Status:
This study is ongoing, but not recruiting participants. Results should be presented in November 2010.
Purpose:
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.
Interventions:
Rivaroxaban
an oral, once-daily (od), direct Factor Xa
inhibitor in advanced development for the prevention and treatment of thromboembolic disorders.
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Warfarin
Anticoagulant (Vitamin K antagonist)
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Location(s):
United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Columbia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, India, Italy, Korea, Republic of, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Romania, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, &United Kingdom.
Year Started:
2006
Year Presented:
2010
Design:
Interventional, Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study.
Inclusion Criteria
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
Significant mitral stenosis, transient atrial fibrillation caused by a reversible disorder; active internal bleeding,
severe disabling stroke, history of intracranial bleeding,
hemorrhagic disorders.
Patient Involvement:
Patients are randomly assigned to receive rivaroxaban 20 mg od or dose adjusted warfarin (international normalized ratio [INR] 2.0-3.0). Patients and investigators utilize point-of-care INR devices to receive true or sham INR values, depending on the study drug allocation.
Primary Outcome:
Composite of major and non-major clinically relevant bleeding events; any stroke or non-CNS systemic embolism.
Secondary Outcome:
Each category of bleeding events, and adverse events;
composite of stroke, non-CNS systemic embolism, and vascular death.
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Source of Information:
Abstract CT P8 at 2009 International Stroke Conference (February 2009).
ClinicalTrials.gov
Poster Presentation at the 2010 European Stroke Conference [May, 2010]
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Web Links and Publications:
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Trials
Directories