Tocilizumab with endovascular therapy for acute basilar artery large-vessel occlusion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled phase III trial enrolls adults with acute basilar artery large-vessel occlusion who are planned for endovascular therapy within 24 hours. Participants are randomized to receive either tocilizumab or placebo in addition to standard endovascular treatment, with both investigators and patients blinded to allocation. Key inclusion criteria include NIHSS ≥10 and pc-ASPECTS ≥6, while major exclusions include intracranial hemorrhage, pre-stroke disability (mRS >1), known allergies to study agents or contrast, and bleeding disorders. The trial compares clinical outcomes and safety between arms to see if IL-6 blockade improves prognosis after posterior circulation stroke.

Why it matters

Who can join: the full rules

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.

Where it's running

• Suixi County Hospital
  Huaibei, Anhui, China Recruiting
• Suzhou Municipal Hospital
  Suzhou, Anhui, China Recruiting
• Heyuan People's Hospital
  Heyuan, Guangdong, China Recruiting
• Huazhou People's Hospital
  Maoming, Guangdong, China Recruiting
• Qinhuangdao Second People's Hospital
  Qinhuangdao, Hebei, China Recruiting
• Tangshan Gongren Hospital
  Tangshan, Hebei, China Recruiting

Study contacts

• Study coordinator: Xunming Ji
• Email: jixm@ccmu.edu.cn
• Phone: 01083198962

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.