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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Apixaban 5 MG
DrugApixaban 5mg x 2 during 24 months
left atrial appendage closure
Deviceleft atrial appendage closure
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: Direct Oral Anticoagulant (DOAC)Experimental treatment 1 intervention
Group B: Left Atrial Appendage Closure (LAAC)Experimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Composite of all fatal or non-fatal major cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events
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.
Time frame
within 24 months after randomization.Secondary outcomes
1
Each individual component of the composite outcome (fatal or non-fatal major cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events).
fatal or non-fatal major cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events).
Time frame
at 12 and 24 months after randomization2
Death of any cause
death
Time frame
at 12 and 24 months after randomization3
Modified Rankin Scale
functional dependence
Time frame
at 12 and 24 months after randomization4
EQ-5D (EuroQoL) Score
health-related quality of life
Time frame
at 12 and 24 months after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
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