An Investigator Initiated and Conducted, Prospective, Multicentre, Randomised Outcome-blinded Pilot Study of Antiplatelet Therapy in Patients with a History of Stroke Due to Intracerebral Haemorrhage
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- regulatory approvals
研究概览
简要总结
ASPIRING is an investigator-led, multicentre, prospective, randomised, open-label, blind outcome (PROBE), parallel group, clinical trial. The pilot phase will explore the feasibility of conducting a trial of starting antiplatelet monotherapy versus avoiding antiplatelet therapy for reducing all serious vascular events for adults surviving symptomatic stroke due to spontaneous intracerebral haemorrhage (ICH). The pilot phase will involve ~120 patients at ~30 hospitals in China, Australia and New Zealand.
详细描述
The participant eligibility criteria specifically identify adults with history of symptomatic spontaneous ICH. Randomisation occurs if a participant and their doctor are uncertain about whether to start or avoid antiplatelet monotherapy at least 24 hours after ICH symptom onset. The intervention is a pragmatic policy of starting antiplatelet monotherapy (one antiplatelet drug available in local standard clinical practice, chosen by patient's physician pre-randomisation). The control group adopts a policy of avoiding antiplatelet therapy.
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.
- •Symptomatic stroke due to spontaneous (non-traumatic) ICH.
- •Patient is at least 24 hours after ICH symptom onset.
- •Patient and their doctor are both uncertain about whether to start or avoid antiplatelet monotherapy.
- •Consent to randomisation from the patient (or personal / legal / professional representative if the patient does not have mental capacity).
排除标准
- •ICH due to head injury, in the opinion of the investigator.
- •ICH due to haemorrhagic transformation of an ischaemic stroke, in the opinion of the investigator.
- •Patient is already taking antiplatelet therapy, or full dose anticoagulant therapy, after ICH.
- •Patient is pregnant, breastfeeding, or of childbearing age and not taking contraception.
- •Patient and carer unable to understand spoken or written local language.
研究组 & 干预措施
Intervention
Start antiplatelet monotherapy (one antiplatelet drug available in local standard clinical practice, chosen by patient's physician pre-randomisation).
干预措施: Start antiplatelet monotherapy (Drug)
结局指标
主要结局
regulatory approvals
时间窗: 6 months
Receipt of regulatory approvals in China，Australia and New Zealand separately, including Ethics, Human Genetics Resources Administration of China (HGRAC).
次要结局
- Completeness of follow-up assessments(3 years)
- Serious adverse event (SAE)(at least 6 months)
- Adherence to the allocated intervention by investigators and participants(3 years)
- Characteristics of randomised participants compared with eligible patients who were not recruited.(3 years)
- Frequency of protocol deviations and violations.(3 years)
- Frequency of the composite of all serious vascular events(6 months)
- trial database(6 months)
- Site recruitment(12-18 month)
- Barriers to randomisation of eligible patients.(3 years)
- Calculate frequency of clinical data(3 years)
- Frequency of withdrawal and loss to follow-up(3 years)
- Serious adverse reaction (SAR)(at least 6 months)
- Suspected Unexpected Serious Adverse Reaction (SUSAR)(at least 6 months)