Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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.


