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RECRUITING
NCT03243175
PHASE3

Avoiding Anticoagulation After IntraCerebral Haemorrhage

Sponsor: University Hospital, Lille

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2019-01-17

Completion Date

2029-12

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DRUG

Apixaban 5 MG

Apixaban 5mg x 2 during 24 months

DEVICE

left atrial appendage closure

left atrial appendage closure

Locations (3)

Hôpital Roger Salengro, CHU

Lille, France

GHICL

Lomme, France

CH De Tourcoing

Tourcoing, France