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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: Janssen Research & Development, LLC
• Treatments: Rivaroxaban; Vitamin K; Vitamins

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