Early methylprednisolone for large infarct strokes with low lymphocyte counts
Official title: 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
Run by First Affiliated Hospital of Fujian Medical University · NCT07202143 · Data updated 2026-11-12
This study will test whether giving methylprednisolone early, along with clot-removal treatment, helps adults with large anterior strokes and low blood lymphocyte counts live longer and recover better by 90 days.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2027 |
| Registry record updated | October 1, 2025 |
| Trial ID | NCT07202143 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) within 24 hours of last known well who have anterior large-vessel occlusion with ASPECTS <6 or core ≥50 ml, planned endovascular thrombectomy, baseline NIHSS ≥6, and peripheral lymphocyte count <0.8×10^9/L (with informed consent) are ideal candidates.
✕Probably not a fit
Patients without post-stroke lymphocytopenia, with intracranial hemorrhage, significant pre-stroke disability (mRS >2), pregnant individuals, or those outside the 24-hour window are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, placebo-controlled, non-inferiority Phase 3 trial testing early adjunctive methylprednisolone given with reperfusion therapy in patients who have large infarct cores and post-stroke lymphocytopenia. Eligible patients are adults within 24 hours of symptom onset with anterior circulation large-vessel occlusion, a small ASPECTS (<6) or large core volume (≥50 ml), planned endovascular thrombectomy, and low peripheral lymphocyte counts. Participants are randomized to receive methylprednisolone or saline placebo and are followed for safety and functional outcomes up to 90 days. The primary comparisons focus on survival and functional status at 90 days after stroke.
Why it matters
Potential benefit: If successful, early methylprednisolone could improve survival and 90-day functional outcomes for immunocompromised patients with large-core ischemic stroke when used alongside reperfusion therapy.
How similar studies have gone: Prior trials of corticosteroids in acute ischemic stroke have shown mixed or largely negative results, so applying methylprednisolone specifically to lymphocytopenic, large-core patients is a relatively novel and targeted approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Intracranial hemorrhage confirmed by cranial CT or MRI. * mRS score \> 2 before the time of last known well. * Pregnant or lactating women. * Allergic to contrast agents or glucocorticoids. * Participating in other clinical trials. * The artery is tortuous so that the thrombectomy device cannot reach the target vessel. * Bleeding history (gastrointestinal and urinary tract bleeding) in recent 1 month. * Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate \< 30 ml/min or serum creatinine \> 220 umol/L \[2.5 mg/ dL\]). * Life expectancy due to any advanced disease \< 6 months. * Follow-up is not expected to be completed. * Intracranial aneurysm and arteriovenous malformation. * Brain tumors with imaging mass effect. * Systemic infectious disease.
Where it's running
-
Department of Neurology, the First Affiliated Hospital Fujian Medical University
Fuzhou, Fujian, China Recruiting
Study contacts
- Study coordinator: Yi Lin, MD
- Email: linyi7811@163.com
- Phone: 86-13615039153
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.