BridgeMD
Avoid Anticoagulation After IntraCerebral Haemorrhage
EU CTIS ID: 2024-514094-22-00
What this study is testing
To assess the efficacy of the strategy "Direct OAC" or "avoiding OAC with LAAC" compared to "usual care (avoiding anticoagulation and LAAC)" on individual component of the net clinical benefit, mortality, dependency and health-related quality
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult (older than 18 years old, no upper age limit)
- With a history of paroxysmal, persistent or long-standin g non-valvular atrial fibrillation (documented on an electrocardiogram)
- And a CHA2DS2VASc (22) 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 1 month (more precisely 30 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.
You likely can't join if
- Severe chronic renal insufficiency (clearance of creatinine < 15ml/min)
- (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)
- (Exclusion criteria related to the LAAC only): Patients older than 85 years
- (Exclusion criteria related to the LAAC only): CHA2DS2VASc score of 2 or 3
- (Exclusion criteria related to the LAAC only): Any other contraindication according to the health care team
- (Exclusion criteria related to the Direct OAC only): Allergy to apixaban
See the full eligibility criteria
- Adult (older than 18 years old, no upper age limit)
- With a history of paroxysmal, persistent or long-standin g non-valvular atrial fibrillation (documented on an electrocardiogram)
- And a CHA2DS2VASc (22) 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 1 month (more precisely 30 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.
- Being affiliated to the Sécurité Sociale
- Severe chronic renal insufficiency (clearance of creatinine < 15ml/min)
- (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)
- (Exclusion criteria related to the LAAC only): Patients older than 85 years
- (Exclusion criteria related to the LAAC only): CHA2DS2VASc score of 2 or 3
- (Exclusion criteria related to the LAAC only): Any other contraindication according to the health care team
- (Exclusion criteria related to the Direct OAC only): Allergy to apixaban
- (Exclusion criteria related to the Direct OAC only): Coexisting conditions predisposing to head trauma (e.g. gait disturbances, uncontrolled seizures disorders)
- (Exclusion criteria related to the Direct OAC only): Any other contraindication according to the health care team
- Pre-randomisation modified Rankin (2) 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
- Woman of childbearing age not taking effective contraception
- People under guardianship, trusteeship, deprive of freedom
- Any other contraindication according to the health care team
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.