A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-inferiority Study Comparing the Efficacy and Safety of Once Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation (39039039AFL3001)
Phase 3
Completed
- Conditions
- atrial fibrillationthromboembolic complications10007521
- Registration Number
- NL-OMON35625
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
Adult subjects with non valvular atrial fibrillation and prior stroke, TIA or non CNS systemic embolism or who have 2 or more of the following risk factors: age >_75 years, hypertension, heart failure and/or left ventricular ejection fraction <_35% or diabetes mellitus.
Exclusion Criteria
Patients with cardiac-related conditions, hemorrhage risk-related criteria and concomitant conditions and therapies that will have an impact on the wellbeing of the patient when used simultaneously with the studymedication.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy outcome is the composite of stroke and non CNS systemic<br /><br>embolism. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Major secondary efficacy endpoints include the composite of stroke, non CNS<br /><br>systemic embolism, and vascular death; and the composite of stroke, non CNS<br /><br>systemic embolism, myocardial infarction, and vascular death. Other secondary<br /><br>efficacy endpoints include: individual components of the composite primary and<br /><br>major secondary efficacy endpoints; disabling stroke; and all-cause mortality.</p><br>