a target international normalized ratio (INR) of 2.5 (range 2.0-3.0, inclusive); the VKA type (eg, warfarin, acenocoumarol, phenprocoumon, fluindione, etc) will be assigned by the investigator according to local treatment standards
Intervention MeSH terms: Vitamin K; Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1504.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rivaroxaban; oral anticoagulant; nonvalvular atrial fibrillation; cardioversion; stroke; transient ischemic attack; thromboembolism; cardiovascular event

Summary:

      A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo
      cardioversion (procedure to restore normal heart rhythm). The study will compare patients
      assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist (VKA).
      The study will measure common medical outcomes for this type of patient such as bleeding and
      stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women aged >= 18 years

          -  Hemodynamically stable nonvalvular atrial fibrillation longer than 48 hours or of
             unknown duration

          -  Scheduled for cardioversion (electrical or pharmacological) of nonvalvular atrial
             fibrillation

          -  Women of childbearing potential and men must agree to use adequate contraception when
             sexually active

        Exclusion Criteria:

          -  Severe, disabling stroke (modified Rankin score of 4- 5, inclusive) within 3 months or
             any stroke within 14 days prior to randomization

          -  Transient ischemic attack within 3 days prior to randomization

          -  Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days
             prior to randomization

          -  Acute Myocardial infarction (MI) within the last 14 days prior to randomization

          -  Cardiac-related criteria: known presence of cardiac thombus or myxoma or valvular
             atrial fibrillation

          -  Active bleeding or high risk for bleeding contraindicating anticoagulant therapy

          -  Concomitant medications: indication for anticoagulant therapy other than atrial
             fibrillation, chronic aspirin therapy > 100 mg daily or dual antiplatelet therapy,
             strong inhibitors of both cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp) if used
             systemically

          -  Concomitant conditions: childbearing potential without proper contraceptive measures,
             pregnancy, or breast feeding; hypersensitivity to investigational treatment or
             comparator treatment; calculated creatinine clearance (CrCl) < 30 mL/minute; hepatic
             disease which is associated with coagulopathy leading to a clinically relevant
             bleeding risk; any severe condition that would limit life expectancy to less than 6
             months; planned invasive procedure with potential for uncontrolled bleeding; inability
             to take oral medication; ongoing drug addiction or alcohol abuse

          -  Any other contraindication listed in the local labeling for the comparator treatment
             or experimental treatment

          -  Participation in a study with an investigational drug or medical device within 30 days
             prior to randomization