Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Anterior Circulation Large Vessel Occlusion Stroke -2
NCT ID: NCT07263776
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
692 participants
INTERVENTIONAL
2025-12-05
2027-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tocilizumab group
Endovascular treatment combined 240 mg tocilizumab injection once.
Tocilizumab
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.
Placebo group
Endovascular treatment combined equivalent volume of placebo once.
Placebo
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.
Interventions
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Tocilizumab
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.
Placebo
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.
Eligibility Criteria
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Inclusion Criteria
2. Acute ischemic stroke caused by occlusion of intracranial segment of the internal carotid artery, middle cerebral artery M1 or proximal/dominant M2 segment;
3. Decided to undergo emergency endovascular treatment;
4. Time from stroke onset to arterial puncture within 24 hours;
5. National Institutes of Health Stroke Scale (NIHSS) score ≥ 6;
6. Signed informed consent from the patients or the legally authorized representatives.
Exclusion Criteria
2. Pre-stroke modified Rankin scale (mRS) score \>1;
3. Known allergy to tocilizumab or excipients;
4. Known allergy to iodinated contrast agents;
5. Anticipated difficulty in completing endovascular treatment due to vascular tortuosity;
6. History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, or thrombocytopenic diseases;
7. Systolic blood pressure ≥180mmHg or diastolic blood pressure ≥110mmHg despite blood pressure control;
8. Neutrophils \<2×109 /L;
9. Platelets \<100×109 /L;
10. Blood glucose \<2.8mmol/L (50 mg/dL) or \>22.2mmol/L (400 mg/dL);
11. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \>2 times the upper limit of normal;
12. Known recent or current serum creatinine \>2 times the upper limit of normal or estimated glomerular filtration rate (eGFR) \<60 mL/min;
13. Pregnant, lactating, or planning pregnancy within 90 days;
14. Severe mental disorders or inability to comply with informed consent and follow-up requirements due to dementia;
15. Concurrent malignant tumors or severe systemic diseases with expected survival of less than 90 days;
16. Presence of autoimmune diseases or use of immunosuppressive drugs;
17. Systemic infectious diseases;
18. Participation in another interventional clinical study within 30 days before randomization or currently participating in another interventional clinical study;
19. Considered by the investigator to have other conditions that might affect compliance or preclude participation in this study.
18 Years
ALL
No
Sponsors
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Capital Medical University
OTHER
Responsible Party
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Ji Xunming,MD,PhD
Professor of Neurology, Xuanwu Hospital, Capital Medical University
Locations
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Si Country People's Hospital
Suzhou, Anhui, China
Lingshan County People's Hospital
Qinzhou, Guangxi, China
The second Hospital of Qinhuangdao
Qinhuangdao, 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
Henan Provincial People's Hospital
Zhengzhou, 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
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
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
Xuanwu Hospital, Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Lei Shi
Role: primary
Xingcheng Lin
Role: primary
Guanglei Li
Role: primary
Haijun Li
Role: primary
Shancai Xu
Role: primary
Jiangang Zhang
Role: primary
Beibei Jiang
Role: primary
Liangfu Zhu
Role: primary
Xing Wang
Role: primary
Xiaolong Li
Role: primary
Fangrui Li
Role: primary
Yuliang Wang
Role: primary
Xiaoming Zhou
Role: primary
Shoujun Ma
Role: primary
Hao Wang
Role: primary
Chengjun Li
Role: primary
Xiaofeng Tang
Role: primary
Tiandong Wang
Role: primary
Xingyun Yuan
Role: primary
Guoyu Wang
Role: primary
Hua Yang
Role: primary
Other Identifiers
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IRIS-2
Identifier Type: -
Identifier Source: org_study_id
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