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

Not Applicable

Recruiting

• Conditions: Stroke, Acute Ischemic
• Interventions: Other: head-down position

• Registration Number: NCT06010641
• Lead Sponsor: General Hospital of Shenyang Military Region

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-20
• Study First Submitted QC: 2023-08-20
• Study First Posted: 2023-08-24
• Study Start: 2024-01-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18
• Primary Completion: 2026-10-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	head-down position	guideline-based treatment
Head-down position	head-down position	head-down position as an adjunct to guideline-based treatment

Primary Outcome Measures

Name	Time	Method
proportion of favorable functional outcome	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 Outcome Measures

Name	Time	Method
new stroke or other vascular event(s)	90±7 days
early neurological deterioration (END)	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
changes in infarct volume	48±12 hours
proportion of excellent functional outcome	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
ordinal distribution of modified Rankin Score (mRS)	90±7 days	The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
early neurological improvement (ENI)	48±12 hours	ENI is defined as more than 4-point decrease in NIHSS within 48±12 hours
Changes in National Institute 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.
all-cause mortality	90±7 days

Trial Locations

Locations (1)

Department of Neurology, General Hospital of Northern Theater Command; 🇨🇳 Shenyang, China