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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT07509645

Run by

Capital Medical University

People needed

348

Starts

2026-04-22

Expected to finish

2027-04-20

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Suzhou Municipal Hospital — Suzhou, Anhui, China (enrolling)
• Anyang People's Hospital — Anyang, Henan, China (enrolling)
• Nanyang Central Hospital — Nanyang, Henan, China (enrolling)
• The First Affiliated Hospital of Henan Medical University — Xinxiang, Henan, China (enrolling)
• People's Hospital of Xihua — Zhoukou, Henan, China (enrolling)
• People's Hospital of Linyi — Linyi, Shandong, China (enrolling)
• Zibo Central Hospital — Zibo, Shandong, China (enrolling)
• Xianyang First People's Hospital — Xianyang, Shanxi, China (enrolling)
• Yuncheng Central Hospital — Yuncheng, Shanxi, China (enrolling)
• Lishui Central Hospital — Lishui, Zhejiang, China (enrolling)
• Taizhou enze Hospital — Taizhou, Zhejiang, China (enrolling)
• People's Hospital of Yueqing — Yueqing, Zhejiang, China (enrolling)
• Capital Medical Univercity Xuanwu Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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