Methylprednisolone added to clot removal for large stroke with low lymphocytes
Tests methylprednisolone with thrombectomy in adults with large acute ischemic strokes and low lymphocytes.
Plain-language title generated from the registry record
Registry title: Methylprednisolone for Stroke With Large Infarct Core and Post-stroke Lymphocytopenia
Key facts
- Where
- Fuzhou, ChinaSee the site
- Phase
- Phase 3
Where in China
- Department of Neurology, the First Affiliated Hospital Fujian Medical UniversityFuzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- YiLin
- Trial code
- NCT07202143
- Record updated
- 1 October 2025
- Original description
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.Read full original descriptionShow less
Methylprednisolone as Adjunct to Endovascular Thrombectomy for Acute Ischemic Stroke With Large Infarct Core and Post-stroke Lymphocytopenia -A Multicenter, Randomized, Double-blind, Placebo-controlled, Non-inferiority Trial
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.
Inclusion: 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: Intracranial hemorrhage confirmed by cranial CT or MRI; Allergic to contrast agents or glucocorticoids; Bleeding history (gastrointestinal and urinary tract bleeding) in recent 1 month; Life expectancy due to any advanced disease < 6 months; Systemic infectious disease; Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate < 30 ml/min or serum creatinine > 220 umol/L [2.5 mg/ dL]); mRS score > 2 before the time of last known well; Pregnant or lactating women; Participating in other clinical trials; The artery is tortuous so that the thrombectomy device cannot reach the target vessel; Follow-up is not expected to be completed; Intracranial aneurysm and arteriovenous malformation; Brain tumors with imaging mass effect.