Status:
RECRUITING
Avoiding Anticoagulation After IntraCerebral Haemorrhage
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Ministry of Health, France
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Intracerebral Hemorrhage
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
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 avoi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03243175
Start Date
January 17 2019
End Date
December 1 2028
Last Update
February 6 2025
Active Locations (3)
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1
Hôpital Roger Salengro, CHU
Lille, France
2
GHICL
Lomme, France
3
CH De Tourcoing
Tourcoing, France