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RecruitingNCT07172789Updated Sep 18, 2026

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

An interventional study of head down position in Ischemic Stroke, sponsored by General Hospital of Shenyang Military Region. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by General Hospital of Shenyang Military Region · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Ischemic Stroke

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03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 210 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

General Hospital of Shenyang Military Region is the lead sponsor of 78 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 by patient or their legally authorized representative.

Exclusion criteria

Exclusion Criteria:

  • Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
  • Severe hepatic or renal dysfunction, increase in or AST (more than 2 times of 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 ( Class ≥II);
  • Pregnancy, plan to get pregnant or during lactation;
  • Patients at significant risk of aspiration (e.g., obvious nausea and vomiting);
  • The estimated is less than 6 months due to other serious diseases;
  • Other conditions unsuitable for this clinical study assessed by researcher.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
210 participants (estimated)

Study arms

  • Experimental
    HDP

    the HDP group receive -20° Trendelenburg prior endovascular treatment.

    Other: head down position

  • No intervention
    Control

Interventions

  • Otherhead down position

    the patient is positioned at a -20° Trendelenburg

    Also known as: Trendelenburg

06

What researchers measure

Primary outcomes

  1. early neurologic improvement (ENI)

    ENI was defined as more than 4-point decrease in NIHSS within 24±8 hours;

    Time frame: 24±8 hours

Secondary outcomes

  1. proportion of good collateral circulation status

    good collateral circulation status was defined as ASITN/SIR grade 3-4.

    Time frame: during the first angiography examination

  2. Change in National Institutes of Health Stroke Scale (NIHSS)

    the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.

    Time frame: Immediately before endovascular treatment

  3. Change in National Institutes of Health Stroke Scale (NIHSS)

    the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.

    Time frame: 24±8 hours

  4. Changes in cerebral infarct volume

    infarct volume was measured by MRI-DWI

    Time frame: 24±8 hours

  5. Changes in cerebral edema

    change in cerebral edema was measured based on middle shift on CT or MRI

    Time frame: 24±8 hours

  6. Change in National Institutes of Health Stroke Scale (NIHSS)

    the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.

    Time frame: 10±2 days

  7. proportion of modified Rankin Scale (mRS) 0-1

    The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

    Time frame: 90±7 days

  8. proportion of modified Rankin Scale (mRS) 0-2

    The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

    Time frame: 90±7 days

  9. ordinal distribution of modified Rankin Scale (mRS)

    The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

    Time frame: 90±7 days

  10. new stroke or other vascular event(s)

    Time frame: 90±7 days

  11. percentage of severe adverse events

    Time frame: 24±8 hours

  12. proportion of symptomatic intracranial hemorrhage

    symptomatic intracranial hemorrhage is defined as a NIHSS increase ≥4 caused by intracranial hemorrhage

    Time frame: 24±8 hours

  13. proportion of intraparenchymal hemorrhage (PH)

    PH was defined as confluent bleeding occupying and causing mass effect

    Time frame: 24±8 hours

  14. all-cause mortality

    Time frame: 10±2 days

Other outcomes

  1. changes in dynamic cerebral autoregulation (dCA)

    dCA data include phase difference (the main parameter, determined as the phase shift angle ranging from 0° to 90°), gain (difference in the amplitude between CBFV and ABP), and the coherence function (indicates signal-to-noise ratio), which is determined according to previous report (Guo ZN, Guo WT, Liu J, et al. Changes in cerebral autoregulation and blood biomarkers after remote ischemic preconditioning.)

    Time frame: 24±8 hours

  2. changes in cortical oxygen saturation

    cortical oxygen saturation is determined by near infrared spectroscopy

    Time frame: 24±8 hours

  3. changes in serum biomarkers

    serum biomarkers include MMP-9, TNF-alpha, IL-1beta, etc.

    Time frame: 24±8 hours

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Fei ZX, Dai YJ, Wang XH, Chen HS. Head Down Position Before Endovascular Treatment for Large Vessel Occlusion: Clinical Trial Design. J Am Heart Assoc. 2026 Mar 17;15(6):e046853. doi: 10.1161/JAHA.125.046853. Epub 2026 Mar 4. PubMed 41778610 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07172789
Lead sponsor
General Hospital of Shenyang Military Region
Responsible party
Hui-Sheng Chen (Director, General Hospital of Shenyang Military Region) — Principal investigator
First posted
Sep 15, 2025
Start date
Sep 2, 2025
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Sep 18, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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