Avoiding Anticoagulation After IntraCerebral Haemorrhage (A3ICH)
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|ClinicalTrials.gov Identifier: NCT03243175|
Recruitment Status : Recruiting
First Posted : August 8, 2017
Last Update Posted : February 18, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Intracerebral Hemorrhage Atrial Fibrillation Microhaemorrhage||Drug: Apixaban 5 MG Device: left atrial appendage closure||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||1:1:1|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||PROBE design|
|Official Title:||Avoiding Anticoagulation After IntraCerebral Haemorrhage|
|Actual Study Start Date :||January 24, 2019|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: Direct Oral Anticoagulant (DOAC)
Apixaban 5MG twice daily
Drug: Apixaban 5 MG
Apixaban 5mg x 2 during 24 months
Other Name: ELIQUIS 5mg
Experimental: Left Atrial Appendage Closure (LAAC)
Devices will be chosen by local teams.
Device: left atrial appendage closure
left atrial appendage closure
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
- Composite of all fatal or non-fatal major cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events [ Time Frame: 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.
- Each individual component of the composite outcome (fatal or non-fatal major cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events). [ Time Frame: at 12 and 24 months after randomization ]fatal or non-fatal major cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events).
- Death of any cause [ Time Frame: at 12 and 24 months after randomization ]death
- Modified Rankin Scale [ Time Frame: at 12 and 24 months after randomization ]functional dependence
- EQ-5D (EuroQoL) Score [ Time Frame: at 12 and 24 months after randomization ]health-related quality of life
- neuroradiological biomarkers [ Time Frame: Baseline ]on brain MRI
- Complications of endovascular treatment [ Time Frame: up to 30 days ]including device related complications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243175
|Contact: Charlotte Cordonnier, MD, PhD||3 20 44 68 14 ext +firstname.lastname@example.org|
|Hôpital Roger Salengro, CHU||Recruiting|
|Principal Investigator: Charlottea Cordonnier, MD,PhD|
|Principal Investigator:||Charlotte Cordonnier, MD, PhD||University Hospital Lille, Inserm, Univ Lille|