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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab | Experimental | Endovascular treatment combined with a 240mg tocilizumab injection once |
|
| Placebo | Placebo Comparator | Endovascular treatment combined with placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | 240 mg of tocilizumab injection will be diluted in 0.9% NaCl to a total 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 |
|---|---|---|
| Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 days. | The mRS ranges from 0 to 6, with higher scores indicating worse outcomes. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| mRS score distribution at 90 days; | The mRS ranges from 0 to 6, with higher scores indicating worse outcomes. | 90 days |
| Early neurological improvement at 24 hours | Defined as a reduction in NIHSS score of at least 8 points from baseline or a score of 0 to 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptomatic intracranial hemorrhage within 24 hours | 24 hours | |
| Incidence of any intracranial hemorrhage within 24 hours | 24 hours | |
| Proportion of patients with pneumonia at 7 days or at early discharge |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xunming Ji | Contact | 01083198962 | jixm@ccmu.edu.cn | |
| Chuanjie Wu | Contact | 01083199439 | wuchuanjie@ccmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suzhou Municipal Hospital | Recruiting | Suzhou | Anhui | 234000 | China |
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 to a total 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. |
|
| 24 hours |
| NIHSS score at 7 days or at early discharge | The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes | 7 days |
| Proportion of patients with mRS score 0-1 at 90 days | The mRS ranges from 0 to 6, with higher scores indicating worse outcomes. | 90 days |
| Proportion of patients with mRS score 0-2 at 90 days | The mRS ranges from 0 to 6, with higher scores indicating worse outcomes. | 90 days |
| Proportion of patients with mRS score 0-4 at 90 days | The mRS ranges from 0 to 6, with higher scores indicating worse outcomes. | 90 days |
| EQ-5D-5L at 90 days | The EQ-5D-5L comprises the same five dimensions: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION, each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. | 90 days |
| Proportion of Barthel Index (BI) 95-100 at 90 days | 90 days |
| 7 days |
| Mortality at 90 days | 90 days |
| Anyang People's Hospital | Recruiting | Anyang | Henan | 455000 | China |
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| Nanyang Central Hospital | Recruiting | Nanyang | Henan | 473000 | China |
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| The First Affiliated Hospital of Henan Medical University | Recruiting | Xinxiang | Henan | 453000 | China |
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| People's Hospital of Xihua | Recruiting | Zhoukou | Henan | 466600 | China |
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| People's Hospital of Linyi | Recruiting | Linyi | Shandong | 276000 | China |
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| Zibo Central Hospital | Recruiting | Zibo | Shandong | 255000 | China |
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| Xianyang First People's Hospital | Recruiting | Xianyang | Shanxi | 712000 | China |
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| Yuncheng Central Hospital | Recruiting | Yuncheng | Shanxi | 044000 | China |
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| Lishui Central Hospital | Recruiting | Lishui | Zhejiang | 323000 | China |
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| Taizhou enze Hospital | Recruiting | Taizhou | Zhejiang | 318000 | China |
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| People's Hospital of Yueqing | Recruiting | Yueqing | Zhejiang | 325600 | China |
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| Capital Medical Univercity Xuanwu Hospital | Recruiting | Beijing | 100053 | China |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| 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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