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NCT Number: NCT07172789

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

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hui-Sheng Chen

Shenyang, None Selected, 110016, China

Location status: Recruiting

Location contact

Zi-Ai Zhao, Ph.D.

CONTACT

[email protected]

86-2428897517

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

head down position

Other

the patient is positioned at a -20° Trendelenburg

Other names: Trendelenburg

Primary outcomes

  1. early neurologic improvement (ENI)

    Time frame: 24±8 hours

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

Secondary outcomes

  1. proportion of good collateral circulation status

    Time frame: during the first angiography examination

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

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

    Time frame: Immediately before endovascular treatment

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

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

    Time frame: 24±8 hours

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

  4. Changes in cerebral infarct volume

    Time frame: 24±8 hours

    infarct volume was measured by MRI-DWI

  5. Changes in cerebral edema

    Time frame: 24±8 hours

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

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

    Time frame: 10±2 days

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

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

    Time frame: 90±7 days

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

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

    Time frame: 90±7 days

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

  9. ordinal distribution of modified Rankin Scale (mRS)

    Time frame: 90±7 days

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

  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

    Time frame: 24±8 hours

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

  13. proportion of intraparenchymal hemorrhage (PH)

    Time frame: 24±8 hours

    PH was defined as confluent bleeding occupying and causing mass effect

  14. all-cause mortality

    Time frame: 10±2 days

Other outcomes

  1. changes in dynamic cerebral autoregulation (dCA)

    Time frame: 24±8 hours

    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.)

  2. changes in cortical oxygen saturation

    Time frame: 24±8 hours

    cortical oxygen saturation is determined by near infrared spectroscopy

  3. changes in serum biomarkers

    Time frame: 24±8 hours

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

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

Head dOwn Position Before Endovascular Treatment for Large veSsel Occlusion (HOPES5): a Prospective, Randomized, Open Label, Blinded-end Point, Multi-center Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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