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. 2023 Jan 26;2023(1):CD012144. doi: 10.1002/14651858.CD012144.pub3

NCT03243175.

Study name Avoiding Anticoagulation After IntraCerebral Haemorrhage (A3ICH)
Methods Design: randomised controlled PROBE 3‐arm trial (1:1:1)
Setting: multicentre, France
Dates: January 2019 to December 2023
Participants Sample size: 300 participants
Diagnosis: ICH
Inclusion criteria

  • Adult (older than 18 years old, no upper age limit);

  • with a history of paroxysmal, persistent or long‐standing non‐valvular AF (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 ICH (while being treated with oral anticoagulants or not) documented with brain CT or MRI;

  • more than 14 days before randomisation (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 mRS of 4 or 5

  • Conditions other than AF for which the patient requires long term anticoagulation (fe.g. prosthetic mechanical heart valve)

  • Serious bleeding events within the 6 months before randomisation (except for ICH)

  • Life expectancy of less than 1 year

  • Pregnancy or breastfeeding


Exclusion criteria related to LAAO 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

  • Patient or attending physician are unwilling to undergo/perform LAAO


Exclusion criteria related to DOAC only

  • Chronic renal insufficiency (clearance of creatinine by Cockcroft method < 30 mL/min)

  • Body weight lower than 50 kg

  • Allergy to apixaban

  • Coexisting conditions predisposing to head trauma (e.g. gait disturbance, uncontrolled seizures disorder)

  • Patient or attending physician are unwilling to use DOAC
Interventions Intervention: apixaban 5mg twice daily
Intervention: LAAO
Comparator: no OAC or LAAO. May include antiplatelet agents (in the setting of co‐morbidities) or no antithrombotic drugs at all
Outcomes Primary outcome

  • Composite of all fatal or non‐fatal major cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events


Secondary outcomes

  • Each individual component of the composite outcome (fatal or non‐fatal major cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events)

  • Death of any cause

  • mRS

  • EQ‐5D (EuroQoL) Score

  • Complications of LAAO up to 30 days including device related complications


Duration of follow‐up: 2 years
Starting date 24 January 2019
Contact information Prof Charlotte Cordonnier, MD, PhD
e‐mail: charlotte.coprdonnier@chru‐lille.fr
Notes Declarations of interest: not specified in trials register
Sources of funding: not specified in trials register