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

Phase 3RecruitingNCT07202143

YiLin200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Large Infarct Core Post-stroke Lymphocytopenia

Interventions

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.

Normal SalineDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

All-cause mortality at 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.

Time frame: From randomization to 90 (±7) days

Secondary Outcomes

Time from randomization to the occurrence of death from any cause at 90 (±7) days

Secondary Efficacy Outcome; To evaluate death rate of the two treatment groups

Time frame: From randomization to 90 (±7) days

mRS ordinal shift at 90 (±7) days (scores 5 and 6 are merged)

Secondary Efficacy Outcome

Time frame: From randomization to 90 (±7) days

Proportion of patients with mRS score 0 to 4 at 90 (±7) days

Secondary Efficacy Outcome

Time frame: From randomization to 90 (±7) days

Proportion of patients with mRS score 0 to 3 at 90 (±7) days

Secondary Efficacy Outcome

Time frame: From randomization to 90 (±7) days

Proportion of patients with mRS score 0 to 2 at 90 (±7) days

Secondary Efficacy Outcome

Time frame: 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)

Secondary Efficacy Outcome

Time frame: From randomization to 90 (±7) days

Midline shift at 48 hours

Secondary Efficacy Outcome

Time frame: From randomization to 48 hours

Proportion of patients with midline shift maximum > 5 mm within 48 hours (%)

Secondary Efficacy Outcome

Time frame: From randomization to 48 hours

Relative hemispheric volume at 48 hours

Secondary Efficacy Outcome

Time frame: From randomization to 48 hours

Net water uptake at 48 hours

Secondary Efficacy Outcome

Time frame: From randomization to 48 hours

Proportion of patients with decompressive craniectomy after EVT

Secondary Efficacy Outcome

Time frame: From randomization until the date of discharge, an average of 1 week

NIHSS score at 5-7 days or at early discharge

Secondary Efficacy Outcome

Time frame: From randomization to 5-7 days (or at early discharge)

EQ-5D-5L VAS at 90 (±7) days

Secondary Efficacy Outcome

Time frame: From randomization to 90 (±7) days

Proportion of patients with symptomatic intracranial haemorrhage (SICH) within 48 hours after EVT

Primary Safety Outcome. Based on the modified Heidelberg Bleeding Classification.

Time frame: From randomization to 48 hours

Proportion of patients with any intracranial haemorrhage (ICH) within 48 hours after EVT

Secondary Safety Outcome. Based on the modified Heidelberg Bleeding Classification.

Time frame: From randomization to 48 hours

Proportion of patients with pneumonia

Secondary Safety Outcome

Time frame: From randomization until the date of discharge, an average of 1 week

Proportion of patients with gastrointestinal haemorrhage within 7 days after EVT

Secondary Safety Outcome

Time frame: From randomization to 7 days

Incidence of any complications

Secondary Safety Outcome

Time frame: From date of randomization until the date of discharge, an average of 1 week

Incidence of any (serious) adverse events

Secondary Safety Outcome

Time frame: From randomization to 90 (±7) days

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts