Department of Neurology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.
The First Hospital of Jilin University, Changchun, Jilin, China.
Stroke Vasc Neurol. 2024 Nov 5;9(5):574-579. doi: 10.1136/svn-2023-002868.
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.
To investigate the benefit of HDP in acute moderate ischaemic stroke patients with large artery atherosclerosis (LAA).
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.
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.
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.
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.
NCT06010641.
头部位置作为一种非药物治疗方法对急性缺血性脑卒中（AIS）的影响仍不确定。我们最近的一项研究（Head dOwn-Position for acutE moderate ischaemic Stroke with large artery atherosclerosis，HOPES 2）表明，在 AIS 中采用头低位（HDP）是安全、可行且可能有益的。
研究头低位在大动脉粥样硬化（LAA）所致急性中度缺血性脑卒中患者中的获益。
基于双侧 0.05 水平的显著性，预计 600 例患者将在 80%的效能下得出优势假设，分层因素包括年龄、性别、糖尿病史、基线收缩压、指数血管位置、随机分组时的国立卫生研究院卒中量表评分、发病至随机分组时间、因早期神经恶化而进展为中度神经功能缺损以及责任血管狭窄程度。
Head dOwn-Position for acutE moderate ischaemic Stroke with large artery atherosclerosis（HOPES 3）是一项前瞻性、随机、开放标签、盲终点、多中心研究。入选的 AIS 患者将被随机分配（1:1）进入 HDP 组，接受-20°头低位加符合国家指南的标准医疗，或对照组仅接受符合国家指南的标准医疗。
主要结局为 90 天时的有利功能结局，定义为改良Rankin 量表 0-2 分。安全性结局为 HDP 相关不良事件。所有结局均将进行盲法评估，并进行意向治疗分析。
HOPES 3 的结果将为 24 小时内发病的 LAA 所致急性中度缺血性脑卒中患者或 24 小时内从轻度神经功能缺损进展的患者采用 HDP 的效果提供证据。
NCT06010641。
