Avoiding Anticoagulation After IntraCerebral Haemorrhage

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Lille
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Ministry of Health, France
• Treatments: Apixaban

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