RecruitingPhase 3ACTRN12609000026224

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


Sponsor

Bristol-Myers Squibb Australia

Enrollment

15,000 participants

Start Date

Apr 1, 2007

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two blood-thinning medicines — apixaban and warfarin — to see which one better prevents strokes and dangerous blood clots in people who have an irregular heart rhythm called atrial fibrillation (AF). AF increases the risk of stroke, and blood thinners help lower that risk. Warfarin is already approved for this purpose. Apixaban is a newer medicine being tested. Participants will be randomly assigned to one of the two treatments and followed over time. You may be eligible if: - You are 18 years or older with atrial fibrillation - You have one or more stroke risk factors, such as: being 75 or older, previous stroke or TIA, heart failure, diabetes, or high blood pressure requiring medication You may NOT be eligible if: - Your AF is caused by a reversible condition (e.g., thyroid disease) - You have significant mitral valve narrowing - You have a high risk of bleeding, including previous bleeding in the brain - You need long-term blood thinners for another reason (e.g., a mechanical heart valve) - Your blood pressure is very high and uncontrolled - You are planning major surgery or an AF ablation procedure - You take high-dose aspirin (more than 165 mg per day) - You had an ischemic stroke in the past 7 days Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 sys

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)

United States of America

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ACTRN12609000026224