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 "X-VERT"


Phase 3 Results

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