NCT03243175RecruitingPhase 3
Avoiding Anticoagulation After IntraCerebral Haemorrhage
Source: ClinicalTrials.gov · Last updated 7 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 3 Aug 2017
- Start date
- 17 Jan 2019
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- University Hospital, Lille
- Diseases
- Atrial fibrillation
- NCT number
- NCT03243175
- EudraCT number
- 2017-004371-31
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 300
- From 17 Jan 2019 to the primary completion date, 31 Jan 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Serious bleeding events within the 6 months before randomisation (except for intracerebral haemorrhage)
Other illness
- 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)
Lab values
- Chronic renal insufficiency (clearance of creatinine by Cockcroft method \< 30ml/min)
Age
- Patients older than 85 years
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Roger Salengro, CHU Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| GHICL Coordinator of this site? Confirm its status | Lomme | France | Recruiting |
| CH De Tourcoing Coordinator of this site? Confirm its status | Tourcoing | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.