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)
Atrial Fibrillation
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring rivaroxaban, oral anticoagulant, nonvalvular atrial fibrillation, cardioversion, stroke, transient ischemic attack, thromboembolism, cardiovascular event
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Rivaroxaban (Xarelto, BAY59-7939)
Vitamin K antagonist (VKA)
A Direct Cardioversion Strategy can be performed only if sufficient anticoagulation is proven during the last 21 days prior to randomization and/or a transesophageal echocardiogram (TEE) is planned before cardioversion. Rivaroxaban will be given for 1-5 days before planned direct cardioversion. The run-in of 1-5 days is needed due to potential pretreatment with VKA. Treatment with rivaroxaban will be continued for 42 days after the cardioversion. A Delayed Cardioversion Strategy will be chosen if sufficient anticoagulation is not proven during the last 21 days prior to randomization and no TEE is planned. Rivaroxaban will be given for at least 21 (+4) days before the planned cardioversion, to a maximum of 56 (+4) days prior to planned cardioversion.
A Direct Cardioversion Strategy can be performed only if sufficient anticoagulation is proven during the last 21 days prior to randomization and/or a transesophageal echocardiogram (TEE) is planned before cardioversion. VKA will be given for 1-5 days before planned direct cardioversion. The run-in of 1-5 days is needed due to potential pretreatment with VKA. Treatment with VKA will be continued for 42 days after the cardioversion. A Delayed Cardioversion Strategy will be chosen if sufficient anticoagulation is not proven during the last 21 days prior to randomization and no TEE is planned. VKA will be given for at least 21 (+4) days before the planned cardioversion, to a maximum of 56 (+4) days prior to planned cardioversion.