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

NCT ID: NCT06010641

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-10
• Study Completion Date: 2026-10-30

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.

Conditions

Stroke, Acute Ischemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Head-down position

head-down position as an adjunct to guideline-based treatment

Group Type: EXPERIMENTAL

head-down position

Intervention Type: OTHER

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

control

guideline-based treatment

Group Type: OTHER

head-down position

Intervention Type: OTHER

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

Interventions

head-down position

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Hui-Sheng Chen, Ph.D.

Role: primary

chszh@aliyun.com

+86 13352452086

References

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.

Reference Type: DERIVED

PMID: 38296589 (View on PubMed)

Other Identifiers

Y (2023) 148

Identifier Type: -

Identifier Source: org_study_id