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Recruiting NCT06010641

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

No phase Interventional Stroke, Acute Ischemic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: head-down position.
Who it may be relevant to
Registry conditions: Stroke, Acute Ischemic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Other head-down position
    -20° Trendelenburg as an adjunct to guideline-based treatment,

Primary outcome measures

  • proportion of favorable functional outcome [Time frame: 90±7 days]
Secondary outcome measures (9)
  • proportion of excellent functional outcome [Time frame: 90±7 days]
  • ordinal distribution of modified Rankin Score (mRS) [Time frame: 90±7 days]
  • early neurological deterioration (END) [Time frame: 48±12 hours]
  • early neurological improvement (ENI) [Time frame: 48±12 hours]
  • Changes in National Institute of Health stroke scale (NIHSS) [Time frame: 48±12 hours]
  • Changes in National Institute of Health stroke scale (NIHSS) [Time frame: 10±2 days]
  • changes in infarct volume [Time frame: 48±12 hours]
  • new stroke or other vascular event(s) [Time frame: 90±7 days]
  • all-cause mortality [Time frame: 90±7 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Neurology, General Hospital of Northern Theater Command — Shenyang

Publications

  • Li X, Guo Z, Wang L, Wang Y, Nguyen T, Yang Y, Chen HS. Trendelenburg position for acute anterior circulation ischaemic stroke with large artery atherosclerosis aetiology (HOPES 3): rationale and design. Stroke Vasc Neurol. 2024 Nov 5;9(5):574-579. doi: 10.1136/svn-2023-002868. PMID 38296589

Identifiers

NCT: NCT06010641 · Y (2023) 148

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗