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

NCT07202143 | Recruiting Phase 3 DMC

• 1 other identifier: MRCTA, ECFAH of FMU [2025]887
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Large Infarct Core; Post-stroke Lymphocytopenia

Outcome Measures

Primary Outcomes (1)

• 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.

  From randomization to 90 (±7) days

Secondary Outcomes (19)

• 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

Other Outcomes (4)

• mRS ordinal shift at 1 year (scores 5 and 6 are merged)

  From randomization to 1 year

• Proportion of patients with mRS score 0 to 2 at 1 year

  From randomization to 1 year

• Proportion of patients with mRS score 0 to 1 at 1 year or return to pre-stroke mRS score (for patients with pre-stroke mRS > 1)

  From randomization to 1 year

Study Arms (2)

Methylprednisolone sodium succinate group

EXPERIMENTAL

Drug: Methylprednisolone sodium succinate

Methylprednisolone sodium succinate simulant (normal saline placebo)

PLACEBO COMPARATOR

Drug: Normal Saline

Interventions

Methylprednisolone sodium succinate DRUG

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.

Methylprednisolone sodium succinate group

Normal Saline DRUG

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.

Methylprednisolone sodium succinate simulant (normal saline placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• YiLin: lead

Study Sites (1)

Department of Neurology, the First Affiliated Hospital Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

MeSH Terms

Interventions

Methylprednisolone Hemisuccinate; Saline Solution

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Yi Lin, MD

CONTACT

86-13615039153; linyi7811@163.com

Ying Fu, MD

CONTACT

86-13920263588; fuying1995@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director of Fujian Institute of Neurology

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

CN (1)