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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
692
240 mg of tocilizumab injection will be diluted in 0.9% NaCl solution to prepare a total solution volume of 100 mL. The solution will be administered via intravenous infusion immediately after randomization, and no later than 30 minutes, with an infusion duration of more than 1 hour.
An equivalent volume of placebo will be diluted in 0.9% NaCl solution to prepare a total solution volume of 100 mL. The solution will be administered via intravenous infusion immediately after randomization, and no later than 30 minutes, with an infusion duration of more than 1 hour.
modified Rankin Scale (mRS) score at 90 days
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
Time frame: 90 days
Proportion of patients with mRS score 0-2 at 90 days
Time frame: 90 days
Proportion of patients with mRS score 0-1 at 90 days
Time frame: 90 days
National Institutes of Health Stroke Scale (NIHSS) score at 7 days or at early discharge
The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes.
Time frame: 7 days or at early discharge
Infarct volume at 24 hours
Time frame: 24 hours
EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) at 90 days
The EQ-5D-5L includes 5 dimensions: mobility, self-care, usual activities,pain/discomfort, and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scoresindicating worse quality of life.
Time frame: 90 days
Proportion of Barthel Index (BI) 95-100 at 90 days
Time frame: 90 days
Incidence of symptomatic intracerebral hemorrhage within 24 hours
Time frame: 24 hours
Incidence of any intracerebral hemorrhage within 24 hours
Time frame: 24 hours
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Si Country People's Hospital
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Suzhou Hospital of Anhui Medical University
Suzhou, Anhui, China
Zhangzhou Municipal Hospital
Zhangzhou, Fujian, China
Lingshan County People's Hospital
Qinzhou, Guangxi, China
JingDong ZhongMei Hospital
Langfang, Hebei, China
The second Hospital of Qinhuangdao
Qinhuangdao, Hebei, China
Tangshan Workers Hospital
Tangshan, Hebei, China
Yutian Hospital
Tangshan, Hebei, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
...and 44 more locations
Proportion of patients with pneumonia at 7 days or at early discharge
Time frame: 7 days or at early discharge
Mortality at 90 days
Time frame: 90 days