Indobufen Versus Aspirin in Endovascular Unruptured Intracranial Aneurysms Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Primary Efficacy Endpoint Events: Cerebrovascular thromboembolic events occurring within 90 days postoperatively
研究概览
简要总结
This project aims to evaluate the safety and efficacy of the antiplatelet regimen combining indobufen and clopidogrel in preventing ischemic events after stent-assisted coiling embolization and flow diverter implantation for intracranial aneurysms.
Using a randomization system, patients with unruptured intracranial aneurysms scheduled for interventional treatment will be divided into an experimental group and a control group. Patients in the experimental group will be required to take indobufen (100 mg twice daily) + clopidogrel (75 mg once daily) starting 5 days before the procedure and continuing until 180 days postoperatively. Patients in the control group will be required to take aspirin (100 mg once daily) + clopidogrel (75 mg once daily) starting 5 days before the procedure and continuing until 180 days postoperatively.
An independent group of researchers will assess cerebrovascular thromboembolic events and bleeding events at different time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years (male or female);
- •Radiologically confirmed saccular intracranial aneurysm (by specialist assessment);
- •Scheduled for endovascular embolization (including: coil embolization with stent assistance or flow diversion);
- •Signed informed consent obtained.
排除标准
- •Concomitant vascular malformations, tumors, abscesses or other cerebral diseases such as multiple sclerosis;
- •Major surgery within 30 days prior to enrollment including fracture surgery or hip replacement;
- •History of ischemic stroke, ischemic heart disease or hemorrhagic disorders including intracranial hemorrhage, gastrointestinal bleeding, fundus hemorrhage or unexplained bleeding within the past 6 months;
- •Planned elective surgery within 3 months after the procedure;
- •Any hematologic disorders or inherited coagulation abnormalities;
- •Severe renal or hepatic dysfunction;
- •History of hemostatic disorders, systemic bleeding, thrombocytopenia or neutropenia;
- •History of symptomatic non-traumatic intracranial hemorrhage or cerebral amyloid angiopathy;
- •Severe cardiopulmonary diseases considered by investigators to be unsuitable for the study;
- •Women of childbearing potential with negative pregnancy test but refusing contraceptive measures, or those who are pregnant or lactating;
- •Current participation in other investigational drug or device trials.
- •Withdrawal Criteria:
- •Receiving aneurysm treatment other than coil embolization with stent assistance or flow diversion;
- •Occurrence of endpoint events during stent-assisted aneurysm embolization procedure (as adjudicated by the Clinical Events Committee), including procedure-related hemorrhagic events (aneurysm rupture, parent artery rupture, subarachnoid hemorrhage, acute ipsilateral intracerebral hemorrhage, and acute ipsilateral subdural/epidural hematoma) or ischemic events (acute large vessel occlusion, in-stent thrombosis, and diffuse ipsilateral vascular infarction caused by plaque dislodgement);
- •Device-related quality issues during stent-assisted embolization, including stent problems (stent fracture, failure to deploy properly, incomplete expansion due to product defect) and coil problems (premature detachment before intentional deployment, coil unraveling, and failure to detach);
- •Postoperative life expectancy <3 months;
- •Inability to complete 5-day premedication due to emergency surgery or other reasons;
- •Intolerance to oral antiplatelet therapy due to allergy or other contraindications.
研究组 & 干预措施
Indobufen+clopidogrel group
Patients in the experimental group will be required to take indobufen (100 mg twice daily) + clopidogrel (75 mg once daily) starting 5 days before the procedure and continuing until 180 days postoperatively.
干预措施: Indobufen treatment (Drug)
Aspirin+clopidogrel group
Patients in the control group will be required to take aspirin (100 mg once daily) + clopidogrel (75 mg once daily) starting 5 days before the procedure and continuing until 180 days postoperatively.
干预措施: Aspirin treatment (Drug)
结局指标
主要结局
Primary Efficacy Endpoint Events: Cerebrovascular thromboembolic events occurring within 90 days postoperatively
时间窗: within 90 days after endovascular treatment of unruptured intracranial aneurysms
Cerebrovascular thromboembolic events within 90 days after endovascular treatment of unruptured intracranial aneurysms, including: Ischemic stroke, Transient ischemic attack (TIA), Stent thrombosis, Emergency revascularization, Cerebrovascular death
Primary Safety Endpoint Events: Incidence of bleeding events classified as Type 2, 3, or 5 according to the Bleeding Academic Research Consortium (BARC) criteria within 90 days after endovascular treatment of unruptured intracranial aneurysms.
时间窗: Within 90 days after endovascular treatment of unruptured intracranial aneurysms.
Bleeding events classified as Type 2, 3, or 5 according to the Bleeding Academic Research Consortium (BARC) criteria within 90 days after endovascular treatment of unruptured intracranial aneurysms.
次要结局
- Cerebrovascular thromboembolic events occurring within 30 days postoperatively(Within 30 days postoperatively)
- Cerebrovascular thromboembolic events occurring within 180 days postoperatively(Within 180 days postoperatively)
- Platelet aggregation rate within 24 hours before surgery(Within 24 hours before surgery)
研究者
Wang Shuo
Director of Department of Cerebrovascular Neurosurgery
Beijing Tiantan Hospital