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

NCT ID: NCT07202143

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Methylprednisolone sodium succinate group

Group Type: EXPERIMENTAL

Methylprednisolone sodium succinate

Intervention Type: 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 simulant (normal saline placebo)

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

YiLin

OTHER

Sponsor Role: lead

Responsible Party

YiLin

Deputy Director of Fujian Institute of Neurology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Neurology, the First Affiliated Hospital Fujian Medical University

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yi Lin, MD

Role: CONTACT

linyi7811@163.com

86-13615039153

Ying Fu, MD

Role: CONTACT

fuying1995@163.com

86-13920263588

Facility Contacts

Yi Lin, MD

Role: primary

linyi7811@163.com

13615039153

Other Identifiers

MRCTA, ECFAH of FMU [2025]887

Identifier Type: -

Identifier Source: org_study_id