NCT07026318招募中不适用
Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke: A Multicenter, Prospective, Double-blind, Vehicle-controlled, Randomized Controlled Trial
Beijing Anzhen Hospital1 个研究点 分布在 1 个国家目标入组 716 人开始时间: 2025年8月15日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 716
- 试验地点
- 1
- 主要终点
- Proportion of patients with mRS 0-2
研究概览
简要总结
This randomized controlled trial aims to evaluate whether adjunctive tirofiban therapy combined with endovascular treatment (EVT) improves neurological outcomes in patients with acute large vessel occlusion due to large-artery atherosclerosis. Patients will be randomized to receive either tirofiban or matching placebo after EVT. The primary efficacy endpoint is the proportion of patients achieving functional independence (modified Rankin Scale 0-2) at 90±7 days, while the safety endpoint is the probability of symptomatic intracranial hemorrhagewithin 48 hours after randomization.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Age ≥18 years
- •Pre-stroke modified Rankin Scale (mRS) score of 0-1
- •Acute ischemic stroke symptoms present within 24 hours of last known well time
- •Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6
- •Anterior circulation: Alberta Stroke Program Early CT Score (ASPECTS) ≥6 Posterior circulation: pc-ASPECTS ≥6
- •Occlusion of intracranial internal carotid artery (ICA), M1 segment of middle cerebral artery (MCA), V4 segment of vertebral artery, or basilar artery
- •Clinical care team plans to perform endovascular thrombectomy (EVT)
- •Subject or legally authorized representative can provide informed consent
- •Residual stenosis ≥50% without planned angioplasty/stenting
排除标准
- •Intracranial hemorrhage confirmed by imaging prior to randomization, or major intracranial hemorrhage on intraprocedural flat-panel CT
- •Gastrointestinal or genitourinary bleeding within 30 days post-stroke onset, or major surgery within 14 days
- •Bleeding diathesis including coagulopathy (platelets <100×10⁹/L, aPTT >50s, or INR >2.0), DOAC use within 48 hours, or history of HIT
- •Pregnancy or lactation at admission
- •Contraindications to radiographic contrast agents, nickel, titanium or their alloys
- •Life expectancy <6 months
- •Pre-existing neurological/psychiatric conditions that may confound assessment
- •Severe renal insufficiency (GFR <30mL/min or Scr >220μmol/L [2.5mg/dL])
- •Arterial tortuosity or anomalies preventing device delivery
- •Unlikely to complete 90-day follow-up
- •Any confirmed cardioembolic source (including atrial fibrillation, valvular disease, intracardiac thrombus, recent MI, cardiomyopathy with EF <30%, etc.)
- •Tirofiban or other GP IIb/IIIa inhibitor use before randomization or other GP IIb/IIIa inhibitor used post treatment
研究组 & 干预措施
Tirofiban group
Experimental
Receive Tirofiban treatment following endovascular therapy
干预措施: Tirofiban (Drug)
placebo group
Placebo Comparator
Receive placebo treatment after endovascular therapy.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of patients with mRS 0-2
时间窗: 90±7 days
Proportion of patients with Modified Rankin Scale (mRS) 0-2, Modified Rankin Scale（0-6）, A lower MRS score indicates better functional status for the patient.
次要结局
- Proportion of patients achieving mRS 0-3(90±7 days)
- Vascular recanalization rate assessed by CT/MR angiography(36±12 hours post-randomization)
- Incidence of Pharmacologic rescue therapy(90±7 days)
- Change in NIHSS score from baseline(36±12 hours post-randomization)
- Change in infarct volume(7±3 days post-randomization or discharge)
- Distribution of mRS scores(7±3 days/discharge；90±7 days post-randomization)
- Proportion of patients achieving mRS 0-1(90±7 days)
- Incidence of rescue therapy(90±7 days)
- EQ-5D-5L utility score(90±7 days)
- Probability of symptomatic intracranial hemorrhage(48 hours)
- All-cause mortality(90±7 days post-randomization)
- Probability of any intracranial hemorrhage(48 hours post-randomization)
研究者
研究点 (1)
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