Study of Antithrombotic Treatment After IntraCerebral Haemorrhage
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 134
- 试验地点
- 3
- 主要终点
- Fatal or non-fatal symptomatic ICH.
研究概览
简要总结
The study evaluates the effects of antithrombotic drugs (anticoagulant drugs or antiplatelet drugs) for prevention of ischaemic events in patients With recent intracerebral haemorrhage.
详细描述
Patients with spontaneous ICH have an increased risk of recurrent ICH and they also have an increased risk of ischaemic diseases. Around 40-50% of patients use, or have an indication, for antithrombotic drugs at the time of ICH. However, little is known about the benefits and harms of using antithrombotic drugs for prevention of ischaemic events in patients who have had an ICH.
There are only observational studies addressing this question. Because of the lack of randomised-controlled trials and the inconclusive findings of the observational studies, guidelines have variably endorsed both starting and avoiding antithrombotic drugs after ICH.
The investigators therefore want to study the effect and safety of using antithrombotic drugs after ICH. Furthermore, since findings on MRI can be biomarkers for subsequent bleeding, there will also be performed a sub-study of the association between such findings on MRI and risk of recurrent ICH during treatment with antithrombotic drugs.
Patients with ICH during the last 6 months and with an indication for antithrombotic drugs will be included. Patients with vascular disease and indication for antiplatelet drugs will be randomised to antiplatelet treatment vs. no antithrombotic treatment. Patients with atrial fibrillation and indication for anticoagulant treatment will be randomised to anticoagulant treatment vs. no anticoagulant treatment. The follow up period is 2 years, and the primary effect variable is new ICH. The investigators will also assess new intracranial haemorrhage, extracranial haemorrhage and ischemic events, and functional and cognitive outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age ≥18 years.
- •Spontaneous, primary ICH, of ≥1 day, but not more than 180 days after onset of qualifying ICH, i.e.:
- •No preceding traumatic brain injury, based on history from the patient/witness of spontaneous symptom onset, and brain imaging appearances consistent of spontaneous ICH (i.e. any brain/bone/soft tissue appearances of trauma must have occurred secondary to a spontaneous ICH)
- •No 'secondary' or underlying structural cause (e.g. haemorrhagic transformation of an ischaemic stroke, aneurysm, tumour, arteriovenous malformation, or intracerebral venous thrombosis)
- •Patient have indication for antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of ischaemic events, either antiplatelet drugs (for patients with vascular disease), or anticoagulant drug for patients with atrial fibrillation.
- •Consent to randomisation from the patient (or personal / legal / professional representative if the patient does not have mental capacity).
- •MRI (or CT) is performed before randomisation.
排除标准
- •Clear indication for antiplatelet or anticoagulant treatment (e.g. prosthetic heart valves).
- •Contraindications to the antithrombotic drug that will be administered.
- •Patient is pregnant, breastfeeding, or of childbearing age and not taking contraception.
- •For patients examined with MRI: Contraindication for brain MRI
- •Malignancy with life expectancy less than 2 years
研究组 & 干预措施
Antithrombotic treatment
For patients with vascular disease and indication for antiplatelet drugs: Antiplatelet drugs; For patients with atrial fibrillation and indication for anticoagulant drugs: Anticoagulant drugs
干预措施: Antithrombotic Agent (Drug)
结局指标
主要结局
Fatal or non-fatal symptomatic ICH.
时间窗: 2 years
Neurological deterioration or death associated with intracerebral haemorrhage found on CT scan, MRI, or autopsy.
次要结局
- Vascular death(2 years)
- Functional outcome(2 years)
- Death of any cause(2 years)
- Symptomatic epidural, subdural, or subarachnoid haemorrhage(2 years)
- Symptomatic major extracranial haemorrhage(2 years)
- Ischaemic events(2 years)
研究者
Torgeir Bruun Wyller
Project leader
Oslo University Hospital