MARVEL: A Randomized Double‐Blind, Placebo‐Controlled Trial in Patients Undergoing Endovascular Therapy: Study Rationale and Design

Yang, Qingwu, Guo, Changwei, Yue, Chengsong, Yang, Jie, Li, Linyu, Peng, Zhouzhou, Hu, Jinrong, Huang, Jiandi, Song, Jiaxing, Huang, Jiacheng, Kong, Weilin, Yu, Nizhen, Yang, Dahong, Liu, Xiang, Wang, Duolao ORCID: https://orcid.org/0000-0003-2788-2464, Nogueira, Raul G., Li, Fengli, Nguyen, Thanh N. and Zi, Wenjie (2024) 'MARVEL: A Randomized Double‐Blind, Placebo‐Controlled Trial in Patients Undergoing Endovascular Therapy: Study Rationale and Design'. Stroke: Vascular and Interventional Neurology, e001090. (In Press)

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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.

Item Type:	Article
Subjects:	WL Nervous System > WL 300 General works (Include works on brain alone)
Faculty: Department:	Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):	https://doi.org/10.1161/svin.123.001090
SWORD Depositor:	JISC Pubrouter
Depositing User:	JISC Pubrouter
Date Deposited:	09 Feb 2024 11:34
Last Modified:	16 Feb 2024 16:10
URI:	https://archive.lstmed.ac.uk/id/eprint/23975

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