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Anticoagulant
Rivaroxaban for Atrial Fibrillation and Stroke Prevention (BRAIN-AF Trial)
Phase 3
Waitlist Available
Led By Lena Rivard, MD
Research Sponsored by Montreal Heart Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up estimated up to 84 months
Awards & highlights
BRAIN-AF Trial Summary
This trial is testing whether rivaroxaban is better than standard care at reducing stroke, TIA, and neurocognitive decline in people with non-valvular AF and low risk of stroke.
Eligible Conditions
- Atrial Fibrillation
BRAIN-AF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ estimated up to 84 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~estimated up to 84 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite endpoint of stroke, TIA and neurocognitive decline. Neurocognitive decline is defined by a decrease in the MoCA score greater than or equal to 2 at any follow-up visit from baseline.
Secondary outcome measures
Composite including stroke/transient ischemic attack (TIA) and systemic embolic events
Death (total and cardiovascular)
Hospitalization for cardiovascular (myocardial infarction, heart failure, AF, stroke or unstable angina or other cardiovascular events) or bleeding event
+1 moreOther outcome measures
Major clinical bleeding event
BRAIN-AF Trial Design
2Treatment groups
Active Control
Group I: standard of careActive Control1 Intervention
standard of care
Group II: RivaroxabanActive Control1 Intervention
Rivaroxaban 15 mg, orally, once daily, preferably at the same time of the day throughout the study.
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Who is running the clinical trial?
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering PharmaIndustry Sponsor
25 Previous Clinical Trials
120,917 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
4,550 Patients Enrolled for Atrial Fibrillation
Canadian Stroke Prevention Intervention NetworkOTHER
3 Previous Clinical Trials
1,216 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
1,216 Patients Enrolled for Atrial Fibrillation
The Montreal Health Innovations Coordinating Center (MHICC)OTHER
13 Previous Clinical Trials
9,648 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
69 Patients Enrolled for Atrial Fibrillation
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had an allergic reaction to acetylsalicylic acid (aspirin) in the past and you have vascular disease.You have low red blood cell count or low platelet count.You have been diagnosed with dementia.Your memory and thinking test score is less than 25.You have serious kidney problems.You have a certain type of irregular heart rhythm called valvular atrial fibrillation.You are taking other medications that prevent blood clotting.You have had bleeding in your stomach or intestines before.You have a medical condition that makes you more likely to bleed.You have a current, active infection in your heart.You currently have a liver disease that is not under control.You have had an allergic reaction to rivaroxaban in the past.You have had atrial fibrillation in the past 2 years shown on a heart tracing or device.You have a low chance of having a stroke based on certain conditions.
Research Study Groups:
This trial has the following groups:- Group 1: standard of care
- Group 2: Rivaroxaban
Awards:
This trial has 4 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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