A Phase 3 interventional study of Methylprednisolone sodium succinate and Normal Saline in Large Infarct Core and Post-stroke Lymphocytopenia, sponsored by YiLin. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by YiLin · Phase 3, Interventional, and Treatment
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.
This is the only study on the registry with YiLin as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Methylprednisolone sodium succinate
Drug: Normal Saline
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.
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.
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
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
mRS ordinal shift at 1 year (scores 5 and 6 are merged)
Tertiary Efficacy Outcome
Time frame: From randomization to 1 year
Proportion of patients with mRS score 0 to 2 at 1 year
Tertiary Efficacy Outcome
Time frame: 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)
Tertiary Efficacy Outcome
Time frame: From randomization to 1 year
EQ-5D-5L VAS at 1 year
Tertiary Efficacy Outcome
Time frame: From randomization to 1 year
Plan to share: Undecided
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