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

Completed · Phase 3

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT01674647

Run by

Bayer

People needed

1504

Starts

2012-10-01

Expected to finish

2014-01-01

Last updated by the study team

2015-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — East Palo Alto, California, United States
• Study site — El Cajon, California, United States
• Study site — National City, California, United States
• Study site — Sacramento, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Torrance, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Stamford, Connecticut, United States
• Study site — Wilmington, Delaware, United States
• Study site — Clearwater, Florida, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Deltona, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Lakeland, Florida, United States
• Study site — Melbourne, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Saint Augustine, Florida, United States
• Study site — Tallahassee, Florida, United States
• Study site — Savannah, Georgia, United States
• Study site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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