Evaluation of acute mechanical revascularization in minor stroke (NIHSS score ⩽ 5) and large vessel occlusion: The MOSTE multicenter, randomized, clinical trial protocol

医学 改良兰金量表 临床终点 血运重建 冲程(发动机) 随机对照试验 大脑中动脉 内科学 中期分析 多中心试验 心脏病学 外科 缺血性中风 多中心研究 心肌梗塞 缺血 工程类 机械工程
作者
Caroline Arquizan,Bertrand Lapergue,Benjamin Gory,Julien Labreuche,Hilde Hénon,Jean‐François Albucher,Igor Sibon,Guillaume Turc,Sébastien Richard,Nasreddine Nouri,Christophe Cognard,Gaultier Marnat,Olivier Naggara,Federico Di Maria,Alain Duhamel,Tudor G. Jovin,Vincent Costalat
出处
期刊:International Journal of Stroke [SAGE]
卷期号:18 (10): 1255-1259 被引量:4
标识
DOI:10.1177/17474930231186039
摘要

Mechanical thrombectomy (MT) has become the standard of care for patients with acute ischemic stroke secondary to large vessel occlusion (LVO) of the anterior circulation. Conversely, its benefit in patients with National Institutes of Health Stroke Scale (NIHSS) score ⩽ 5 is unproven.To demonstrate the superiority of immediate MT plus best medical treatment (BMT) compared to BMT (with secondary MT in case of deterioration) for increasing the rate of modified Rankin Scale (mRS) score ⩽ 1 at 90 days after minor stroke (NIHSS score ⩽ 5) and anterior circulation LVO.To detect an absolute increase of 10% (80% power) in the 90-day mRS score = 0-1 rate in the MT + BMT group, by assuming an mRS score = 0-1 rate of 60% in the BMT group and by considering two interim efficacy/futility analyses (after study completion by 274 and 548 patients), 824 patients must be included by 36 centers in France, Spain, and the USA.MOSTE is an international, multicenter, prospectively randomized into two parallel (1:1) arms, open-label, with blinded endpoint trial. Eligibility criteria are diagnosis of acute ischemic stroke within 23 h of last-seen-well, NIHSS score ⩽ 5, and LVO in the anterior circulation (intracranial internal carotid artery, M1 or M1-M2 segment of the middle cerebral artery).The primary endpoint is the rate of excellent outcome at day 90 (mRS score = 0-1). Secondary endpoints include the rates of 90-day mRS score = 0-2 and score = 0, NIHSS score change, secondary MT, revascularization and infarct volume growth at 24 h, and quality of life and cognitive function at day 90. Safety outcomes (90-day all-cause mortality, procedural complications, symptomatic intracerebral hemorrhage, and rapid NIHSS score worsening) are recorded.The MOSTE trial will determine MT efficacy and safety in patients with minor stroke and LVO in the anterior circulation.MOSTE Trial. NCT03796468.
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