Avoiding Anticoagulation After IntraCerebral Haemorrhage

  • STATUS
    Recruiting
  • End date
    Dec 25, 2023
  • participants needed
    300
  • sponsor
    University Hospital, Lille
Updated on 25 January 2021
electrocardiogram
stroke
anticoagulants
fibrillation
vitamin k antagonist
intracerebral hemorrhage
brain ct
vitamin k
apixaban
left atrial appendage closure
embolism
anticoagulation therapy
equipoise

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.

Details
Condition Arrhythmia, Atrial Fibrillation, Cerebral Hemorrhage, Atrial Fibrillation (Pediatric), Microhaemorrhage, Dysrhythmia, intracerebral hemorrhage, intracerebral haemorrhage, hemorrhage cerebral, intracerebral hemorrhage (ich), cerebral bleeding
Treatment Left atrial appendage closure, Apixaban 5 mg
Clinical Study IdentifierNCT03243175
SponsorUniversity Hospital, Lille
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Arrhythmia or Dysrhythmia or Atrial Fibrillation or Microhaemorrhage or Cerebral Hemorrhage or Atrial Fibrillation (Pediatric)?
Do you have any of these conditions: Cerebral Hemorrhage or Microhaemorrhage or intracerebral hemorrhage or Atrial Fibrillation (Pediatric) or cerebral bleeding or Arrhythmia or intracere...?
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
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