Informations générales (source: ClinicalTrials.gov)
Avoiding Anticoagulation After IntraCerebral Haemorrhage (A3ICH)
Interventional
Phase 3
University Hospital, Lille (Voir sur ClinicalTrials)
janvier 2019
décembre 2028
05 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | BERTRAND LAPERGUE | 05/05/2025 07:11:58 | Contacter | ||
| HOPITAL FONDATION A. DE ROTHSCHILD | Michaël OBADIA | 21/06/2024 13:32:48 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH De Tourcoing - Tourcoing - France | Contact (sur clinicalTrials) | ||||
| GHICL - Lomme - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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