Clinical Trial

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

Study acronym: MIRACLE-2
Recruiting Phase 3
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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.
Trial Details
NCT Number NCT07202143
Lead Sponsor YiLin
Conditions Large Infarct Core, Post-stroke Lymphocytopenia
Enrollment 200 participants
Start Date 2025-09-01
Primary Completion 2026-09-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-10-01