Perispinal Etanercept to improve STroke Outcomes (PESTO): Protocol for a multicenter, international, randomized placebo-controlled trial.

IF 5.8 3区 医学 Q1 CLINICAL NEUROLOGY
European Stroke Journal Pub Date : 2024-09-01 Epub Date: 2024-04-27 DOI:10.1177/23969873241249248
Vincent Thijs, Geoffrey C Cloud, Nigel Gilchrist, Brooke Parsons, Forum Tilvawala, Jan Ho, Lara Ruthnam, Vimal Stanislaus, Nikola Sprigg, Marion Walker, Philip M Bath, Leonid Churilov, Julie Bernhardt
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引用次数: 0

Abstract

Rationale: A large proportion of stroke survivors will have long-lasting, debilitating neurological impairments, yet few efficacious medical treatment options are available. Etanercept inhibits binding of tumor necrosis factor to its receptor and is used in the treatment of inflammatory conditions. Perispinal subcutaneous injection followed by a supine, head down position may bypass the blood brain barrier. In observational studies and one small randomized controlled trial the majority of patients showed improvement in multiple post stroke impairments.

Aim: Perispinal Etanercept to improve STroke Outcomes (PESTO) investigates whether perispinal subcutaneous injection of etanercept improves quality of life and is safe in patients with chronic, disabling, effects of stroke.

Methods and design: PESTO is a multicenter, international, randomized placebo-controlled trial. Adult participants with a history of stroke between 1 and 15 years before enrollment and a current modified Rankin scale between 2 and 5 who are otherwise eligible for etanercept are randomized 1:1 to single dose injection of etanercept or placebo.

Study outcomes: The primary efficacy outcome is quality of life as measured using the Short Form 36 Health Inventory at day 28 after first injection. Safety outcomes include serious adverse events.

Sample size target: A total of 168 participants assuming an improvement of the SF-36 in 11% of participants in the control arm and in 30% of participants in the intervention arm, 80% power and 5% alpha.

Discussion: PESTO aims to provide level 1 evidence on the safety and efficacy of perispinal etanercept in patients with long-term disabling effects of stroke.

改善脑卒中预后的外周依那西普(PESTO):多中心、国际、随机安慰剂对照试验方案。
理由很大一部分中风幸存者会有长期的、使人衰弱的神经功能损伤,但目前几乎没有有效的药物治疗方案。Etanercept 可抑制肿瘤坏死因子与其受体的结合,用于治疗炎症。椎周皮下注射,然后采取仰卧、低头姿势,可绕过血脑屏障。在观察性研究和一项小型随机对照试验中,大多数患者中风后的多种功能障碍都有所改善。目的:"围皮下注射依那西普改善中风预后"(PESTO)研究了围皮下注射依那西普是否能改善中风慢性致残患者的生活质量,并且是否安全:PESTO 是一项多中心、国际性、随机安慰剂对照试验。研究结果:主要疗效指标是患者的生活质量和安全性:主要疗效结果为首次注射后第28天的生活质量,采用简表36健康量表进行测量。安全性结果包括严重不良事件:样本量目标:共 168 名参与者,假设对照组中 11% 的参与者和干预组中 30% 的参与者 SF-36 有所改善,功率为 80%,α为 5%:PESTO旨在为脑卒中长期致残患者使用围手术期依那西普的安全性和有效性提供1级证据。
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来源期刊
CiteScore
7.50
自引率
6.60%
发文量
102
期刊介绍: Launched in 2016 the European Stroke Journal (ESJ) is the official journal of the European Stroke Organisation (ESO), a professional non-profit organization with over 1,400 individual members, and affiliations to numerous related national and international societies. ESJ covers clinical stroke research from all fields, including clinical trials, epidemiology, primary and secondary prevention, diagnosis, acute and post-acute management, guidelines, translation of experimental findings into clinical practice, rehabilitation, organisation of stroke care, and societal impact. It is open to authors from all relevant medical and health professions. Article types include review articles, original research, protocols, guidelines, editorials and letters to the Editor. Through ESJ, authors and researchers have gained a new platform for the rapid and professional publication of peer reviewed scientific material of the highest standards; publication in ESJ is highly competitive. The journal and its editorial team has developed excellent cooperation with sister organisations such as the World Stroke Organisation and the International Journal of Stroke, and the American Heart Organization/American Stroke Association and the journal Stroke. ESJ is fully peer-reviewed and is a member of the Committee on Publication Ethics (COPE). Issues are published 4 times a year (March, June, September and December) and articles are published OnlineFirst prior to issue publication.
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