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

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.

This is an investigator-initiated, prospective, multicenter phase III clinical trial. This trial aims to investigate whether tocilizumab could further improve prognosis for patients with acute posterior circulation large-vessel occlusion stroke receiving endovascular therapy.

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.