ISRCTN16705062进行中（未招募）4 期
Antiplatelet Secondary Prevention International Randomised study after INtracerebral haemorrhaGe (ASPIRING): an investigator-initiated, multicentre, pragmatic, prospective, randomised, parallel group, open clinical trial of an investigational medicinal product
niversity of Edinburgh0 个研究点目标入组 4,148 人开始时间: 2024年7月15日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,148
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Stroke due to ICH, diagnosed by brain imaging, with symptom onset at least 24 hours before randomisation (i.e. there is no upper limit on the time since ICH onset)
- •2. Age =18 years at the time of first imaging diagnosis of ICH
- •3. Radiological text report of the brain imaging study that first diagnosed the ICH is available
- •4. Consent obtained from the participant (or their representative if the participant lacks mental capacity)
排除标准
- •1. ICH due to specific causes:
- •1.1. Head injury, exclusively, or
- •1.2. Secondary to aneurysm, angiitis, arteriovenous malformation/fistula, cavernous malformation, coagulopathy, intracranial venous thrombosis, moyamoya disease, or tumour at the time of consent, or
- •1.3. Haemorrhagic transformation of cerebral infarction at the time of consent.
- •2. Systolic BP =160 mmHg at randomisation.
- •3. Antithrombotic drug use:
- •3.1. Oral antiplatelet or oral anticoagulant drug, or aspirin over the counter, were taken within 24 hours before randomisation.
- •3.2. Investigator believes that prescription of a daily oral antiplatelet drug is required at the time of randomisation.
- •3.3. Use of all permitted antiplatelet drugs is contraindicated according to their representative Summary of Product Characteristics (SPC) provided with the protocol’s national addendum.
- •4. Follow-up:
- •4.1. Death appears imminent (very unlikely to survive 1 year after randomisation)
- •4.2. Follow-up will not be possible for the primary and secondary outcomes
- •5. Pregnant, breastfeeding, or of childbearing potential and not using highly effective contraception. Birth control methods which may be considered as highly effective include combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, or sexual abstinence
- •6. Previously enrolled in ASPIRING
- •7. Enrolled in a study that precludes co-enrolment with ASPIRING
研究者
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