Prophylactic Administration of Tirofiban for Preventing Thromboembolic Events in Stent-assisted Coiling and Flow Diversion Treatments of Unruptured Intracranial Aneurysms
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- The numbers of ischemic lesions on diffusion weighted imaging within 48 hours after procedure.
研究概览
简要总结
To explore whether administering tirofiban in stent-assisted coiling/flow diverting treatments for participants with unruptured intracranial aneurysms can reduce new ischemic lesions on postoperative DWI sequences compared to conventional dual antiplatelet therapy.
详细描述
Participants with stent-assisted coiling/flow diverting for unruptured intracranial aneurysms will be enrolled and randomized into two groups: Tirofiban group-after femoral artery puncture, initial infusion of 0.4μg/kg body weight/minute over 30 minutes, followed by a continuous infusion of 0.1μg/kg body weight/minute for 24 hours. Meanwhile, routine dual antiplatelet therapy (aspirin 100 mg/day, clopidogrel 75 mg/day) will be administered. Placebo group-100 mg/day aspirin and 75 mg/day clopidogrel. The primary effectiveness endpoint is the numbers and volumes of ischemic lesions on diffusion weighted imaging (DWI) within 48 hours after procedure.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with unruptured cerebral aneurysms eligible for stent-assisted coiling or flow diversion devices.
- •Completion of preoperative antiplatelet preparation.
- •Signed informed consent.
排除标准
- •Abnormal platelet count (normal reference is 100-300×10^9/L).
- •Allergy to study drugs and anesthetics.
- •Contradictory to MRI examination.
- •Known history of intracranial tumor, arteriovenous malformation, arteriovenous fistula, venous sinus thrombosis, hereditary cerebral small vessel disease, peripheral hemangioma (e.g., aortic aneurysm, limb vascular aneurysm).
- •Known history of cerebral parenchymal hemorrhage, subarachnoid hemorrhage, cerebral infarction, transient ischemic attack, or gastrointestinal bleeding within 6 months.
- •Clear indications for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis).
- •Antiplatelet drug (exclude aspirin and clopidogrel) being taken within 72 hours; anticoagulant drug (including heparin or oral anticoagulants) being taken within 10 days;
- •Participants with recurrent aneurysms who have received neurointerventional treatment.
- •Inability to follow endovascular procedures due to anatomical difficulties.
- •Severe renal (creatinine exceeding 1.5 times of the upper limit of normal range) or hepatic (ALT or AST > twice the upper limit of normal range) insufficiency.
- •Severe heart failure (NYHA classes III and IV) or severe arrhythmias, including sick sinus syndrome, severe atrioventricular block, and bradycardia-related syncope.
研究组 & 干预措施
Tirofiban group
After femoral artery puncture, initial infusion of 0.4μg/kg body weight/minute over 30 minutes, followed by a continuous infusion of 0.1μg/kg body weight/minute for 24 hours.
干预措施: Tirofiban (Drug)
Tirofiban group
After femoral artery puncture, initial infusion of 0.4μg/kg body weight/minute over 30 minutes, followed by a continuous infusion of 0.1μg/kg body weight/minute for 24 hours.
干预措施: aspirin, clopidogrel (Drug)
Standard medical care
Routine dual antiplatelet therapy (aspirin 100 mg/day, clopidogrel 75 mg/day)
干预措施: aspirin, clopidogrel (Drug)
结局指标
主要结局
The numbers of ischemic lesions on diffusion weighted imaging within 48 hours after procedure.
时间窗: within 48 hours after procedure
The volumes of ischemic lesions on diffusion weighted imaging within 48 hours after procedure.
时间窗: within 48 hours after procedure
次要结局
- Any new stroke events (ischemic stroke or hemorrhagic stroke) within 48-hour and 30-day after procedure.(at postoperative 48-hour and 30-day)
- Incidence of ischemic stroke within 48-hour and 30-day after procedure.(at postoperative 48-hour and 30-day)
- Incidence of transient ischemic attack within 48-hour and 30-day after procedure.(at postoperative 48-hour and 30-day)
- Incidence of ischemic stroke and transient ischemic attack within 48-hour and 30-day after procedure.(at postoperative 48-hour and 30-day)
- Disabling stroke within 30-day after procedure.(at postoperative 30-day)