EUCTR2012-003190-26-GB进行中（未招募）不适用
REstart or STop Antithrombotics Randomised Trial (RESTART) - REstart or STop Antithrombotics Randomised Trial (RESTART)
ACCORD (Academic and Clinical Central Office for Research & Development)0 个研究点目标入组 720 人开始时间: 2012年11月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 720
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patient age =18 years.
- •2. Spontaneous ICH
- •o not attributable to preceding traumatic brain injury, on the basis of:
- •?a history from the patient/witness of spontaneous symptom onset without preceding head trauma (head trauma occurring subsequent to ICH symptom onset is permissible)
- •?brain imaging appearances consistent with spontaneous ICH (which may be accompanied by the brain/bone/soft tissue appearances of trauma occurring subsequently)
- •oeither ‘secondary’ to an underlying structural cause (e.g. aneurysm, tumour, arteriovenous malformation, or intracranial venous thrombosis), or ‘primary’ (if the investigator either does not suspect an underlying structural cause, or it is not detected by further radiographic investigation).1,44
- •3. Patient had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease for any length of time before the onset of the qualifying ICH.
- •4. Patient is approaching the end of their hospital admission/assessment for the qualifying ICH.
- •5. Patient and their doctor are both uncertain about whether to start or avoid antiplatelet drugs.
- •6. Patient is registered with a general practitioner (GP).
- •7. Brain imaging study that first diagnosed the qualifying ICH is available.
- •8. Consent to randomisation from the patient (or personal / legal / professional representative if the patient does not have mental capacity).
- •9. If eligible for the brain MRI sub-study, the MRI must be performed after the ICH but before randomisation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 470
排除标准
- •1. ICH due to traumatic brain injury, in the opinion of the investigator.
- •2. ICH due to haemorrhagic transformation of an ischaemic stroke, in the opinion of the investigator.
- •3. Patient is pregnant, breastfeeding, or of childbearing age and not taking contraception.
- •4. Patient is being treated or followed up in another CTIMP.
- •5. Patient and carer unable to understand spoken or written English (and local translator is not available).
- •6. Patients are ineligible for the brain MRI sub-study if they are claustrophobic or they have a contraindication to MRI.
研究者
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