ISRCTN71907627已完成未知
REstart or STop Antithrombotics Randomised Trial
niversity of Edinburgh (UK) and NHS Lothian0 个研究点目标入组 537 人开始时间: 2013年4月25日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 537
研究概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29506580 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31128924 results (added 29/05/2019) 2019 Other publications in https://pubmed.ncbi.nlm.nih.gov/31129065/ subgroup analyses (added 17/02/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34103345/ (added 10/06/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34477823/ Extended Follow-up (added 06/09/2021) 2021 Abstract results in https://doi.org/10.1177/23969873211034932 Results abstract of extended follow-up European Stroke Organisation Conference 2021 (added 29/03/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patient age 18 years or over, either sex
- •2. Spontaneous intracerebral haemorrhage (ICH) not attributable to preceding traumatic brain injury, on the basis of:
- •2.1. A history from the patient/witness of spontaneous symptom onset without preceding head trauma (head trauma occurring subsequent to ICH symptom onset is permissible)
- •2.2. brain imaging appearances consistent with spontaneous ICH (which may be accompanied by the brain/bone/soft tissue appearances of trauma occurring subsequently)
- •2.3. Either '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)
- •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 at least 24 hours after ICH symptom onset (randomisation is expected to usually occur when they are 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.
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 taking an anticoagulant drug following ICH
- •4. Patient is pregnant, breastfeeding, or of childbearing age and not taking contraception
- •5. Patient is being treated or followed up in another Clinical Trial of an Investigational Medicinal Product (CTIMP)
- •6. Patient and carer unable to understand spoken or written English (local translator is not available)
- •7. 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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