Stroke, Acute IschemicNCT06010641
Trendelenburg Position for Acute Anterior Circulation Ischemic Stroke With Large Artery Atherosclerosis Etiology (HOPES 3)
A study testing head-down position in people with Stroke, Acute Ischemic, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute Ischemic
- What is being tested?
- head-down position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2024to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, 110016
Hui-Sheng Chen, Ph.D., +86 13352452086, chszh@aliyun.com
About this study
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
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
- Being tested
- head-down position
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
head-down positionOther
-20° Trendelenburg as an adjunct to guideline-based treatment,
| Study group | Role | What they receive |
|---|---|---|
| Head-down position | Experimental | head-down position as an adjunct to guideline-based treatment Receives: Other: head-down position |
| control | Other | guideline-based treatment Receives: Other: head-down position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90±7 days
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 48±12 hours
early neurological improvement (ENI)
ENI is defined as more than 4-point decrease in NIHSS within 48±12 hours
Measured: 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.
Measured: 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.
Measured: 10±2 days
changes in infarct volume
Measured: 48±12 hours
new stroke or other vascular event(s)
Measured: 90±7 days
all-cause mortality
Measured: 90±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start10 Jan 2024
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, Acute IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010641
- Sponsor's protocol ID
- Y (2023) 148
- Status last verified
- Apr 2026
- First submitted
- 20 Aug 2023
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 38296589
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06010641
- Acronym / sponsor ID
- Y (2023) 148
- Conditions
- Stroke, Acute Ischemic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Head-down position | Experimental | Other: head-down positionhead-down position as an adjunct to guideline-based treatment |
| control | Other | Other: head-down positionguideline-based treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| head-down position-20° Trendelenburg as an adjunct to guideline-based treatment, | Other | Head-down position, control |
Primary outcome
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
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Derived from this study: PubMed 38296589Li 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing head-down position in people with Stroke, Acute Ischemic, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of favorable functional outcome (time frame: 90±7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06010641, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.