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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Acute Ischemic
• Intervention / Treatment: Other: head-down position

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shenyang, China, 110016
    • Recruiting
    • Department of Neurology, General Hospital of Northern Theater Command
    • Contact: Hui-Sheng Chen, Ph.D.; Phone Number: +86 13352452086; Email: chszh@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Head-down position; head-down position as an adjunct to guideline-based treatment	Other: head-down position; -20° Trendelenburg as an adjunct to guideline-based treatment,
Other: control; guideline-based treatment	Other: head-down position; -20° Trendelenburg as an adjunct to guideline-based treatment,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of favorable functional outcome	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	90±7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
new stroke or other vascular event(s)		90±7 days
all-cause mortality		90±7 days
proportion of excellent functional outcome	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	90±7 days
ordinal distribution of modified Rankin Score (mRS)	The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome	90±7 days
early neurological deterioration (END)	END is defined as more than 4-point increase in NIHSS within 48±12 hours, but was not a result of intracerebral hemorrhage	48±12 hours
early neurological improvement (ENI)	ENI is defined as more than 4-point decrease in NIHSS within 48±12 hours	48±12 hours
Changes in National Institute of Health stroke scale (NIHSS)	the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.	48±12 hours
Changes in National Institute of Health stroke scale (NIHSS)	the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.	10±2 days
changes in infarct volume		48±12 hours

Other Outcome Measures

Outcome Measure	Time Frame
changes in cortical oxygen saturation determined by near infrared spectroscopy	24±8 hours
changes in cortical oxygen saturation determined by near infrared spectroscopy	48±12 hours
changes in serum biomarkers	48±12 hours
changes in serum biomarkers	10±2 days

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027

Study Registration Dates

• First Submitted: August 20, 2023
• First Submitted That Met QC Criteria: August 20, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Posture; Head-Down Tilt
• Other Study ID Numbers: Y (2023) 148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No