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Recruiting Phase 3

Avoiding Anticoagulation After IntraCerebral Haemorrhage

NCT03243175 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2019-01-17
Last updated
2026-04-07

Condition(s) studied

Intracerebral HemorrhageAtrial FibrillationMicrohaemorrhage

Investigational drug(s) / intervention(s)

Apixaban 5 MG →left atrial appendage closure

Apixaban 5 MG: Apixaban 5mg x 2 during 24 months

left atrial appendage closure: left atrial appendage closure

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Composite of all fatal or non-fatal major cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events — within 24 months after randomization.
    The composite endpoint will enable to evaluate the net clinical benefit of the different therapeutic strategies. Definition of fatal event: when death is occurring within 30 days after the events.

Trial sites (3)

FacilityCityRegionStatus
Hôpital Roger Salengro, CHU Lille France Recruiting
GHICL Lomme France Recruiting
CH De Tourcoing Tourcoing France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03243175 on ClinicalTrials.gov ↗ ← All trials in France