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

Official title

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

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.

Detailed 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.

Interventions

• Drug Tocilizumab
  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.
• Drug Placebo
  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.

Primary outcome measures

• Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 days. [Time frame: 90 days]

Secondary outcome measures (8)

• mRS score distribution at 90 days; [Time frame: 90 days]
• Early neurological improvement at 24 hours [Time frame: 24 hours]
• NIHSS score at 7 days or at early discharge [Time frame: 7 days]
• Proportion of patients with mRS score 0-1 at 90 days [Time frame: 90 days]
• Proportion of patients with mRS score 0-2 at 90 days [Time frame: 90 days]
• Proportion of patients with mRS score 0-4 at 90 days [Time frame: 90 days]
• EQ-5D-5L at 90 days [Time frame: 90 days]
• Proportion of Barthel Index (BI) 95-100 at 90 days [Time frame: 90 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 13 centers

• Suzhou Municipal Hospital — Suzhou
• Anyang People's Hospital — Anyang
• Nanyang Central Hospital — Nanyang
• The First Affiliated Hospital of Henan Medical University — Xinxiang
• People's Hospital of Xihua — Zhoukou
• People's Hospital of Linyi — Linyi
• Zibo Central Hospital — Zibo
• Xianyang First People's Hospital — Xianyang
• … and 5 more centers

Identifiers

NCT: NCT07509645 · IRIS-3

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗