2024-514094-22-00招募中3 期
Avoid Anticoagulation After IntraCerebral Haemorrhage
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 33
- 主要终点
- The primary endpoint is a composite criterion including all fatal or lifethreatening and major vascular events, i.e. cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events within 24 months after randomization
研究概览
简要总结
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
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The primary endpoint is a composite criterion including all fatal or lifethreatening and major vascular events, i.e. cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events within 24 months after randomization
The primary endpoint is a composite criterion including all fatal or lifethreatening and major vascular events, i.e. cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events within 24 months after randomization
次要结局
- Each individual component of the composite outcome at 24 month after randomization (fatal or non-fatal major vascular events, i.e. cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events)
- Death of any cause at 24 months after randomization
- Functional dependence scored on the modified Rankin Scale at 24 months after randomization in a shift analysis
- Health-related quality of life measured by the EQ-5D (EuroQoL) at 24 months after randomization
- Baseline small-vessel diseases biomarkers on brain MRI (brain microbleeds, leukoaraiosis, superficial siderosis, perivascular spaces, territorial infarcts, silent macrohaemorrhages, cortical atrophy)
- Complications of endovascular treatment (up to 30 days)
- Overall evaluation of the success of the procedure (at 30 days)
研究者
Prof. Charlotte CORDONNIER
Scientific
Centre Hospitalier Universitaire De Lille
研究点 (33)
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