Methylprednisolone as Adjunctive Therapy for Large Vessel Occlusion (MARVEL): a Randomized Double-blind, Placebo-controlled Trial in Patients undergoing Endovascular therapy: Study Rationale and Design

Abstract

AbstractBackgroundSteroids have pleiotropic neuroprotective actions including the regulation of inflammation and apoptosis which may influence the effects of ischemia on neurons, glial cells, and blood vessels. The effect of low-dose methylprednisolone in acute ischemic stroke (AIS) patients in the endovascular treatment (EVT) era remains unknown.ObjectiveThis trial investigates the efficacy and safety of low-dose methylprednisolone (2 mg/kg intravenous for 3 days) as adjunctive therapy for AIS patients undergoing mechanical thrombectomy (MT) within 24 hours from symptom onset.Methods and designMethylprednisolone as Adjunctive Therapy for Acute Large Vessel Occlusion (MARVEL) Trial is an investigator-initiated, prospective, randomized, double-blind, placebo-controlled multicenter clinical trial. Up to 1672 eligible patients with anterior circulation large vessel occlusion (LVO) stroke presenting within 24 hours from symptom onset are planned to be consecutively randomized to receive methylprednisolone or placebo in a 1:1 ratio across 82 stroke centers in China.OutcomesThe primary outcome is the ordinal shift in the modified Rankin scale (mRS) score at 90 days. Secondary outcomes include 90-day functional independence (mRS 0-2). The primary safety endpoints include mortality at 90 days and symptomatic intracerebral hemorrhage within 48 hours of MT.ConclusionThe MARVEL trial will provide evidence of the efficacy and safety of low-dose methylprednisolone as adjunctive therapy to anterior circulation LVO stroke patients undergoing endovascular treatment.Trial registry numberChiCTR2100051729 (www.chictr.org.cn).