Methylprednisolone Adjunctive to Endovascular Thrombectomy for Stroke

Condition(s) studied

Investigational drug(s) / intervention(s)

Methylprednisolone sodium succinate: Intravenous injection of methylprednisolone sodium succinate (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.

Placebo: Intravenous injection of placebo (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.

Study summary

The efficacy and safety of methylprednisolone in acute ischemic stroke patients with large infarct cores (ASPECTS score \< 6 or infarct volume ≥50 mL) due to anterior circulation large vessel occlusion have not been clearly established. This is a multi-center, randomized, double-blind, placebo-controlled trial to investigate early combination therapy with methylprednisolone for reperfusion in acute large core infarction.

Eligibility

Primary outcome measure(s)

• All-cause mortality at 90 (±14) days — From randomization to 90 (±14) days
  Primary Efficacy Outcome. Defined as the number of any cause deaths observed divided by the number of subjects observed over the 90-day study period.

Trial sites (99)

+ 59 more sites — see the full list on the official registry below.

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