Head dOwn Position Before Endovascular Treatment for Large veSsel Occlusion (HOPES5)

Not Applicable

Recruiting

• Conditions: Ischemic Stroke

• Registration Number: NCT07172789
• Lead Sponsor: General Hospital of Shenyang Military Region

Brief Summary

Recent studies suggest that head-down positioning (HDP) intervention may improve outcomes in ischemic stroke. In the era of reperfusion therapy, a key protective strategy is to administer neuroprotective interventions before recanalization to reduce the loss of the ischemic penumbra, thereby salvaging more penumbral tissue after revascularization and ultimately improving clinical outcomes. Based on this concept, and considering the neuroprotective effects of HDP, the investigators hypothesize that HDP intervention prior to endovascular therapy (EVT) in patients with large vessel occlusion could improve clinical outcomes. This hypothesis is further supported by a recent clinical study (NCT03728738), which demonstrated that compared to a sitting up position (30°), a flat supine position (0°) before EVT significantly reduced the incidence of neurological deterioration prior to the procedure. Building on the above rationale, this trial aims to investigate the efficacy and safety of HDP intervention prior to EVT in patients with large vessel occlusion.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-02
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study First Posted: 2025-09-15
• Last Update Posted: 2025-09-15
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Age ≥ 18 years;
• Patients with acute large vessel occlusion scheduled for endovascular thrombectomy within 24 hours of symptom onset;
• Baseline National Institute of Health Stroke Scale (NIHSS) ≥ 6;
• Expected waiting time from randomization to femoral artery puncture is more than 30 minutes;
• ASPECTS/pc-ASPECTS score ≥ 6 on baseline non-contrast CT or DWI;
• Modified Rankin Scale score before stroke onset ≤ 1;
• Signed informed consent by patient or their legally authorized representative.

Exclusion Criteria

• Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
• Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
• Severe hypertension before randomization (systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg);
• Cardiac insufficiency (NYHA Class ≥II);
• Pregnancy, plan to get pregnant or during lactation;
• Patients at significant risk of aspiration (e.g., obvious nausea and vomiting);
• The estimated life expectancy is less than 6 months due to other serious diseases;
• Other conditions unsuitable for this clinical study assessed by researcher.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
early neurologic improvement (ENI)	24±8 hours	ENI was defined as more than 4-point decrease in NIHSS within 24±8 hours;

Secondary Outcome Measures

Name	Time	Method
proportion of intraparenchymal hemorrhage (PH)	24±8 hours	PH was defined as confluent bleeding occupying and causing mass effect
all-cause mortality	10±2 days
proportion of symptomatic intracranial hemorrhage	24±8 hours	symptomatic intracranial hemorrhage is defined as a NIHSS increase ≥4 caused by intracranial hemorrhage
proportion of good collateral circulation status	during the first angiography examination	good collateral circulation status was defined as ASITN/SIR grade 3-4.
Change in National Institutes of Health Stroke Scale (NIHSS)	10±2 days	the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
Changes in cerebral infarct volume	24±8 hours	infarct volume was measured by MRI-DWI
Changes in cerebral edema	24±8 hours	change in cerebral edema was measured based on middle shift on CT or MRI
proportion of modified Rankin Scale (mRS) 0-1	90±7 days	The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
proportion of modified Rankin Scale (mRS) 0-2	90±7 days	The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
ordinal distribution of modified Rankin Scale (mRS)	90±7 days	The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
new stroke or other vascular event(s)	90±7 days
percentage of severe adverse events	24±8 hours

Trial Locations

Locations (1)

Hui-Sheng Chen; 🇨🇳 Shenyang, None Selected, China