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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab group | Experimental | Endovascular treatment combined 240 mg tocilizumab injection once. |
|
| Placebo group | Placebo Comparator | Endovascular treatment combined equivalent volume of placebo once. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| modified Rankin Scale (mRS) score at 90 days | The mRS ranges from 0 to 6, with higher scores indicating worse outcomes. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with mRS score 0-2 at 90 days | 90 days | |
| Proportion of patients with mRS score 0-1 at 90 days | 90 days | |
| National Institutes of Health Stroke Scale (NIHSS) score at 7 days or at early discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Si Country People's Hospital | Suzhou | Anhui | China | |||
| Suixi County Hospital |
Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
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|
| Placebo | Drug | 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. |
|
The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes. |
| 7 days or at early discharge |
| Infarct volume at 24 hours | 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. | 90 days |
| Proportion of Barthel Index (BI) 95-100 at 90 days | 90 days |
| 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 |
| Mortality at 90 days | 90 days |
| Suzhou |
| Anhui |
| China |
| 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 |
| The People's Hospital of Anyang | Anyang | Henan | China |
| Jun County People's Hospital | Hebi | Henan | China |
| Jiaozuo No.2 People's Hospital | Jiaozuo | Henan | China |
| Luoyang Central Hospital | Luoyang | Henan | China |
| Mengjin County People's Hospital | Luoyang | Henan | China |
| Nanyang Central Hospital | Nanyang | Henan | China |
| Nanyang Nanshi Hospital | Nanyang | Henan | China |
| Nanyang Second People's Hospital | Nanyang | Henan | China |
| Tanghe County People's Hospital | Nanyang | Henan | China |
| Puyang Oilfield General Hospital | Puyang | Henan | China |
| Ningling County People's Hospital | Shangqiu | Henan | China |
| Shangqiu No.1 People's Hospital | Shangqiu | Henan | China |
| Huixian People's Hospital | Xinxiang | Henan | China |
| The First Affiliated Hospital of Henan Medical University | Xinxiang | Henan | China |
| Xinxiang Central Hospital | Xinxiang | Henan | China |
| Henan Provincial People's Hospital | Zhengzhou | Henan | China |
| Xihua County People's Hospital | Zhoukou | Henan | China |
| Tianyou Hospital Affliated to Wuhan University of Science &Technology | Wuhan | Hubei | China |
| Xiangyang No.1 People's hospital | Xiangyang | Hubei | China |
| Xing'an league People's Hospital | Xing’an | Inner Mongolia | China |
| Nantong First People's Hospital | Nantong | Jiangsu | China |
| Binzhou Medical University Hospital | Binzhou | Shandong | China |
| People's Hospital of Dongying | Dongying | Shandong | China |
| Linshu Country People's Hospital | Linyi | Shandong | China |
| Linyi People's Hospital | Linyi | Shandong | China |
| Qingdao Huangdao District Hospital of Traditional Chinese Medicine | Qingdao | Shandong | China |
| Yiyuan Country People's Hospital | Zibo | Shandong | China |
| Zibo Central Hospital | Zibo | Shandong | China |
| Jincheng People's Hospital | Jincheng | Shanxi | China |
| Shanxi Bethune Hospital | Taiyuan | Shanxi | China |
| Shanxi Medical University First Hospital | Taiyuan | Shanxi | China |
| The People's Hospital of Xianyang | Xianyang | Shanxi | China |
| Daliuta Experimental District People's Hospital of Shenmu City | Yulin | Shanxi | China |
| Zhongxiang Traditional Chinese Medical Hospital | Zhongxiang | Wuhan | China |
| Jiaxing First Hospital | Jiaxing | Zhejiang | China |
| Lishui Central Hospital | Lishui | Zhejiang | China |
| Ningbo Medical Center Lihuili Hospital | Ningbo | Zhejiang | China |
| Ningbo NO.2 Hospital | Ningbo | Zhejiang | China |
| Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University | Taizhou | Zhejiang | China |
| Wenzhou People's Hospital | Wenzhou | Zhejiang | China |
| Yueqing People's Hospital | Yueqing | Zhejiang | China |
| Xuanwu Hospital, Capital Medical University | Beijing | 100053 | China |
| Beijing Red Cross Emergency Medical Center | Beijing | China |
| Shenzhen Longhua District People's Hospital | Shenzhen | China |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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