Abstract
BACKGROUND: Steroids 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 patients with acute ischemic stroke in the endovascular therapy era remains unknown. This trial investigates the efficacy and safety of low-dose methylprednisolone (2 mg/kg IV for 3 days) as adjunctive therapy for patients with acute ischemic stroke undergoing endovascular therapy within 24 hours from symptom onset. METHODS: The MARVEL (Methylprednisolone as Adjunctive Therapy for Acute Large Vessel Occlusion: A Randomized Double-Blind, Placebo-Controlled Trial in Patients Undergoing Endovascular Therapy) 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 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. RESULTS: The primary outcome is the ordinal shift in the modified Rankin scale score at 90 days. Secondary outcomes include 90-day functional independence (modified Rankin scale score, 0-2). The primary safety end points include mortality rate at 90 days and symptomatic intracerebral hemorrhage within 48 hours of endovascular therapy. CONCLUSION: The MARVEL trial will provide evidence of the efficacy and safety of low-dose methylprednisolone as adjunctive therapy for patients with anterior circulation large-vessel occlusion stroke undergoing endovascular therapy.