NCT07263776进行中（未招募）3 期
Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Anterior Circulation Large Vessel Occlusion Stroke: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial-2 (IRIS-2)
Capital Medical University54 个研究点 分布在 1 个国家目标入组 692 人开始时间: 2025年12月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 692
- 试验地点
- 54
- 主要终点
- modified Rankin Scale (mRS) score at 90 days
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled clinical trial. Investigators aim to assess the efficacy and safety of interleukin-6 receptor inhibitor combined with endovascular treatment in patients with acute anterior circulation large vessel occlusion stroke.
详细描述
The study population are patients with acute anterior circulation large vessel occlusion stroke and planned to undergo endovascular treatment. All participants are randomly assigned in a 1:1 ratio to the tocilizumab group or the placebo group. In tocilizumab group, participants will receive tocilizumab combined endovascular treatment. And in placebo group, participants will receive placebo combined endovascular treatment. All participants will be visited immediately postoperatively, at 24 hours, 7 days, and 90 days 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 or greater, male or female;
- •Acute ischemic stroke caused by occlusion of intracranial segment of the internal carotid artery, middle cerebral artery M1 or proximal/dominant M2 segment;
- •Decided to undergo emergency endovascular treatment;
- •Time from stroke onset to arterial puncture within 24 hours;
- •National Institutes of Health Stroke Scale (NIHSS) score ≥ 6;
- •Signed informed consent from the patients or the legally authorized representatives.
排除标准
- •Intracerebral hemorrhage, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage;
- •Pre-stroke modified Rankin scale (mRS) score >1;
- •Known allergy to tocilizumab or excipients;
- •Known allergy to iodinated contrast agents;
- •Anticipated difficulty in completing endovascular treatment due to vascular tortuosity;
- •History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, or thrombocytopenic diseases;
- •Systolic blood pressure ≥180mmHg or diastolic blood pressure ≥110mmHg despite blood pressure control;
- •Neutrophils <2×109 /L;
- •Platelets <100×109 /L;
- •Blood glucose <2.8mmol/L (50 mg/dL) or >22.2mmol/L (400 mg/dL);
- •Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >2 times the upper limit of normal;
- •Known recent or current serum creatinine >2 times the upper limit of normal or estimated glomerular filtration rate (eGFR) <60 mL/min;
- •Pregnant, lactating, or planning pregnancy within 90 days;
- •Severe mental disorders or inability to comply with informed consent and follow-up requirements due to dementia;
- •Concurrent malignant tumors or severe systemic diseases with expected survival of less than 90 days;
- •Presence of autoimmune diseases or use of immunosuppressive drugs;
- •Systemic infectious diseases;
- •Participation in another interventional clinical study within 30 days before randomization or currently participating in another interventional clinical study;
- •Considered by the investigator to have other conditions that might affect compliance or preclude participation in this study.
研究组 & 干预措施
Placebo group
Placebo Comparator
Endovascular treatment combined equivalent volume of placebo once.
干预措施: Placebo (Drug)
Tocilizumab group
Experimental
Endovascular treatment combined 240 mg tocilizumab injection once.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
modified Rankin Scale (mRS) score at 90 days
时间窗: 90 days
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
次要结局
- Incidence of symptomatic intracerebral hemorrhage within 24 hours(24 hours)
- Incidence of any intracerebral hemorrhage within 24 hours(24 hours)
- Proportion of patients with mRS score 0-2 at 90 days(90 days and 1year)
- Proportion of patients with mRS score 0-1 at 90 days(90 days and 1year)
- EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) at 90 days(90 days and 1year)
- Proportion of Barthel Index (BI) 95-100 at 90 days(90 days and 1year)
- Mortality at 90 days(90 days and 1year)
- National Institutes of Health Stroke Scale (NIHSS) score at 7 days or at early discharge(7 days or at early discharge)
- Incidence of symptomatic intracerebral hemorrhage within 24 hours(24 hours)
- Incidence of any intracerebral hemorrhage within 24 hours(24 hours)
- Proportion of patients with pneumonia at 7 days or at early discharge(7 days or at early discharge)
- Infarct volume at 24 hours(24 hours)
研究者
Ji Xunming,MD,PhD
Professor of Neurology, Xuanwu Hospital, Capital Medical University
Capital Medical University
研究点 (54)
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