Under construction – not a live service
Sign in
Taking people in FrancePhase 3

Blood thinner or heart appendage closure after brain bleeding with atrial fibrillation

Tests apixaban or appendage closure, or neither, in adults with brain bleeding.

Key facts

Who runs it
University Hospital, Lille
Where
Lille, Lomme, and Tourcoing, FranceSee the 3 sites
Registry title
Avoiding Anticoagulation After IntraCerebral Haemorrhage
Status
Recruiting
Phase
Phase 3
People taking part
300 people, planned
Started
17 Jan 2019
Expected to end
Dec 2029
Type of study
Interventional, 3 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Apixaban 5 MG
  • left atrial appendage closure
Record updated
7 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with atrial fibrillation who had a spontaneous bleed in the brain more than 14 days ago and need long-term blood thinners.

Age
Adults older than 18 years, no upper age limit.
Sex
All sexes can join.
Disease stage
Non-valvular atrial fibrillation (paroxysmal, persistent or long-standing) documented on an electrocardiogram, with a CHA2DS2VASc score of 2 or more. A spontaneous bleed in the brain seen on CT or MRI, more than 14 days before randomization.
Earlier treatment
The brain bleed can have happened with or without oral anticoagulant treatment.

Main reasons for not taking part

  • Modified Rankin score of 4 or 5 before randomisation
  • Another condition needing long-term anticoagulation, such as a mechanical heart valve
  • Serious bleeding within the 6 months before randomisation (other than the brain bleed)
  • Life expectancy of less than 1 year
  • Pregnancy or breastfeeding

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Serious bleeding events within the 6 months before randomisation (except for intracerebral haemorrhage)
  • Conditions other than atrial fibrillation for which the patient requires long term anticoagulation (for example prosthetic mechanical heart valve)
  • Contraindications due to local, anatomical reasons (such as thrombus in the left atrial appendage, infection with a risk of endocarditis)
  • Allergy to apixaban
  • Coexisting conditions predisposing to head trauma (e.g. gait disturbances, uncontrolled seizures disorders)
  • Chronic renal insufficiency (clearance of creatinine by Cockcroft method < 30ml/min)
  • Patients older than 85 years
  • Pre-randomisation modified Rankin score of 4 or 5
  • Life expectancy of less than 1 year
  • Pregnancy or breastfeeding
  • CHA2DS2VASc score of 2 or 3
  • Patient or attending physician are unwilling to undergo/perform intervention for LAAC
  • Body weight lower than 50 kg
  • Patient or attending physician are unwilling to use of Direct OAC

Where in France

  • Hôpital Roger Salengro, CHULille, FranceContact: Charlottea Cordonnier, MD,PhD (principal investigator)Taking people
  • GHICLLomme, FranceContact: Marta PASQUINI, MD (principal investigator)Taking people
  • CH De TourcoingTourcoing, FranceContact: Frédéric DUMONT, MD (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 3 groups in the trial

  • Direct Oral Anticoagulant (DOAC)Treatment being tested

    Apixaban 5MG twice daily

    Treatment: Apixaban 5 MG

  • Left Atrial Appendage Closure (LAAC)Treatment being tested

    Devices will be chosen by local teams.

    Treatment: left atrial appendage closure

  • ControlNo study treatment, for comparison

    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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Avoiding Anticoagulation After IntraCerebral Haemorrhage
Plain-language title
Blood thinner or heart appendage closure after brain bleeding with atrial fibrillationGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
7 April 2026