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NOT YET RECRUITING

NCT07509645

PHASE3

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

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Posterior Circulation Large Vessel Occlusion Stroke: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial-3

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

348

Start Date

2026-04-10

Completion Date

2027-04-10

Last Updated

2026-04-03

Healthy Volunteers

Conditions

Ischemic Stroke

Interventions

DRUG

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.

DRUG

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.

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.

Locations (1)

Capital Medical Univercity Xuanwu Hospital

Beijing, China