Actively Recruiting
Avoiding Anticoagulation After IntraCerebral Haemorrhage
Led by University Hospital, Lille · Updated on 2026-04-07
300
Participants Needed
3
Research Sites
567 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
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.
CONDITIONS
Official Title
Avoiding Anticoagulation After IntraCerebral Haemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult (older than 18 years old, no upper age limit)
- History of paroxysmal, persistent, or long-standing non-valvular atrial fibrillation documented by electrocardiogram
- CHA2DS2VASc score of 2 or more indicating need for long-term anticoagulation
- History of spontaneous intracerebral hemorrhage documented by brain CT or MRI
- Intracerebral hemorrhage occurred more than 14 days before randomization
- Clinical equipoise exists regarding the best preventive strategy for future vascular events
You will not qualify if you...
- Pre-randomization modified Rankin score of 4 or 5
- Conditions other than atrial fibrillation requiring long-term anticoagulation (e.g., mechanical heart valve)
- Serious bleeding events within 6 months before randomization (except intracerebral hemorrhage)
- Life expectancy less than 1 year
- Pregnancy or breastfeeding
- For LAAC only: contraindications due to local anatomical reasons (e.g., thrombus in left atrial appendage, infection risk), age over 85 years, CHA2DS2VASc score of 2 or 3, patient or physician unwilling to undergo LAAC
- For Direct OAC only: chronic renal insufficiency with creatinine clearance <30 ml/min, body weight under 50 kg, allergy to apixaban, conditions increasing head trauma risk (e.g., gait disturbances, uncontrolled seizures), patient or physician unwilling to use Direct OAC
AI-Screening
AI-Powered Screening
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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
Research Team
C
Charlotte Cordonnier, MD, PhD
CONTACT
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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