RecruitingPhase 3NCT07509645

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

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

Sponsor

Capital Medical University

Enrollment

348 participants

Start Date

Apr 20, 2026

Study Type

INTERVENTIONAL

Conditions

Ischemic Stroke

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

Min Age: 18 Years

Inclusion Criteria7

Age 18 years or older, of either sex;
Acute ischemic stroke caused by occlusion of the basilar artery;
Decide to undergo emergency endovascular treatment;
Time from stroke onset to groin puncture within 24 hours;
National Institutes of Health Stroke Scale (NIHSS) ≥ 10;
Posterior circulation Alberta Stroke Program Early computed tomography score (pc-ASPECTS) ≥ 6;
Signed informed consent from the patients or the legally authorized representatives.

Exclusion Criteria20

Intracerebral hemorrhage, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage;
Pre-stroke modified Rankin scale (mRS) score >1;
Known allergy to tocilizumab or excipients;
Known allergy to iodinated contrast agents;
Anticipated difficulty in completing endovascular treatment due to vascular tortuosity;
History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, or thrombocytopenic diseases;
Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg despite blood pressure control;
Neutrophils < 2 × 10\^9 /L;
Platelets < 100 × 10\^9 /L;
Blood glucose <2.8 mmol/L (50 mg/dL) or >22.2 mmol/L (400 mg/dL);
Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >2 times the upper limit of normal;
Known recent or current serum creatinine >2 times the upper limit of normal or estimated glomerular filtration rate (eGFR) <60 mL/min;
Pregnant, lactating, or planning pregnancy within 90 days;
Severe mental disorders or inability to comply with informed consent and follow-up requirements due to dementia;
Concurrent malignant tumors or severe systemic diseases with expected survival of less than 90 days;
Presence of autoimmune diseases or use of immunosuppressive drugs;
Systemic infectious diseases;
Participation in another interventional clinical study within 30 days before randomization or currently participating in another interventional clinical study;
Any circumstance that, as assessed by the investigators, might result in harm to the patients if study therapy is initiated;
Other conditions that the investigator considers might affect compliance or preclude participation in this study.

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Interventions

DRUGTocilizumab

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.

DRUGPlacebo

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.