RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Capital Medical University • ClinicalTrials.gov ID: NCT07509645

Registry updated: 2026-10-13

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Description

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.

Interventions

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.
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.

Eligibility criteria

Inclusion Criteria: 1. Age 18 years or older, of either sex; 2. Acute ischemic stroke caused by occlusion of the basilar artery; 3. Decide to undergo emergency endovascular treatment; 4. Time from stroke onset to groin puncture within 24 hours; 5. National Institutes of Health Stroke Scale (NIHSS) ≥ 10; 6. Posterior circulation Alberta Stroke Program Early computed tomography score (pc-ASPECTS) ≥ 6; 7. 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 ≥180 mmHg or diastolic blood pressure ≥110 mmHg despite blood pressure control; 8. Neutrophils \< 2 × 10\^9 /L; 9. Platelets \< 100 × 10\^9 /L; 10. Blood glucose \<2.8 mmol/L (50 mg/dL) or \>22.2 mmol/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. Any circumstance that, as assessed by the investigators, might result in harm to the patients if study therapy is initiated; 20. Other conditions that the investigator considers might affect compliance or preclude participation in this study.

Conditions

Ischemic Stroke

Locations

Suixi County Hospital — Huaibei, Anhui, China
Suzhou Municipal Hospital — Suzhou, Anhui, China
Heyuan People's Hospital — Heyuan, Guangdong, China
Huazhou People's Hospital — Maoming, Guangdong, China
Qinhuangdao Second People's Hospital — Qinhuangdao, Hebei, China
Tangshan Gongren Hospital — Tangshan, Hebei, China
Yutian County Hospital — Tangshan, Hebei, China
Anyang People's Hospital — Anyang, Henan, China
Junxian People's Hospital — Hebi, Henan, China
Luoyang Central Hospital — Luoyang, Henan, China
Nanyang Central Hospital — Nanyang, Henan, China
Puyang Oiled General Hospital — Puyang, Henan, China
Shangqiu First People's Hospital — Shangqiu, Henan, China
Ningling County Hospital — Shangqiu, Henan, China
The First Affiliated Hospital of Henan Medical University — Xinxiang, Henan, China
Shenqiu County Hospital — Zhoukou, Henan, China
People's Hospital of Xihua — Zhoukou, Henan, China
Xiangyang First People's Hospital — Xiangyang, Hubei, China
Liuyang Jili Hospital — Guankou, Hunan, China
Yancheng First People's Hospital — Yancheng, Jiangsu, China
People's Hospital of Linyi — Linyi, Shandong, China
Zibo Central Hospital — Zibo, Shandong, China
Xianyang First People's Hospital — Xianyang, Shanxi, China
Yuncheng Central Hospital — Yuncheng, Shanxi, China
Jiaxing First People's Hospital — Jiaxing, Zhejiang, China
Lishui Central Hospital — Lishui, Zhejiang, China
Taizhou enze Hospital — Taizhou, Zhejiang, China
Wenzhou People's Hospital — Wenzhou, Zhejiang, China
People's Hospital of Yueqing — Yueqing, Zhejiang, China
Capital Medical Univercity Xuanwu Hospital — Beijing, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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