It is uncertain whether intravenous methylprednisolone improves outcomes for acute anterior circulation large vessel occlusion (LVO) patients with a large infarct core. In this study, the investigators hypothesize that methylprednisolone plus endovascular thrombectomy (EVT) might be superior to EVT alone in patients with evidence of a large infarct volume. The primary objective of the study is to establish the efficacy of methylprednisolone with EVT in patients with acute anterior circulation LVO and a large infarct core.
Aged 18 to 85 years;
Clinically diagnosed acute ischemic stroke with screening NIHSS ≥6;
Time from last known well to randomization ≤24 hours;
Pre-stroke mRS score of 0-1;
Intracranial hemorrhage on NCCT or MRI;
Allergy to corticosteroids;
Allergy to contrast agents;
Severe infectious disease unsuitable for corticosteroid therapy or concurrent contraindications to corticosteroid treatment;
Parallel
Methylprednisolone sodium succinate
DrugIntravenous methylprednisolone sodium succinate will be administered at a dose of 2 mg/kg/day for 3 days, with a maximum daily dose of 160 mg (4 vials, 40 mg/vial). It is recommended that the initial dose be administered as soon as possible after randomization.
Placebo
DrugMatched intravenous placebo will be administered for 3 days, with a maximum daily dose of 4 vials.
The modified Rankin Scale score (mRS) 0-3
The proportion of mRS score 0-3 at 90 (±14) days
The distribution of the modified Rankin Scale scores
The shift analysis of mRS at 90±14 days (merged 0-1)
The modified Rankin Scale score (mRS) 0-4
The proportion of mRS score 0-4 at 90 (±14) days
The modified Rankin Scale score (mRS) 0-2
The proportion of mRS score 0-2 at 90 (±14) days
The modified Rankin Scale score (mRS) 0-1
The proportion of mRS score 0-1 at 90 (±14) days
SAFETY OUTCOME: Mortality
All-cause mortality within 90 days
SAFETY OUTCOME: Symptomatic intracranial hemorrhage (sICH)
Symptomatic intracranial hemorrhage (sICH) within 48 hours (according to Heidelberg criteria)
SAFETY OUTCOME: Any serious adverse events and steroid-related adverse events (hyperglycemia, infection, and gastrointestinal hemorrhage)
Safety will be assessed according to common terminology criteria for adverse events (CTCAE)
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