Rationale The effect of the head position as a non-pharmacological therapy on acute ischaemic stroke (AIS) remains inconclusive. Our recent Head dOwn-Position for acutE moderate ischaemic Stroke with large artery atherosclerosis (HOPES 2) suggested the safety, feasibility and potential benefit of the head-down position (HDP) in AIS. Aim To investigate the benefit of HDP in acute moderate ischaemic stroke patients with large artery atherosclerosis (LAA). Sample size estimates Based on a two-sided 0.05 level of significance, 600 patients are expected to yield the superiority hypothesis with 80% power, stratified by age, sex, history of diabetes, baseline systolic blood pressure, location of index vessel, National Institutes of Health Stroke Scale Score at randomisation, onset to randomisation time, progression to moderate neurological deficit due to early neurological deterioration and degree of responsible vessel stenosis. Design Head dOwn-Position for acutE moderate ischaemic Stroke with large artery atherosclerosis(HOPES 3) is a prospective, randomised, open-label, blinded endpoint and multicentre study. Eligible patients who had an ischaemic stroke will be randomly assigned (1:1) into the HDP group receiving −20° Trendelenburg plus standard medical care in compliance with national guidelines, or control group only receiving standard medical care in compliance with national guidelines. Outcome The primary outcome is favourable functional outcome, defined as modified Rankin Scale 0–2 at 90 days. Safety outcomes are HDP-related adverse events. All outcomes will have blinded assessment and will be analysed on the intention-to-treat basis. Conclusions The results of HOPES 3 will provide evidence for the effect of HDP in acute moderate ischaemic stroke patients with LAA within 24 hours of onset or in patients with progression from mild neurological deficit within 24 hours. Trial registration number [NCT06010641][1]. No data are available. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT06010641&atom=%2Fsvnbmj%2Fearly%2F2024%2F01%2F30%2Fsvn-2023-002868.atom

中文翻译：

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特伦德伦伯卧位治疗伴有大动脉粥样硬化病因的急性前循环缺血性卒中（HOPES 3）：基本原理和设计

基本原理 头位作为非药物疗法对急性缺血性中风 (AIS) 的影响仍无定论。我们最近的头低位治疗伴有大动脉粥样硬化的急性中度缺血性中风（HOPES 2）表明头低位（HDP）在 AIS 中的安全性、可行性和潜在益处。目的 探讨 HDP 对伴有大动脉粥样硬化 (LAA) 的急性中度缺血性卒中患者的益处。样本量估计 基于双边 0.05 显着性水平，600 名患者预计会产生具有 80% 功效的优越性假设，按年龄、性别、糖尿病史、基线收缩压、指标血管位置分层，美国国立研究院随机化时的健康中风量表评分、随机化开始时间、由于早期神经功能恶化而进展为中度神经功能缺损以及相关血管狭窄程度。针对伴有大动脉粥样硬化的急性中度缺血性中风设计头下位（HOPES 3）是一项前瞻性、随机、开放标签、盲法终点和多中心研究。符合条件的缺血性卒中患者将被随机分配（1:1）至HDP组，接受-20°特伦德伦堡加符合国家指南的标准医疗护理，或对照组仅接受符合国家指南的标准医疗护理。结果 主要结果是良好的功能结果，定义为 90 天时改良 Rankin 量表 0-2。安全性结果是 HDP 相关的不良事件。所有结果都将进行盲法评估，并在意向治疗的基础上进行分析。结论 HOPES 3 的结果将为 HDP 对发病 24 小时内伴有左心耳的急性中度缺血性卒中患者或 24 小时内从轻度神经功能缺损进展的患者的疗效提供证据。试用注册号[NCT06010641][1]。无可用数据。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT06010641&atom=%2Fsvnbmj%2Fearly%2F2024%2F01%2F30%2Fsvn-2023-002868.atom