Effect of Interleukin-6 Receptor Inhibition in Patients With Ischemic Stroke Undergoing Endovascular Treatment: a Double-blind, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change from baseline in infarct-core volume
研究概览
简要总结
Tocilizumab may exert neuroprotective effects in patients with ischemic stroke undergoing endovascular treatment
详细描述
Vascular recanalization techniques, including thrombolysis and thrombectomy, have become the mainstay of treatment for acute ischemic stroke. However, some patients still experience poor prognosis, with ineffective recanalization and reperfusion brain injury being the major contributors to unfavorable outcomes. Studies have indicated that tocilizumab, used in ST-segment elevation and non-ST-segment elevation myocardial infarction, exhibits anti-inflammatory and myocardial protective effects. Nevertheless, whether tocilizumab can provide neuroprotection in the early stages of acute large vessel recanalization remains uncertain. Given the above evidence, the aim of this study was to investigate whether combination therapy with tocilizumab in the early phase of recanalization of acute large vessel occlusion could further exert a beneficial effect and thus improve the poor prognosis of patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Hemorrhagic diseases visible on head CT: hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.
- •Pre-stroke mRS score >
- •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, thrombocytopenic diseases, etc.
- •Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg despite blood pressure control.
- •Neutrophil < 2×10 9/L.
- •Platelet < 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 greater than 1.5 times the upper limit of normal.
- •Known recent or current serum creatinine exceeding 1.5 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 an 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.
研究组 & 干预措施
Tocilizumab group
Intravenously for more than 1 hour.
干预措施: Tocilizumab (Drug)
Control group
Intravenously for more than 1 hour.
干预措施: NaCl 0.9% 100ml (Drug)
结局指标
主要结局
Change from baseline in infarct-core volume
时间窗: 72 hours
The infarct-core volume is determined by diffusion-weighted MRI, CT, or CTP images.
次要结局
- Death(90 days)
- Early neurological improvement(within 24 hours)
- Proportion of recanalization on follow-up CTA or MRA(72 hours)
- Proportion of patients with functional independence (mRS 0-2)(90 days)
- NIHSS score(7 days)
- Incidence of cerebral hemorrhage(72 hours)
- Adverse events and serious adverse events(90 days)
- Incidence of symptomatic cerebral hemorrhage(72 hours)
- Barthel Index(90 days)
- EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D)(90 days)
- Proportion of successful reperfusion (mTICI 2b/3)(immediate postoperative)
- Incidence of stroke-associated pneumonia(7 days)
- Incidence of decompressive craniectomy(7 days)
- Shift analysis of mRS score(90 days)