Head Down Position Before Endovascular Treatment for Large Vessel Occlusion: Clinical Trial Design

BACKGROUND: Head down position (HDP) shows potential benefits in acute ischemic stroke. Although -20° HDP appears safe, feasible, and potentially beneficial in patients with large artery atherosclerosis without reperfusion therapy, its value before endovascular treatment (EVT) in acute large vessel occlusion (LVO) stroke remains unknown. This trial aims to investigate the efficacy and safety of -20° HDP in patients with acute large vessel occlusion stroke before planned EVT. METHODS: The HOPES5 (Head Down Position Before Endovascular Treatment for Large Vessel Occlusion) trial is a prospective, randomized, open label, blinded-end point, multicenter study. Eligible patients with large vessel occlusion will be randomized 1:1 to -20° HDP or a flat (0°) head position before EVT, alongside standard guideline-based care. Primary outcome is early neurological improvement, defined as ≥4 National Institutes of Health Stroke Scale score reduction within 24 hours post EVT. Safety outcomes are HDP-related adverse events. Based on a prospective cohort, the proportion of early neurological improvement after EVT was ∼31%. A 20% absolute early neurological improvement increase (51%) in the HDP group is assumed. With 2-sided α=0.05, 80% power, 10% follow-up loss, and interim analysis alpha consumption, 210 patients (105 per group) are enrolled. All outcomes will have blinded assessment and will be analyzed on the intention-to-treat basis. The primary analysis will be stratified by age, sex, diabetes, baseline systolic blood pressure, location of index vessel, baseline National Institutes of Health Stroke Scale score, onset to HDP time, onset to thrombectomy time. CONCLUSIONS: The results of HOPES5 will provide initial evidence on the effect of HDP in patients with acute large vessel occlusion stroke before EVT within 24 h of onset. REGISTRATION: URL: https://clinicaltrials.gov/; Unique Identifier: NCT07172789.