Avoiding Anticoagulation After IntraCerebral Haemorrhage
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Apixaban 5 MG
- left atrial appendage closure
Treatment groups
300 Participants
are divided into 3 treatment groupsSponsors and collaborators
University Hospital, Lille
Lead sponsor
Ministry of Health, France
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
Source ClinicalTrials.gov