Avoiding Anticoagulation After IntraCerebral Haemorrhage (A3ICH)
Intracerebral Hemorrhage, Atrial Fibrillation, Microhaemorrhage
About this trial
This is an interventional prevention trial for Intracerebral Hemorrhage focused on measuring intracerebral hemorrhage, atrial fibrillation, microhemorrhage, oral anticoagulation, left atrial appendage closure
Eligibility Criteria
Inclusion criteria
- 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 criteria for all treatment groups
- Pre-randomisation modified Rankin score of 4 or 5
- Conditions other than atrial fibrillation for which the patient requires long term anticoagulation (for example prosthetic mechanical heart valve)
- Serious bleeding events within the 6 months before randomisation (except for intracerebral haemorrhage)
- Life expectancy of less than 1 year
- Pregnancy or breastfeeding
Exclusion criteria related to the LAAC only
- Contraindications due to local, anatomical reasons (such as thrombus in the left atrial appendage, infection with a risk of endocarditis)
- Patients older than 85 years
- CHA2DS2VASc score of 2 or 3
- Patient or attending physician are unwilling to undergo/perform intervention for LAAC
Exclusion criteria related to the Direct OAC only
- Chronic renal insufficiency (clearance of creatinine by Cockcroft method < 30ml/min)
- Body weight lower than 50 kg
- Allergy to apixaban
- Coexisting conditions predisposing to head trauma (e.g. gait disturbances, uncontrolled seizures disorders)
- Patient or attending physician are unwilling to use of Direct OAC
Sites / Locations
- Hôpital Roger Salengro, CHURecruiting
- GHICLRecruiting
- CH De TourcoingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
No Intervention
Direct Oral Anticoagulant (DOAC)
Left Atrial Appendage Closure (LAAC)
Control
Apixaban 5MG twice daily
Devices will be chosen by local teams.
avoiding anticoagulation and LAAC during the entire study period The standard clinical practice without OAC may include: antiplatelet drug (in case of comorbidities such as coronary heart disease) or no antithrombotic drug