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Clinical Trials in China / NCT07509645
Recruiting Phase 3

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

NCT07509645 · tracked via the Priya Life Science China tracker
Sponsor
Capital Medical University
Phase
Phase 3
Started
2026-04-22
Last updated
2026-09-09

Condition(s) studied

Ischemic Stroke

Investigational drug(s) / intervention(s)

Tocilizumab →Placebo

Tocilizumab: 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: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
Suzhou Municipal Hospital Suzhou Anhui Recruiting
Anyang People's Hospital Anyang Henan Recruiting
Nanyang Central Hospital Nanyang Henan Recruiting
The First Affiliated Hospital of Henan Medical University Xinxiang Henan Recruiting
People's Hospital of Xihua Zhoukou Henan Recruiting
People's Hospital of Linyi Linyi Shandong Recruiting
Zibo Central Hospital Zibo Shandong Recruiting
Xianyang First People's Hospital Xianyang Shanxi Recruiting
Yuncheng Central Hospital Yuncheng Shanxi Recruiting
Lishui Central Hospital Lishui Zhejiang Recruiting
Taizhou enze Hospital Taizhou Zhejiang Recruiting
People's Hospital of Yueqing Yueqing Zhejiang Recruiting
Capital Medical Univercity Xuanwu Hospital Beijing China Recruiting

On this site

📄 Actemra (tocilizumab) drug profile →

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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 NCT07509645 on ClinicalTrials.gov ↗ ← All trials in China