Status:
RECRUITING
Methylprednisolone for Stroke With Large Infarct Core and Post-stroke Lymphocytopenia
Lead Sponsor:
YiLin
Conditions:
Large Infarct Core
Post-stroke Lymphocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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. T...
Eligibility Criteria
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.
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07202143
Start Date
September 1 2025
End Date
September 30 2027
Last Update
October 1 2025
Active Locations (1)
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1
Department of Neurology, the First Affiliated Hospital Fujian Medical University
Fuzhou, Fujian, China, 350005