NCT07135089招募中3 期
Improving Neuroprotective Strategy for Ischemic Stroke Before Endovascular Thrombectomy by Intravenous Tirofiban (INSIST-IT2): a Prospective, Randomized, Double Blinded, Multi-center Study
General Hospital of Shenyang Military Region1 个研究点 分布在 1 个国家目标入组 870 人开始时间: 2025年11月13日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 870
- 试验地点
- 1
- 主要终点
- The proportion of patients with functional independence (modified Rankin Scale [mRS] score of 0 to 2)
研究概览
简要总结
It remains uncertain whether intravenous tirofiban administered before endovascular thrombectomy could improve disability severity for patients with LVO due to intracranial atherosclerosis.The current study aimed to assess the efficacy and safety of administering intravenous tirofiban before endovascular thrombectomy for improving clinical outcomes in patients with anterior circulation LVO due to intracranial atherosclerosis.
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;
- •Anterior circulation large vessel occlusion (the internal carotid artery or the first or second segment of the middle cerebral artery) confirmed by computed tomography angiography (CTA) or magnetic resonance angiography (MRA);
- •Eligible for endovascular treatment within 12 hours of symptom onset;
- •Based on the patient's medical history, clinical presentation, and imaging findings, large artery atherosclerosis is highly suspected as the underlying etiology;
- •Baseline National Institute of Health Stroke Scale (NIHSS) ≥ 6;
- •Baseline ASPECTS ≥ 6 on CT;
- •A pre-stroke modified Rankin Scale (mRS) score of ≤2;
- •Signed informed consent by patient or their legally authorized representative.
排除标准
- •History of atrial fibrillation or atrial flutter, or 12-lead Electrocardiogram before randomization and after admission showing atrial flutter or atrial fibrillation;
- •Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage, or a history of bleeding within one month;
- •Intracranial aneurysms or malformations, tortuous arteries that hinder thrombectomy, and space-occupying effect brain tumors;
- •The following drugs are taken within one week: dual antiplatelet drugs, direct oral anticoagulants (DOACs), warfarin and other drugs that increase the risk of bleeding;
- •Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
- •Deficiency of anticoagulant factors or international normalized ratio (INR) > 1.7, platelet count < 90×10⁹/L;;
- •Severe renal insufficiency and advanced disease with an expected life expectancy of less than 6 months;
- •Pregnancy or lactation;
- •Allergy to drugs or contrast agents;
- •Participating in other clinical trials;
- •Other conditions that the researcher deems unsuitable for participation in this study.
研究组 & 干预措施
Tirofiban group
Experimental
Intravenous tirofiban before endovascular thrombectomy
干预措施: Intravenous tirofiban before endovascular thrombectomy (Drug)
Placebo group
Placebo Comparator
Intravenous placebo before Endovascular Thrombectomy
干预措施: Intravenous placebo before endovascular thrombectomy (Drug)
结局指标
主要结局
The proportion of patients with functional independence (modified Rankin Scale [mRS] score of 0 to 2)
时间窗: Day 90
mRS ranges from 0-6, with high score meaning poor outcome
次要结局
- The proportion of patients without disability (modified Rankin Scale [mRS] score of 0 to 1) or who returned to their premorbid mRS score at 90 days (for patients with prestroke mRS score >1)(Day 90)
- ordinal distribution of modified Rankin Scale (mRS)(Day 90)
- The proportions of patients with substantial reperfusion at initial preprocedure catheter angiogram (defined as mTICI score ≥2b)(immediately after first catheter angiogram)
- The proportions of patients with substantial reperfusion at final angiogram(immediately after final angiogram)
- The proportions of patients with complete recanalization as assessed by CTA or MRA 48 hours after endovascular treatment(24 (-6/+24) hours)
- Change in National Institute of Health stroke scale (NIHSS)(24 (-6/+24) hours)
- change in National Institute of Health stroke scale (NIHSS)(7 (-2/+2) days)
- The incidence of symptomatic intracranial hemorrhage assessed according to Heidelberg bleeding classification(24 (-6/+24) hours)
- The incidence of intraparenchymal hemorrhage (PH1 and PH2)(24 (-6/+24) hours)
- The incidence of non-intracranial hemorrhage complications(24 (-6/+24) hours)
- Serious adverse events(7 (-2/+2) days)
- Procedure-associated complications(Periprocedural)
- The proportion of patients with thrombocytopenia(24 (-6/+24) hours)
- The incidence of mortality(Day 90)
研究者
Hui-Sheng Chen
Director
General Hospital of Shenyang Military Region
研究点 (1)
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