drugset / Trial / NCT07202143

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

NCT07202143

Phase 3 Recruiting 200 enrolled YiLin
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-09-01
Primary completion
2026-09-30
Completion
2027-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylprednisolone Other / unclassified 2 mg/kg Intravenous