Intracerebral Hemorrhage, Atrial Fibrillation, Microhaemorrhage
Conditions
Keywords
intracerebral hemorrhage, atrial fibrillation, microhemorrhage, oral anticoagulation, left atrial appendage closure
Brief 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.
Detailed description
Open label randomised controlled multicentre clinical trial with masked outcome assessment (PROBE design) comparing 3 strategies (1:1:1): anticoagulation with a Direct OAC (Apixaban 5mgx2/day) vs avoid anticoagulation with left atrial appendage closure (LAAC) compared to usual care (avoid anticoagulation). Primary outcome: the net clinical benefit (composite outcome of major ischaemic and haemorrhagic events) during a follow-up of 24 months (adjudication committee masked to the randomisation arm The results of A3ICH will help the clinician to decide which strategy is the most effective in terms of benefit/risk ratio to prevent the risk of stroke or systemic embolism in patients with a history of ICH and AF. A3ICH will address this increasingly common dilemma and could affect clinical practice. Data from A3ICH will contribute to an international individual patient data meta-analysis.
Interventions
DRUGApixaban 5 MG
Apixaban 5mg x 2 during 24 months
DEVICEleft atrial appendage closure
left atrial appendage closure
Sponsors
Ministry of Health, France
Institut National de la Santé Et de la Recherche Médicale, France
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
PROBE design
Intervention model description
1:1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
for all treatment groups * 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 * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death of any cause | at 12 and 24 months after randomization | death |
| Modified Rankin Scale | at 12 and 24 months after randomization | functional dependence |
| Each individual component of the composite outcome (fatal or non-fatal major cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events). | at 12 and 24 months after randomization | fatal or non-fatal major cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events). |
| neuroradiological biomarkers | Baseline | on brain MRI |
| Complications of endovascular treatment | up to 30 days | including device related complications |
| EQ-5D (EuroQoL) Score | at 12 and 24 months after randomization | health-related quality of life |
Countries
France
Contacts
Primary ContactCharlotte Cordonnier, MD, PhD
Outcome results
None listed