An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillatio
Phase 3
Completed
- Registration Number
- CTRI/2009/091/000201
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14266
Inclusion Criteria
Inclusion Criteria:
* Male and female patients 18 years of age or older
* Subjects must have documented atrial fibrillation on 2 separate occasions within 6 months before screening
* History of a prior stroke, transient ischemic attack or non-neurologic systemic embolism believed to be cardiac in origin, OR at least two of the following risk factors:
* Heart failure
* Hypertension
* Age 75 years or greater
* Diabetes mellitus
Exclusion Criteria
Exclusion Criteria:
* Significant mitral stenosis
* Transient atrial fibrillation caused by a reversible disorder
* Active internal bleeding
* Severe disabling stroke
* History of intracranial bleeding
* Hemorrhagic disorders
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method