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NCT Number: NCT06010641

Trendelenburg Position for Acute Anterior Circulation Ischemic Stroke With Large Artery Atherosclerosis Etiology (HOPES 3)

The effect of head position as a nonpharmacological therapy on acute ischemic stroke (AIS) remains inconclusive. Recent HOPES2 (Head dOwn-Position for acutE moderate ischemic Stroke with large artery atherosclerosis) suggest the safety, feasibility, and potential benefit of the head-down position (HDP) in acute ischemic stroke. The current study aims to investigate the efficacy and safety of HDP in acute moderate ischemic stroke patients with large artery atherosclerosis.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Location status: Recruiting

Location contact

Hui-Sheng Chen, Ph.D.

CONTACT

[email protected]

+86 13352452086

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years old
  • Acute ischemic stroke confirmed by NCCT or MRI;
  • Moderate neurologic deficit (6≤ NIHSS ≤ 16) within 24 hours of onset, or progressing from mild (NIHSS ≤ 5) to moderate neurologic deficit (6≤ NIHSS ≤ 16) within 24 hours, requiring ≥ 4 point increase in NIHSS score although the onset time is beyond 24 hours;
  • Probable large artery atherosclerosis etiology based on the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria (responsible artery stenosis ≥ 50% or occlusion);
  • Anterior circulation stroke (internal carotid artery, M1 or M2 of middle cerebral artery);
  • First stroke onset or past stroke without obvious neurological deficit (mRS≤2);
  • Signed informed consent.

Exclusion criteria

  • Pre-stroke disability (mRS≥3);
  • Patients with disturbance of consciousness;
  • Patients who plan to undergo or have completed thrombolysis or mechanical thrombectomy;
  • Hemorrhagic stroke or combined ischemic and hemorrhagic stroke;
  • Serious comorbidity, such as liver or kidney insufficiency, malignant tumor, etc;
  • Other stroke etiologies, such as cardiogenic embolism, arteritis, arterial dissection, moyamoya disease, etc;
  • Previous history of intracerebral hemorrhage within 1 year;
  • Any contraindication to head-down position (e.g. active vomiting, pneumonia, uncontrolled heart failure);
  • Planned carotid or intracranial revascularization within 3 months;
  • Severe uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 100 mmHg);
  • Cardiac insufficiency (NYHA Class ≥II);
  • Pregnant or lactating women;
  • Comorbidity with other serious diseases;
  • Participating in other clinical trials within 3 months;
  • Patients not suitable for the study considered by researcher.

Treatment and study plan

head-down position

Other

-20° Trendelenburg as an adjunct to guideline-based treatment,

Primary outcomes

  1. proportion of favorable functional outcome

    Time frame: 90±7 days

    favorable functional outcome defined as modified Rankin Score (mRS) 0-2. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

Secondary outcomes

  1. proportion of excellent functional outcome

    Time frame: 90±7 days

    excellent functional outcome is defined as modified Rankin Score (mRS) 0-1. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

  2. ordinal distribution of modified Rankin Score (mRS)

    Time frame: 90±7 days

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

  3. early neurological deterioration (END)

    Time frame: 48±12 hours

    END is defined as more than 4-point increase in NIHSS within 48±12 hours, but was not a result of intracerebral hemorrhage

  4. early neurological improvement (ENI)

    Time frame: 48±12 hours

    ENI is defined as more than 4-point decrease in NIHSS within 48±12 hours

  5. Changes in National Institute of Health stroke scale (NIHSS)

    Time frame: 48±12 hours

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

  6. Changes in National Institute 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. changes in infarct volume

    Time frame: 48±12 hours

  8. new stroke or other vascular event(s)

    Time frame: 90±7 days

  9. all-cause mortality

    Time frame: 90±7 days

Other outcomes

  1. changes in cortical oxygen saturation determined by near infrared spectroscopy

    Time frame: 24±8 hours

  2. changes in cortical oxygen saturation determined by near infrared spectroscopy

    Time frame: 48±12 hours

  3. changes in serum biomarkers

    Time frame: 48±12 hours

  4. changes in serum biomarkers

    Time frame: 10±2 days

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

Trendelenburg Position for Acute Anterior Circulation Ischemic Stroke With Large Artery Atherosclerosis Etiology (HOPES 3): a Prospective, Randomized, Open-label, Blinded-endpoint, Multi-center Trial

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 24, 2023
Registry last updated
Apr 27, 2026

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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