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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

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

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 13 центров

• Suzhou Municipal Hospital — Сучжоу
• 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
• … и ещё 5 центров

Идентификаторы

NCT: NCT07509645 · IRIS-3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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