NCT07509645招募中3 期
Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Posterior Circulation Large Vessel Occlusion Stroke: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial-3
Capital Medical University13 个研究点 分布在 1 个国家目标入组 348 人开始时间: 2026年4月22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
- 招募中
- 发起方
- 入组人数
- 348
- 试验地点
- 13
- 主要终点
- Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 days.
研究概览
简要总结
This is an investigator-initiated phase III clinical trial employing a randomized, double-blind, placebo-controlled design. The primary objective of this study is to investigate the efficacy and safety of an interleukin-6 inhibitor (tocilizumab) combined with endovascular therapy in patients with acute posterior circulation large-vessel occlusion stroke.
详细描述
This is an investigator-initiated, prospective, multicenter phase III clinical trial. This trial aims to investigate whether tocilizumab could further improve prognosis for patients with acute posterior circulation large-vessel occlusion stroke receiving endovascular therapy.
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 older, of either sex;
- •Acute ischemic stroke caused by occlusion of the basilar artery;
- •Decide to undergo emergency endovascular treatment;
- •Time from stroke onset to groin puncture within 24 hours;
- •National Institutes of Health Stroke Scale (NIHSS) ≥ 10;
- •Posterior circulation Alberta Stroke Program Early computed tomography score (pc-ASPECTS) ≥ 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 ≥180 mmHg or diastolic blood pressure ≥110 mmHg despite blood pressure control;
- •Neutrophils < 2 × 10^9 /L;
- •Platelets < 100 × 10^9 /L;
- •Blood glucose <2.8 mmol/L (50 mg/dL) or >22.2 mmol/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;
- •Any circumstance that, as assessed by the investigators, might result in harm to the patients if study therapy is initiated;
- •Other conditions that the investigator considers might affect compliance or preclude participation in this study.
研究组 & 干预措施
Placebo
Placebo Comparator
Endovascular treatment combined with placebo
干预措施: Placebo (Drug)
Tocilizumab
Experimental
Endovascular treatment combined with a 240mg tocilizumab injection once
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 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
- mRS score distribution at 90 days;(90 days)
- Early neurological improvement at 24 hours(24 hours)
- NIHSS score at 7 days or at early discharge(7 days)
- Proportion of patients with mRS score 0-1 at 90 days(90 days)
- Proportion of patients with mRS score 0-2 at 90 days(90 days)
- Proportion of patients with mRS score 0-4 at 90 days(90 days)
- EQ-5D-5L at 90 days(90 days)
- Proportion of Barthel Index (BI) 95-100 at 90 days(90 days)
- mRS score distribution(90 days and 1 year)
- Proportion of patients with mRS score 0-1(90 days and 1 year)
- Proportion of patients with mRS score 0-2(90 days and 1 year)
- Proportion of patients with mRS score 0-4(90 days and 1 year)
- EQ-5D-5L(90 days and 1 year)
- Proportion of Barthel Index (BI) 95-100(90 days and 1 year)
研究者
Ji Xunming,MD,PhD
Professor of Neurology, Capital Medical University Xuanwu Hospital
Capital Medical University
研究点 (13)
Loading locations...
相似试验
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 -2NCT07263776Capital Medical University692
招募中
2 期
Neutralizing Interleukin (IL)-6Major Depressive DisorderNCT07493317Icahn School of Medicine at Mount Sinai60
已完成
1 期
Dose Escalation Study Assessing the Safety and Immune Response of PPV-06 VaccineKnee OsteoarthritisNCT04447898Peptinov SAS24
尚未招募
2 期
Phase 2 Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Platinum Chemotherapy Versus Platinum Chemotherapy in the Treatment of Second-/Third-line Triple Negative Breast Cancer (TNBC)NCT07413601Cancer Institute and Hospital, Chinese Academy of Medical Sciences78
已完成
不适用
Interleukin-6 in the Development of Meconium Aspiration Syndrome in NewbornMeconium Aspiration SyndromeNCT07394322Benha University120