Avoiding Anticoagulation After IntraCerebral Haemorrhage

Launched by UNIVERSITY HOSPITAL, LILLE · Aug 3, 2017

Keywords

ClinConnect Summary

This clinical trial, titled "Avoiding Anticoagulation After IntraCerebral Haemorrhage," is studying whether patients with a specific type of irregular heartbeat called atrial fibrillation (AF) should start taking blood-thinning medications after experiencing a brain bleed, known as intracerebral hemorrhage (ICH). These blood thinners (or anticoagulants) can help prevent strokes, but previous studies did not include patients who had a brain bleed, leaving doctors uncertain about the best treatment options for these individuals. The trial aims to determine if it is safe and beneficial for these patients to use blood thinners, undergo a procedure called left atrial appendage closure (LAAC), or avoid both treatments.

To participate in this trial, you must be an adult over 18 years old with a history of atrial fibrillation and have experienced a spontaneous brain bleed at least 14 days prior. Participants will undergo tests and discussions with their doctors to help decide the best treatment strategy for preventing future strokes. The trial is currently recruiting individuals, and it’s important to know that certain conditions, like serious bleeding problems in the last six months or being older than 85, may prevent someone from joining. This study could help clarify treatment options for those at risk of stroke after a brain bleed, making it a valuable opportunity for eligible patients.

Gender

ALL

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