Early methylprednisolone for large infarct strokes with low lymphocyte counts

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

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
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital of Fujian Medical University (Academic / other)
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT07202143 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Fuzhou, Fujian

• Department of Neurology, the First Affiliated Hospital Fujian Medical University — Fuzhou, Fujian, China (Recruiting)

Study contacts

• Study coordinator: Yi Lin, MD

Conditions Large Infarct Core; Post-stroke Lymphocytopenia