RecruitingPhase 3NCT03243175

Avoiding Anticoagulation After IntraCerebral Haemorrhage

Sponsor

University Hospital, Lille

Enrollment

300 participants

Start Date

Jan 17, 2019

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Intracerebral Hemorrhage Microhaemorrhage

Summary

Randomised controlled trials (RCTs) demonstrate a substantial benefit from oral anticoagulant drugs for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation (AF). However, these RCTs excluded patients with prior intracerebral haemorrhage (ICH). Therefore, guidelines are unable to recommend whether oral anticoagulant drugs, in particular non-vitamin K antagonist (called direct OAC) - can be used for patients with AF after an intracerebral haemorrhage. Roughly 30% of adults with ICH have AF but in 2017 it remains unclear whether they should start oral anticoagulant drugs, be treated with left atrial appendage closure (LAAC) or avoid anticoagulation and LAAC.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two strategies to prevent future strokes in people who have had a brain bleed (hemorrhagic stroke) and also have an irregular heartbeat (atrial fibrillation): blood thinners (anticoagulants) versus a small device implanted in the heart to block a pouch where clots form. **You may be eligible if...** - You are over 18 years old - You have a history of atrial fibrillation (an irregular heartbeat) confirmed by an ECG - You have had a spontaneous brain bleed (not from injury) documented by a brain scan - The brain bleed happened more than 14 days ago - Your doctor believes you have a meaningful risk for future stroke or clotting events **You may NOT be eligible if...** - You are severely disabled (unable to care for yourself) from a previous stroke - You need blood thinners for a reason other than atrial fibrillation (like a mechanical heart valve) - You had a major non-brain bleed within the last 6 months - You are pregnant or breastfeeding - Your life expectancy is less than 1 year Talk to your doctor to see if this trial is 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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