Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation
A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects with Nonvalvular Atrial Fibrillation
Bristol-Myers Squibb Australia
15,000 participants
Apr 1, 2007
Interventional
Conditions
Summary
The purpose of this study is to compare the safety and effectiveness of apixaban to warfarin in preventing stroke or clots in subjects with atrial fibrillation and risk factors for stroke. Warfarin is a blood thinning medication approved by the Australian TGA for the prevention of stroke in subjects with atrial fibrillation.
Eligibility
Inclusion Criteria5
- Males and females = 18 yrs with Atrial Fibrillation and one or more of the following risk factors for stroke:
- Age = 75, previous stroke
- Transient Ischemic Attack (TIA) or Systemic Embolism
- Symptomatic congestive heart failure or left ventricular dysfunction with Left Ventricular Ejection Fraction (LVEF) = 40%
- Diabetes mellitus or hypertension requiring pharmacological treatment
Exclusion Criteria11
- Atrial fibrillation or flutter due to reversible causes (e.g. thyrotoxicosis, pericarditis)
- Clinically significant (moderate or severe) mitral stenosis
- Increased bleeding risk that is believed to be a contraindication to oral anticoagulation (e.g. previous intracranial hemorrhage)
- Conditions other than atrial fibrillation that require chronic anticoagulation (e.g.
- prosthetic mechanical heart valve)
- Persistent, uncontrolled hypertension (systolic Blood Pressure (BP) > 180 mm Hg, or diastolic BP
- > 100 mm Hg)
- Planned major surgery
- Planned atrial fibrillation or flutter ablation procedure
- Required treatment with aspirin > 165 mg/day
- Recent ischemic stroke (within 7 days)
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Interventions
Apixaban which is Factor Xa inhibitor. From this intervention treatment, we try to determine if apixaban is noninferior to warfarin in the combined endpoint of stroke (ischemic or hemorrhagic) and systemic embolism, in subjects with Atrial FibrillationF and at least one additional risk factor for stroke. The mode of administration of the intervention treatment is orally taken tablets. The dosage amount and dosage frequency is 5 mg given twice a day or matching placebo for the treatment period. Subjects will receive either apixaban and warfarin-placebo or apixaban-placebo and warfarin following randomization. Treatment period: Lasting until the earlier of a subject’s treatment discontinuation or the attainment of 448 primary efficacy events (average of 1.8 yrs of follow-up from randomization). Follow up period: Lasting until the latter of 30 days after treatment discontinuation or the attainment of 448 primary efficacy events
Locations(1)
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ACTRN12609000026224