Phase
Condition
Atrial Fibrillation
Hemorrhage
Chest Pain
Treatment
left atrial appendage closure
Apixaban 5 MG
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Design
Study Description
Connect with a study center
Hôpital Roger Salengro, CHU
Lille,
FranceActive - Recruiting
GHICL
Lomme,
FranceActive - Recruiting
CH De Tourcoing
Tourcoing,
FranceActive - Recruiting
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