Avoiding Anticoagulation After IntraCerebral Haemorrhage

Who is this study for? Patients with atrial fibrillation after and intracerebral hemorrhage
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Hôpital Roger Salengro, CHU
RECRUITING
Lille
GHICL
RECRUITING
Lomme
CH De Tourcoing
RECRUITING
Tourcoing
Contact Information
Primary
Charlotte Cordonnier, MD, PhD
charlotte.cordonnier@chru-lille.fr
3 20 44 68 14
Time Frame
Start Date: 2019-01-17
Estimated Completion Date: 2028-12
Participants
Target number of participants: 300
Treatments
Experimental: Direct Oral Anticoagulant (DOAC)
Apixaban 5MG twice daily
Experimental: Left Atrial Appendage Closure (LAAC)
Devices will be chosen by local teams.
No_intervention: Control
avoiding anticoagulation and LAAC during the entire study period The standard clinical practice without OAC may include: antiplatelet drug (in case of comorbidities such as coronary heart disease) or no antithrombotic drug
Related Therapeutic Areas
Sponsors
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France, Ministry of Health, France
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov