Avoiding Anticoagulation After IntraCerebral Haemorrhage

Phase 3

Recruiting

• Conditions: Intracerebral Hemorrhage; Atrial Fibrillation; Microhaemorrhage
• Interventions: Drug: Apixaban 5 MG; Device: left atrial appendage closure

• Registration Number: NCT03243175
• Lead Sponsor: University Hospital, Lille

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.

Study Timeline

• Study First Submitted: 2017-08-03
• Study First Submitted QC: 2017-08-03
• Study First Posted: 2017-08-08
• Study Start: 2019-01-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-06
• Primary Completion: 2026-01
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct Oral Anticoagulant (DOAC)	Apixaban 5 MG	Apixaban 5MG twice daily
Left Atrial Appendage Closure (LAAC)	left atrial appendage closure	Devices will be chosen by local teams.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (3)

GHICL; 🇫🇷 Lomme, France

CH De Tourcoing; 🇫🇷 Tourcoing, France

Hôpital Roger Salengro, CHU; 🇫🇷 Lille, France