Avoiding Anticoagulation After IntraCerebral Haemorrhage

Open label randomised controlled multicentre clinical trial with masked outcome assessment (PROBE design) comparing 3 strategies (1:1:1): anticoagulation with a Direct OAC (Apixaban 5mgx2/day) vs avoid anticoagulation with left atrial appendage closure (LAAC) compared to usual care (avoid anticoagulation).

Primary outcome: the net clinical benefit (composite outcome of major ischaemic and haemorrhagic events) during a follow-up of 24 months (adjudication committee masked to the randomisation arm

The results of A3ICH will help the clinician to decide which strategy is the most effective in terms of benefit/risk ratio to prevent the risk of stroke or systemic embolism in patients with a history of ICH and AF. A3ICH will address this increasingly common dilemma and could affect clinical practice.

Data from A3ICH will contribute to an international individual patient data meta-analysis.

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