Ischemic StrokeNCT06313710
Head Down Position for Successful Recanalization of Anterior Circulation Large Vessel Occlusion (HOPES4)
A study testing head down position in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
This is a prospective, randomized, open label, blinded-end point, single-center study, aiming to investigate the effect of head down position in anterior circulation large vessel occlusion patients with successful recanalization after endovascular treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- head down position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2024to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Anterior circulation large vessel occlusion who received endovascular treatment within 24 hours of stroke onset;
- National Institute of Health Stroke Scale (NIHSS) ≥ 6 before endovascular treatment;
- Successful recanalization (mTICI 2b-3) after endovascular treatment;
- Cerebral circulation time based on DSA of the stroke side was slower than that of the healthy side after successful recanalization;
- ASPECTS ≥ 6 on CT or DWI;
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- Absence of parenchymal hematoma on CT images done in the angio suite immediately after the procedure;
- Modified Rankin Scale score before stroke onset ≤ 1;
- Signed informed consent by patient or their legally authorized representative.
Who cannot join
- Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
- Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
- After recanalization, severe and sustained (i.e., > 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg) refractory to antihypertensive medication;
- More than four retrieval attempts in the same vessel;
- Cardiac insufficiency (NYHA Class ≥II);
- Pregnancy, plan to get pregnant or during lactation;
- The estimated life expectancy is less than 6 months due to other serious diseases;
- Other conditions unsuitable for this clinical study assessed by researcher.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, 110016
About this study
Official title: Head Down Position for Successful Recanalization of Anterior Circulation Large Vessel Occlusion (HOPES3): a Prospective, Randomized, Open Label, Blinded-end Point, Single-center Study
This is a prospective, randomized, open label, blinded-end point, single-center study, aiming to investigate the effect of head down position in anterior circulation large vessel occlusion patients with successful recanalization after endovascular treatment.
- Conditions
- Ischemic Stroke
- 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
-10° Trendelenburg
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| low dose of head down position | Experimental | -10° Trendelenburg for 30 min Receives: Other: head down position |
| high dose of head down position | Experimental | -10° Trendelenburg for 60 min Receives: Other: head down position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 24±8 hours
Secondary outcomes (12)
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
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
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 improvement (ENI)
ENI is defined as more than 8-point decrease in NIHSS or 0 NIHSS within 24±8 hours
Measured: 24±8 hours
changes in infarct volume
infarct volume is measured by diffused weighted imaging
Measured: 24±8 hours
changes in cerebral edema
cerebral edema is determined by brain imaging
Measured: 24±8 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
new stroke or other vascular event(s)
Measured: 90±7 days
proportion of sympomatic intracranial hemorrhage
sympomatic intracranial hemorrhage is defined as a NIHSS increase ≥4 caused by intracranial hemorrhage
Measured: 24±8 hours
proportion of intraparenchymal hemorrhage (PH)
PH was defined as confluent bleeding occupying and causing mass effect
Measured: 24±8 hours
percentage of severe adverse events
Measured: 24±8 hours
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 posted15 Mar 2024
- Study start30 Aug 2024
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- 90 participants (actual)
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
- NCT06313710
- Sponsor's protocol ID
- Y (2024) 058
- Status last verified
- Nov 2025
- First submitted
- 5 Mar 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head Down Position for Successful Recanalization of Anterior Circulation Large Vessel Occlusion (HOPES3): a Prospective, Randomized, Open Label, Blinded-end Point, Single-center Study
- ClinicalTrials.gov ID
- NCT06313710
- Acronym / sponsor ID
- Y (2024) 058
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 15 Mar 2024 (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.
This is a prospective, randomized, open label, blinded-end point, single-center study, aiming to investigate the effect of head down position in anterior circulation large vessel occlusion patients with successful recanalization after endovascular treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| low dose of head down position | Experimental | Other: head down position-10° Trendelenburg for 30 min |
| high dose of head down position | Experimental | Other: head down position-10° Trendelenburg for 60 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18
- Anterior circulation large vessel occlusion who received endovascular treatment within 24 hours of stroke onset;
- National Institute of Health Stroke Scale (NIHSS) ≥ 6 before endovascular treatment;
- Successful recanalization (mTICI 2b-3) after endovascular treatment;
- Cerebral circulation time based on DSA of the stroke side was slower than that of the healthy side after successful recanalization;
Key exclusion criteria (8 listed)
- Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
- Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
- After recanalization, severe and sustained (i.e., > 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg) refractory to antihypertensive medication;
- More than four retrieval attempts in the same vessel;
- Cardiac insufficiency (NYHA Class ≥II);
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-10° Trendelenburg | Other | high dose of head down position, low dose of head down position |
Primary outcome
Changes in National Institute of Health stroke scale (NIHSS)
Time frame: 24±8 hours
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
12 secondary outcomes
proportion of excellent functional outcome
Time frame: 90±7 days
proportion of favorable functional outcome
Time frame: 90±7 days
ordinal distribution of modified Rankin Score (mRS)
Time frame: 90±7 days
early neurological improvement (ENI)
Time frame: 24±8 hours
changes in infarct volume
Time frame: 24±8 hours
changes in cerebral edema
Time frame: 24±8 hours
Changes in National Institute of Health stroke scale (NIHSS)
Time frame: 10±2 days
new stroke or other vascular event(s)
Time frame: 90±7 days
proportion of sympomatic intracranial hemorrhage
Time frame: 24±8 hours
proportion of intraparenchymal hemorrhage (PH)
Time frame: 24±8 hours
percentage of severe adverse events
Time frame: 24±8 hours
all-cause mortality
Time frame: 90±7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Ischemic Stroke, 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 9 inclusion and 8 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: finished, as of the sponsor's last update on 20 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in National Institute of Health stroke scale (NIHSS) (time frame: 24±8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2025.