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

Not Applicable

Recruiting

• Conditions: Large Infarct Core; Post-stroke Lymphocytopenia
• Interventions: Drug: Methylprednisolone sodium succinate; Drug: Normal Saline

• Registration Number: NCT07202143
• Lead Sponsor: YiLin

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-23
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Primary Completion: 2026-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylprednisolone sodium succinate group	Methylprednisolone sodium succinate	-
Methylprednisolone sodium succinate simulant (normal saline placebo)	Normal Saline	-

Primary Outcome Measures

Name	Time	Method
All-cause mortality at 90 (±7) days	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.

Secondary Outcome Measures

Name	Time	Method
Time from randomization to the occurrence of death from any cause at 90 (±7) days	From randomization to 90 (±7) days	Secondary Efficacy Outcome; To evaluate death rate of the two treatment groups
mRS ordinal shift at 90 (±7) days (scores 5 and 6 are merged)	From randomization to 90 (±7) days	Secondary Efficacy Outcome
Proportion of patients with mRS score 0 to 4 at 90 (±7) days	From randomization to 90 (±7) days	Secondary Efficacy Outcome
Proportion of patients with mRS score 0 to 3 at 90 (±7) days	From randomization to 90 (±7) days	Secondary Efficacy Outcome
Proportion of patients with mRS score 0 to 2 at 90 (±7) days	From randomization to 90 (±7) days	Secondary Efficacy Outcome
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	Secondary Efficacy Outcome
Midline shift at 48 hours	From randomization to 48 hours	Secondary Efficacy Outcome
Proportion of patients with midline shift maximum > 5 mm within 48 hours (%)	From randomization to 48 hours	Secondary Efficacy Outcome
Relative hemispheric volume at 48 hours	From randomization to 48 hours	Secondary Efficacy Outcome
Net water uptake at 48 hours	From randomization to 48 hours	Secondary Efficacy Outcome
Proportion of patients with decompressive craniectomy after EVT	From randomization until the date of discharge, an average of 1 week	Secondary Efficacy Outcome
NIHSS score at 5-7 days or at early discharge	From randomization to 5-7 days (or at early discharge)	Secondary Efficacy Outcome
EQ-5D-5L VAS at 90 (±7) days	From randomization to 90 (±7) days	Secondary Efficacy Outcome
Proportion of patients with symptomatic intracranial haemorrhage (SICH) within 48 hours after EVT	From randomization to 48 hours	Primary Safety Outcome. Based on the modified Heidelberg Bleeding Classification.
Proportion of patients with any intracranial haemorrhage (ICH) within 48 hours after EVT	From randomization to 48 hours	Secondary Safety Outcome. Based on the modified Heidelberg Bleeding Classification.
Proportion of patients with pneumonia	From randomization until the date of discharge, an average of 1 week	Secondary Safety Outcome
Proportion of patients with gastrointestinal haemorrhage within 7 days after EVT	From randomization to 7 days	Secondary Safety Outcome
Incidence of any complications	From date of randomization until the date of discharge, an average of 1 week	Secondary Safety Outcome
Incidence of any (serious) adverse events	From randomization to 90 (±7) days	Secondary Safety Outcome

Trial Locations

Locations (1)

Department of Neurology, the First Affiliated Hospital Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China