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Clinical Trials in China / NCT07263776
Active, not recruiting Phase 3

Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Anterior Circulation Large Vessel Occlusion Stroke -2

NCT07263776 · tracked via the Priya Life Science China tracker
Sponsor
Capital Medical University
Phase
Phase 3
Started
2025-12-05
Last updated
2026-09-21

Condition(s) studied

Acute Ischemic Stroke

Investigational drug(s) / intervention(s)

Tocilizumab →Placebo

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age 18 years or greater, male or female; 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: 1. Intracerebral hemorrhage, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage; 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.

Primary outcome measure(s)

Trial sites (54)

FacilityCityRegionStatus
Si Country People's Hospital Suzhou Anhui
Suixi County Hospital Suzhou Anhui
Suzhou Hospital of Anhui Medical University Suzhou Anhui
Zhangzhou Municipal Hospital Zhangzhou Fujian
Lingshan County People's Hospital Qinzhou Guangxi
JingDong ZhongMei Hospital Langfang Hebei
The second Hospital of Qinhuangdao Qinhuangdao Hebei
Tangshan Workers Hospital Tangshan Hebei
Yutian Hospital Tangshan Hebei
The First Affiliated Hospital of Harbin Medical University Harbin Heilongjiang
The People's Hospital of Anyang Anyang Henan
Jun County People's Hospital Hebi Henan
Jiaozuo No.2 People's Hospital Jiaozuo Henan
Luoyang Central Hospital Luoyang Henan
Mengjin County People's Hospital Luoyang Henan
Nanyang Central Hospital Nanyang Henan
Nanyang Nanshi Hospital Nanyang Henan
Nanyang Second People's Hospital Nanyang Henan
Tanghe County People's Hospital Nanyang Henan
Puyang Oilfield General Hospital Puyang Henan
Ningling County People's Hospital Shangqiu Henan
Shangqiu No.1 People's Hospital Shangqiu Henan
Huixian People's Hospital Xinxiang Henan
The First Affiliated Hospital of Henan Medical University Xinxiang Henan
Xinxiang Central Hospital Xinxiang Henan
Henan Provincial People's Hospital Zhengzhou Henan
Xihua County People's Hospital Zhoukou Henan
Tianyou Hospital Affliated to Wuhan University of Science &Technology Wuhan Hubei
Xiangyang No.1 People's hospital Xiangyang Hubei
Xing'an league People's Hospital Xing’an Inner Mongolia
Nantong First People's Hospital Nantong Jiangsu
Binzhou Medical University Hospital Binzhou Shandong
People's Hospital of Dongying Dongying Shandong
Linshu Country People's Hospital Linyi Shandong
Linyi People's Hospital Linyi Shandong
Qingdao Huangdao District Hospital of Traditional Chinese Medicine Qingdao Shandong
Yiyuan Country People's Hospital Zibo Shandong
Zibo Central Hospital Zibo Shandong
Jincheng People's Hospital Jincheng Shanxi
Shanxi Bethune Hospital Taiyuan Shanxi

+ 14 more sites — see the full list on the official registry below.

On this site

📄 Actemra (tocilizumab) drug profile →

More Capital Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07263776 on ClinicalTrials.gov ↗ ← All trials in China