NCT07202143RecruitingPhase 3
Methylprednisolone for Stroke With Large Infarct Core and Post-stroke Lymphocytopenia
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
Source: ClinicalTrials.gov · Last updated 1 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 23 Sept 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- YiLin
- Diseases
- Stroke
- NCT number
- NCT07202143
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 200
- From 1 Sept 2025 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate \< 30 ml/min or serum creatinine \> 220 umol/L \[2.5 mg/ dL\]).
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurology, the First Affiliated Hospital Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.