Ischemic StrokeNCT07172789
Head dOwn Position Before Endovascular Treatment for Large veSsel Occlusion (HOPES5)
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
Recent studies suggest that head-down positioning (HDP) intervention may improve outcomes in ischemic stroke. In the era of reperfusion therapy, a key protective strategy is to administer neuroprotective interventions before recanalization to reduce the loss of the ischemic penumbra, thereby salvaging more penumbral… 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
- 210 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2025to 30 Sep 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;
- Patients with acute large vessel occlusion scheduled for endovascular thrombectomy within 24 hours of symptom onset;
- Baseline National Institute of Health Stroke Scale (NIHSS) ≥ 6;
- Expected waiting time from randomization to femoral artery puncture is more than 30 minutes;
- ASPECTS/pc-ASPECTS score ≥ 6 on baseline non-contrast CT or DWI;
- 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;
- Severe hypertension before randomization (systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg);
- Cardiac insufficiency (NYHA Class ≥II);
- Pregnancy, plan to get pregnant or during lactation;
- Patients at significant risk of aspiration (e.g., obvious nausea and vomiting);
- 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hui-Sheng Chen
Shenyang, None Selected, 110016
Zi-Ai Zhao, Ph.D., 86-2428897517, zhaoziai@hotmail.com
About this study
Official title: Head dOwn Position Before Endovascular Treatment for Large veSsel Occlusion (HOPES5): a Prospective, Randomized, Open Label, Blinded-end Point, Multi-center Study
Recent studies suggest that head-down positioning (HDP) intervention may improve outcomes in ischemic stroke. In the era of reperfusion therapy, a key protective strategy is to administer neuroprotective interventions before recanalization to reduce the loss of the ischemic penumbra, thereby salvaging more penumbral tissue after revascularization and ultimately improving clinical outcomes. Based on this concept, and considering the neuroprotective effects of HDP, the investigators hypothesize that HDP intervention prior to endovascular therapy (EVT) in patients with large vessel occlusion could improve clinical outcomes. This hypothesis is further supported by a recent clinical study (NCT03728738), which demonstrated that compared to a sitting up position (30°), a flat supine position (0°) before EVT significantly reduced the incidence of neurological deterioration prior to the procedure. Building on the above rationale, this trial aims to investigate the efficacy and safety of HDP intervention prior to EVT in patients with large vessel occlusion.
- 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
Also called Trendelenburg
the patient is positioned at a -20° Trendelenburg
| Study group | Role | What they receive |
|---|---|---|
| HDP | Experimental | the HDP group receive -20° Trendelenburg prior endovascular treatment. Receives: Other: head down position |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
early neurologic improvement (ENI)
ENI was defined as more than 4-point decrease in NIHSS within 24±8 hours;
Measured: 24±8 hours
Secondary outcomes (14)
proportion of good collateral circulation status
good collateral circulation status was defined as ASITN/SIR grade 3-4.
Measured: during the first angiography examination
Change in National Institutes of Health Stroke Scale (NIHSS)
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
Measured: Immediately before endovascular treatment
Change in National Institutes 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
Changes in cerebral infarct volume
infarct volume was measured by MRI-DWI
Measured: 24±8 hours
Changes in cerebral edema
change in cerebral edema was measured based on middle shift on CT or MRI
Measured: 24±8 hours
Change in National Institutes 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
proportion of modified Rankin Scale (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 modified Rankin Scale (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 Scale (mRS)
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Measured: 90±7 days
new stroke or other vascular event(s)
Measured: 90±7 days
percentage of severe adverse events
Measured: 24±8 hours
proportion of symptomatic intracranial hemorrhage
symptomatic 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
all-cause mortality
Measured: 10±2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start2 Sep 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 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 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
- 210 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
- NCT07172789
- Sponsor's protocol ID
- Y (2025) 320
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fei ZX, Dai YJ, Wang XH, Chen HS. Head Down Position Before Endovascular Treatment for Large Vessel Occlusion: Clinical Trial Design. J Am Heart Assoc. 2026 Mar 17;15(6):e046853. doi: 10.1161/JAHA.125.046853. Epub 2026 Mar 4.
PubMed 41778610
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head dOwn Position Before Endovascular Treatment for Large veSsel Occlusion (HOPES5): a Prospective, Randomized, Open Label, Blinded-end Point, Multi-center Study
- ClinicalTrials.gov ID
- NCT07172789
- Acronym / sponsor ID
- Y (2025) 320
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 15 Sep 2025 (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.
Recent studies suggest that head-down positioning (HDP) intervention may improve outcomes in ischemic stroke. In the era of reperfusion therapy, a key protective strategy is to administer neuroprotective interventions before recanalization to reduce the loss of the ischemic penumbra, thereby salvaging more penumbral tissue after revascularization and ultimately improving clinical outcomes. Based on this concept, and considering the neuroprotective effects of HDP, the investigators hypothesize that HDP intervention prior to endovascular therapy (EVT) in patients with large vessel occlusion could improve clinical outcomes. This hypothesis is further supported by a recent clinical study (NCT03728738), which demonstrated that compared to a sitting up position (30°), a flat supine position (0°) before EVT significantly reduced the incidence of neurological deterioration prior to the procedure. Building on the above rationale, this trial aims to investigate the efficacy and safety of HDP intervention prior to EVT in patients with large vessel occlusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HDP | Experimental | Other: head down positionthe HDP group receive -20° Trendelenburg prior endovascular treatment. |
| Control | No intervention | – |
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;
- Patients with acute large vessel occlusion scheduled for endovascular thrombectomy within 24 hours of symptom onset;
- Baseline National Institute of Health Stroke Scale (NIHSS) ≥ 6;
- Expected waiting time from randomization to femoral artery puncture is more than 30 minutes;
- ASPECTS/pc-ASPECTS score ≥ 6 on baseline non-contrast CT or DWI;
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;
- Severe hypertension before randomization (systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg);
- Cardiac insufficiency (NYHA Class ≥II);
- Pregnancy, plan to get pregnant or during lactation;
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 positionAlso: Trendelenburgthe patient is positioned at a -20° Trendelenburg | Other | HDP |
Primary outcome
early neurologic improvement (ENI)
Time frame: 24±8 hours
ENI was defined as more than 4-point decrease in NIHSS within 24±8 hours;
14 secondary outcomes
proportion of good collateral circulation status
Time frame: during the first angiography examination
Change in National Institutes of Health Stroke Scale (NIHSS)
Time frame: Immediately before endovascular treatment
Change in National Institutes of Health Stroke Scale (NIHSS)
Time frame: 24±8 hours
Changes in cerebral infarct volume
Time frame: 24±8 hours
Changes in cerebral edema
Time frame: 24±8 hours
Change in National Institutes of Health Stroke Scale (NIHSS)
Time frame: 10±2 days
proportion of modified Rankin Scale (mRS) 0-1
Time frame: 90±7 days
proportion of modified Rankin Scale (mRS) 0-2
Time frame: 90±7 days
ordinal distribution of modified Rankin Scale (mRS)
Time frame: 90±7 days
new stroke or other vascular event(s)
Time frame: 90±7 days
percentage of severe adverse events
Time frame: 24±8 hours
proportion of symptomatic intracranial hemorrhage
Time frame: 24±8 hours
proportion of intraparenchymal hemorrhage (PH)
Time frame: 24±8 hours
all-cause mortality
Time frame: 10±2 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 18 Sep 2026.
- Derived from this study: PubMed 41778610Fei ZX, Dai YJ, Wang XH, Chen HS. Head Down Position Before Endovascular Treatment for Large Vessel Occlusion: Clinical Trial Design. J Am Heart Assoc. 2026 Mar 17;15(6):e046853. doi: 10.1161/JAHA.125.046853. Epub 2026 Mar 4.
- 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.
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 7 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: looking for participants now, as of the sponsor's last update on 18 Sep 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?
early neurologic improvement (ENI) (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?
On the ClinicalTrials.gov record for NCT07172789, 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 18 Sep 2026.