Antithrombotic treatment after stroke due to intracerebral haemorrhage.
Alexia Cochrane, Chen Chen, Jacqueline Stephen...
https://pubmed.ncbi.nlm.nih.gov/36700520Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID03243175
Avoiding Anticoagulation After Intracerebral Haemorrhage in Atrial Fibrillation Patients Comparing Apixaban, Left Atrial Appendage Closure, and Usual Care
Led by University Hospital, Lille · Updated on 2026-04-07
300
Participants Needed
3
Research Sites
47 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Lille
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to determine the best way to prevent stroke and systemic embolism in adults with non-valvular atrial fibrillation (AF) who have previously experienced an intracerebral haemorrhage (ICH). Oral anticoagulant drugs have shown benefits in preventing stroke in AF patients, but these drugs were not tested in patients with prior ICH. This trial addresses the uncertainty about whether patients with AF and past ICH should use oral anticoagulants, undergo left atrial appendage closure (LAAC), or avoid anticoagulation. Participants are randomly assigned to one of three groups: treatment with the oral anticoagulant Apixaban (5 mg twice daily), treatment with LAAC devices chosen by local teams, or usual care with avoidance of anticoagulation and LAAC, which may include antiplatelet drugs or no antithrombotic treatment. The trial follows patients for 24 months to compare the net clinical benefit, including both major ischaemic and haemorrhagic events. During the study, participants undergo assessments including brain imaging, clinical evaluations using the Modified Rankin Scale and EQ-5D quality of life measures, and monitoring for adverse events. The primary outcome is a composite of major cardiovascular or cerebrovascular ischaemic or haemorrhagic events over 24 months. Secondary outcomes include individual event components, death, and complications related to endovascular treatment. The study is designed to help guide clinical decisions on the safest and most effective stroke prevention strategy for this patient group.
CONDITIONS
Brief Title
Avoiding Anticoagulation After IntraCerebral Haemorrhage
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult aged 18 years or older with no upper age limit
- History of paroxysmal, persistent, or long-standing non-valvular atrial fibrillation confirmed by electrocardiogram
- CHA2DS2VASc score of 2 or more indicating need for long-term anticoagulation
- History of spontaneous intracerebral haemorrhage documented by brain CT or MRI
- Intracerebral haemorrhage occurred more than 14 days before randomization
- Clinical equipoise exists regarding best preventive strategy to avoid future vascular events
You will not qualify if you...
- Modified Rankin score of 4 or 5 before randomization
- Conditions other than atrial fibrillation requiring long-term anticoagulation (e.g., prosthetic mechanical heart valve)
- Serious bleeding events within 6 months before randomization, except intracerebral haemorrhage
- Life expectancy less than 1 year
- Pregnancy or breastfeeding
- For LAAC only: contraindications due to local anatomy, age over 85 years, CHA2DS2VASc score of 2 or 3, or unwillingness to undergo LAAC
- For Direct OAC only: chronic renal insufficiency with creatinine clearance below 30 ml/min, body weight under 50 kg, allergy to apixaban, conditions predisposing to head trauma, or unwillingness to use Direct OAC
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 24 months
Participants receive one of three strategies: anticoagulation with Apixaban taken twice daily; left atrial appendage closure device implantation; or usual care avoiding anticoagulation. This phase lasts for the active intervention period.
Visits scheduled periodically during 24 months to monitor treatment and outcomes
Follow-up
Duration - Up to 24 months after randomization
Participants are monitored for safety and clinical outcomes after treatment, including assessment of complications and functional status.
Visits at 12 and 24 months for outcome assessments
Trial Site Locations
Total: 3 locations
1
Hôpital Roger Salengro, CHU
Lille, France
Actively Recruiting
2
GHICL
Lomme, France
Actively Recruiting
3
CH De Tourcoing
Tourcoing, France
Actively Recruiting
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Research Team
C
Charlotte Cordonnier, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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Published Research Related To This Trial
Risks of recurrent stroke and all serious vascular events after spontaneous intracerebral haemorrhage: pooled analyses of two population-based studies.
Linxin Li, Michael T C Poon, Neshika E Samarasekera...
https://pubmed.ncbi.nlm.nih.gov/34022170