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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03243175
Other study ID # 2016_77
Secondary ID 2017-004371-31
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 24, 2019
Est. completion date December 2026

Study information

Verified date January 2023
Source University Hospital, Lille
Contact Charlotte Cordonnier, MD, PhD
Phone 3 20 44 68 14
Email charlotte.cordonnier@chru-lille.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Exclusion criteria related to the LAAC only - Contraindications due to local, anatomical reasons (such as thrombus in the left atrial appendage, infection with a risk of endocarditis) - Patients older than 85 years - CHA2DS2VASc score of 2 or 3 - Patient or attending physician are unwilling to undergo/perform intervention for LAAC Exclusion criteria related to the Direct OAC only - Chronic renal insufficiency (clearance of creatinine by Cockcroft method < 30ml/min) - Body weight lower than 50 kg - Allergy to apixaban - Coexisting conditions predisposing to head trauma (e.g. gait disturbances, uncontrolled seizures disorders) - Patient or attending physician are unwilling to use of Direct OAC

Study Design


Intervention

Drug:
Apixaban 5 MG
Apixaban 5mg x 2 during 24 months
Device:
left atrial appendage closure
left atrial appendage closure

Locations

Country Name City State
France Hôpital Roger Salengro, CHU Lille
France GHICL Lomme
France CH De Tourcoing Tourcoing

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Lille Institut National de la Santé Et de la Recherche Médicale, France, Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
within 24 months after randomization.
Secondary 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). at 12 and 24 months after randomization
Secondary Death of any cause death at 12 and 24 months after randomization
Secondary Modified Rankin Scale functional dependence at 12 and 24 months after randomization
Secondary EQ-5D (EuroQoL) Score health-related quality of life at 12 and 24 months after randomization
Secondary neuroradiological biomarkers on brain MRI Baseline
Secondary Complications of endovascular treatment including device related complications up to 30 days
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