A study comparing the efficacy and safety of once-daily oral rivaroxaban with warfarin for the prevention of stroke and embolism in patients with atrial fibrillation.
Phase 3
Completed
- Conditions
- on-central nervous system systemic embolism in subjects with non-valvular atrial fibrillation.StrokeNon-central nervous system systemic embolism in subjects with non-valvular atrial fibrillation.Stroke - Ischaemic
- Registration Number
- ACTRN12607000214437
- Lead Sponsor
- Bayer Australia Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 14269
Inclusion Criteria
Subjects must have documented atrial fibrillation on 2 separate occasions within 6 months before screening.History of 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
Significant mitral stenosis.Transient atrial fibrillation caused by a reversible disorder.Active internal bleeding.Severe disabling stroke.History of intracranial bleeding.Haemorrhagic disorders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary efficacy outcome is the composite of stroke and non-central nervous system systemic embolism.[Measured at the first occurrence from time of randomisation, then every 4 weeks to the end of follow-up period. That is an expected maximum of 32 months, but may extend to 4 years.]
- Secondary Outcome Measures
Name Time Method Individual components of the composite primary outcome; vascular death; myocardial infarctiion; disabling stroke; and all-cause mortality.[Measured at the first occurrence from time of randomisation, then every 4 weeks to the end of follow-up period. That is an expected maximum of 32 months, but may extend to 4 years.]