drugset / Trial / NCT07202143
Methylprednisolone for Stroke With Large Infarct Core and Post-stroke Lymphocytopenia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylprednisolone | Other / unclassified | 2 mg/kg | Intravenous |