Blood thinner or heart appendage closure after brain bleeding with atrial fibrillation
Tests apixaban or appendage closure, or neither, in adults with brain bleeding.
Plain-language title generated from the registry record
Registry title: Avoiding Anticoagulation After IntraCerebral Haemorrhage
Key facts
- Where
- Lille, Lomme, and Tourcoing, FranceSee the 3 sites
- Phase
- Phase 3
Where in France
- Hôpital Roger Salengro, CHULille, FranceTaking people
- GHICLLomme, FranceTaking people
- CH De TourcoingTourcoing, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Lille
- Trial code
- NCT03243175
- Record updated
- 7 April 2026
- Original description
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.Read full original descriptionShow less
Avoiding Anticoagulation After IntraCerebral Haemorrhage
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.
Inclusion: Adult (older than 18 years old, no upper age limit); with a history of paroxysmal, persistent or long-standing non-valvular atrial fibrillation (documented on an electrocardiogram); and a CHA2DS2VASc score of 2 or more who have an indication for long-term anticoagulation; who suffered from a spontaneous intracerebral haemorrhage (while being treated with oral anticoagulants or not) documented with brain CT or MRI; more than 14 days before randomization (no upper delay limit); for whom there is a clinical equipoise regarding the choice of the best preventive strategy to avoid future vascular events.
Exclusion: Serious bleeding events within the 6 months before randomisation (except for intracerebral haemorrhage); Conditions other than atrial fibrillation for which the patient requires long term anticoagulation (for example prosthetic mechanical heart valve); Contraindications due to local, anatomical reasons (such as thrombus in the left atrial appendage, infection with a risk of endocarditis); Allergy to apixaban; Coexisting conditions predisposing to head trauma (e.g. gait disturbances, uncontrolled seizures disorders); Chronic renal insufficiency (clearance of creatinine by Cockcroft method < 30ml/min); Patients older than 85 years; Pre-randomisation modified Rankin score of 4 or 5; Life expectancy of less than 1 year; Pregnancy or breastfeeding; CHA2DS2VASc score of 2 or 3; Patient or attending physician are unwilling to undergo/perform intervention for LAAC; Body weight lower than 50 kg; Patient or attending physician are unwilling to use of Direct OAC.