None listed
Conditions
Brief summary
The purpose of this study is to demonstrate that the efficacy and safety of 20 mg once daily rivaroxaban in preventing thromboembolic events in subjects with atrial fibrillation not related to mitral valve stenosis. Subjects with moderate renal impairment at screening (defined as calculated creatinine clearance between 30 and 49 ml/min inclusive) will receive a dose adaptation to rivaroxaban 15 mg once daily.
Interventions
This study is comparing the efficacy and safety of rivaroxaban with warfarin for the prevention of stroke and non-central nervous system systemic embolism in subjects with non-valvular atrial fibrillation. Those subjects assigned to rivaroxaban will receive rivaroxaban 20 mg orally once daily, plus warfarin placebo titrated to a sham International Normalised Ratio. Subjects with moderate renal impairment at screening (defined as calculated creatinine clearance between 30 and 49 ml/min inclusive)
This study is comparing the efficacy and safety of rivaroxaban with warfarin for the prevention of stroke and non-central nervous system systemic embolism in subjects with non-valvular atrial fibrillation. Those subjects assigned to rivaroxaban will receive rivaroxaban 20 mg orally once daily, plus warfarin placebo titrated to a sham International Normalised Ratio. Subjects with moderate renal impairment at screening (defined as calculated creatinine clearance between 30 and 49 ml/min inclusive) will receive a dose adaptation to rivaroxaban 15 mg once daily. The duration of the treatment period for a given subject will depend on the time required to accrue the required number of adjudicated primary efficacy endpoint events. As a result, the time on study drug will vary from subject to subject, however the expected maximum duration of the study is 32 months, but may extend to 4 years.
Sponsors
Bayer Australia Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed