Recruiting NCT07202143
Methylprednisolone for Stroke With Large Infarct Core and Post-stroke Lymphocytopenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methylprednisolone sodium succinate, Normal Saline.
- Who it may be relevant to
- Registry conditions: Large Infarct Core, Post-stroke Lymphocytopenia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Methylprednisolone sodium succinate
Methylprednisolone sodium succinate Intravenous injection of methylprednisolone sodium succinate (Chongqing Lummy Pharmaceutical Co., Ltd., 40mg/ vial) with a dose of 2mg/kg (maximum dose of 160mg), once daily, for three consecutive days. The initial study drug will be administered as soon as possible after randomization. It is recommended that the initial study drug administrated before arterial access closure, but it should not be delayed more than 2 hours after arterial access closure. - Drug Normal Saline
Intravenous injection of placebo (normal saline) (Chongqing Lummy Pharmaceutical Co., Ltd., 40mg/ bottle) with a dose of 2mg/kg (maximum dose of 160mg), once daily, for three consecutive days. The initial study drug will be administered as soon as possible after randomization. It is recommended that the initial study drug administrated before arterial access closure, but it should not be delayed more than 2 hours after arterial access closure.
Primary outcome measures
- All-cause mortality at 90 (±7) days [Time frame: From randomization to 90 (±7) days]
Secondary outcome measures (12)
- Time from randomization to the occurrence of death from any cause at 90 (±7) days [Time frame: From randomization to 90 (±7) days]
- mRS ordinal shift at 90 (±7) days (scores 5 and 6 are merged) [Time frame: From randomization to 90 (±7) days]
- Proportion of patients with mRS score 0 to 4 at 90 (±7) days [Time frame: From randomization to 90 (±7) days]
- Proportion of patients with mRS score 0 to 3 at 90 (±7) days [Time frame: From randomization to 90 (±7) days]
- Proportion of patients with mRS score 0 to 2 at 90 (±7) days [Time frame: From randomization to 90 (±7) days]
- Proportion of patients with mRS score 0 to 1 at 90 (±7) days or return to pre-stroke mRS score (for patients with prestroke mRS > 1) [Time frame: From randomization to 90 (±7) days]
- Midline shift at 48 hours [Time frame: From randomization to 48 hours]
- Proportion of patients with midline shift maximum > 5 mm within 48 hours (%) [Time frame: From randomization to 48 hours]
- Relative hemispheric volume at 48 hours [Time frame: From randomization to 48 hours]
- Net water uptake at 48 hours [Time frame: From randomization to 48 hours]
- Proportion of patients with decompressive craniectomy after EVT [Time frame: From randomization until the date of discharge, an average of 1 week]
- NIHSS score at 5-7 days or at early discharge [Time frame: From randomization to 5-7 days (or at early discharge)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Neurology, the First Affiliated Hospital Fujian Medical University — Fuzhou
Identifiers
NCT: NCT07202143 · MRCTA, ECFAH of FMU [2025]887