NCT03243175 Avoiding Anticoagulation After IntraCerebral Haemorrhage
| NCT ID | NCT03243175 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Lille |
| Condition | Intracerebral Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2019-01-17 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2019-01-17 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Charlotte Cordonnier, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital Lille, Inserm, Univ Lille
Frequently Asked Questions
Who can join the NCT03243175 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intracerebral Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03243175 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT03243175 currently recruiting?
Yes, NCT03243175 is actively recruiting participants. Contact the research team at charlotte.cordonnier@chru-lille.fr for enrollment information.
Where is the NCT03243175 trial being conducted?
This trial is being conducted at Lille, France, Lomme, France, Tourcoing, France.
Who is sponsoring the NCT03243175 clinical trial?
NCT03243175 is sponsored by University Hospital, Lille. The principal investigator is Charlotte Cordonnier, MD, PhD at University Hospital Lille, Inserm, Univ Lille. The trial plans to enroll 300 participants.