Methylprednisolone for Stroke With Large Infarct Core and Post-stroke Lymphocytopenia

Официальное название

Methylprednisolone as Adjunct to Endovascular Thrombectomy for Acute Ischemic Stroke With Large Infarct Core and Post-stroke Lymphocytopenia -A Multicenter, Randomized, Double-blind, Placebo-controlled, Non-inferiority Trial

Обзор

The efficacy and safety of early adjunctive methylprednisolone therapy in acute ischemic stroke patients with large infarct cores (ASPECTS score \< 6) and post-stroke lymphocytopenia remain unclear. These immunocompromised patients face higher mortality rates and poorer clinical outcomes, with limited effective treatment options currently available. This multicenter, randomized, double-blind, placebo-controlled, non-inferiority trial aims to demonstrate that early methylprednisolone administration combined with reperfusion therapy is non-inferior to placebo in terms of survival and functional outcomes at 90 days.

Вмешательства

• Препарат Methylprednisolone sodium succinate
  Methylprednisolone sodium succinate Intravenous injection of methylprednisolone sodium succinate (Chongqing Lummy Pharmaceutical Co., Ltd., 40mg/ vial) with a dose of 2mg/kg (maximum dose of 160mg), once daily, for three consecutive days. The initial study drug will be administered as soon as possible after randomization. It is recommended that the initial study drug administrated before arterial access closure, but it should not be delayed more than 2 hours after arterial access closure.
• Препарат Normal Saline
  Intravenous injection of placebo (normal saline) (Chongqing Lummy Pharmaceutical Co., Ltd., 40mg/ bottle) with a dose of 2mg/kg (maximum dose of 160mg), once daily, for three consecutive days. The initial study drug will be administered as soon as possible after randomization. It is recommended that the initial study drug administrated before arterial access closure, but it should not be delayed more than 2 hours after arterial access closure.

Первичные конечные точки

• All-cause mortality at 90 (±7) days [Срок оценки: From randomization to 90 (±7) days]

Вторичные конечные точки (12)

• Time from randomization to the occurrence of death from any cause at 90 (±7) days [Срок оценки: From randomization to 90 (±7) days]
• mRS ordinal shift at 90 (±7) days (scores 5 and 6 are merged) [Срок оценки: From randomization to 90 (±7) days]
• Proportion of patients with mRS score 0 to 4 at 90 (±7) days [Срок оценки: From randomization to 90 (±7) days]
• Proportion of patients with mRS score 0 to 3 at 90 (±7) days [Срок оценки: From randomization to 90 (±7) days]
• Proportion of patients with mRS score 0 to 2 at 90 (±7) days [Срок оценки: From randomization to 90 (±7) days]
• Proportion of patients with mRS score 0 to 1 at 90 (±7) days or return to pre-stroke mRS score (for patients with prestroke mRS > 1) [Срок оценки: From randomization to 90 (±7) days]
• Midline shift at 48 hours [Срок оценки: From randomization to 48 hours]
• Proportion of patients with midline shift maximum > 5 mm within 48 hours (%) [Срок оценки: From randomization to 48 hours]
• Relative hemispheric volume at 48 hours [Срок оценки: From randomization to 48 hours]
• Net water uptake at 48 hours [Срок оценки: From randomization to 48 hours]
• Proportion of patients with decompressive craniectomy after EVT [Срок оценки: From randomization until the date of discharge, an average of 1 week]
• NIHSS score at 5-7 days or at early discharge [Срок оценки: From randomization to 5-7 days (or at early discharge)]

Критерии участия

Критерии включения

• Age ≥ 18 years.
• The time from last known well to randomization was within 24 hours.
• Anterior circulation ischemic stroke was preliminarily determined according to clinical symptoms or imaging examination.
• Occlusion of the intracranial internal carotid artery, the M1- or M2-segment of the middle cerebral artery by confirmed by CT angiography (CTA), MR angiography (MRA), or digital subtraction angiography (DSA).
• Baseline National Institutes of Health Stroke Scale (NIHSS) ≥ 6.
• Baseline Alberta Stroke Program Early CT Score (ASPECTS) < 6 (based on non-contrast CT or MRI) or core infarct volume ≥ 50 ml (based on CTP with rCBF < 30%).
• Planned treatment with endovascular thrombectomy (EVT).
• Baseline peripheral blood lymphocyte < 0.8×10#/L
• Informed consent obtained from patients or their legal representatives.

Критерии исключения

• Intracranial hemorrhage confirmed by cranial CT or MRI.
• mRS score > 2 before the time of last known well.
• Pregnant or lactating women.
• Allergic to contrast agents or glucocorticoids.
• Participating in other clinical trials.
• The artery is tortuous so that the thrombectomy device cannot reach the target vessel.
• Bleeding history (gastrointestinal and urinary tract bleeding) in recent 1 month.
• Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate < 30 ml/min or serum creatinine > 220 umol/L \[2.5 mg/ dL\]).
• Life expectancy due to any advanced disease < 6 months.
• Follow-up is not expected to be completed.
• Intracranial aneurysm and arteriovenous malformation.
• Brain tumors with imaging mass effect.
• Systemic infectious disease.

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 · 1 центр

• Department of Neurology, the First Affiliated Hospital Fujian Medical University — Фучжоу

Идентификаторы

NCT: NCT07202143 · MRCTA, ECFAH of FMU [2025]887

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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