NCT07202143招募中3 期
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
YiLin1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年9月1日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- All-cause mortality at 90 (±7) days
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) ≥
- •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.
排除标准
- •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.
研究组 & 干预措施
Methylprednisolone sodium succinate group
Experimental
干预措施: Methylprednisolone sodium succinate (Drug)
Methylprednisolone sodium succinate simulant (normal saline placebo)
Placebo Comparator
干预措施: Normal Saline (Drug)
结局指标
主要结局
All-cause mortality at 90 (±7) days
时间窗: From randomization to 90 (±7) days
Primary Efficacy Outcome. Defined as the number of any cause deaths observed divided by the number of subjects observed over the 90-day study period.
次要结局
- Time from randomization to the occurrence of death from any cause at 90 (±7) days(From randomization to 90 (±7) days)
- mRS ordinal shift at 90 (±7) days (scores 5 and 6 are merged)(From randomization to 90 (±7) days)
- Proportion of patients with mRS score 0 to 4 at 90 (±7) days(From randomization to 90 (±7) days)
- Proportion of patients with mRS score 0 to 3 at 90 (±7) days(From randomization to 90 (±7) days)
- Proportion of patients with mRS score 0 to 2 at 90 (±7) days(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)(From randomization to 90 (±7) days)
- Midline shift at 48 hours(From randomization to 48 hours)
- Proportion of patients with midline shift maximum > 5 mm within 48 hours (%)(From randomization to 48 hours)
- Relative hemispheric volume at 48 hours(From randomization to 48 hours)
- Net water uptake at 48 hours(From randomization to 48 hours)
- Proportion of patients with decompressive craniectomy after EVT(From randomization until the date of discharge, an average of 1 week)
- NIHSS score at 5-7 days or at early discharge(From randomization to 5-7 days (or at early discharge))
- EQ-5D-5L VAS at 90 (±7) days(From randomization to 90 (±7) days)
- Proportion of patients with symptomatic intracranial haemorrhage (SICH) within 48 hours after EVT(From randomization to 48 hours)
- Proportion of patients with any intracranial haemorrhage (ICH) within 48 hours after EVT(From randomization to 48 hours)
- Proportion of patients with pneumonia(From randomization until the date of discharge, an average of 1 week)
- Proportion of patients with gastrointestinal haemorrhage within 7 days after EVT(From randomization to 7 days)
- Incidence of any complications(From date of randomization until the date of discharge, an average of 1 week)
- Incidence of any (serious) adverse events(From randomization to 90 (±7) days)
研究者
YiLin
Deputy Director of Fujian Institute of Neurology
First Affiliated Hospital of Fujian Medical University
研究点 (1)
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