Avoiding Anticoagulation After IntraCerebral Haemorrhage
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Hôpital Roger Salengro, CHU | Lille | France | Recruiting |
| GHICL | Lomme | France | Recruiting |
| CH De Tourcoing | Tourcoing | France | Recruiting |
More University Hospital, Lille trials in France
Other trials for the same condition
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