Clinical trial NCT06010641: Trendelenburg Position for Acute Anterior Circulation Ischemic Stroke With Large Artery Atherosclerosis Etiology (HOPES 3)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Acute Ischemic
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: proportion of favorable functional outcome
timeFrame: 90±7 days
Secondary outcomes:
measure: proportion of excellent functional outcome
timeFrame: 90±7 days
measure: ordinal distribution of modified Rankin Score (mRS)
timeFrame: 90±7 days
measure: early neurological deterioration (END)
timeFrame: 48±12 hours
measure: early neurological improvement (ENI)
timeFrame: 48±12 hours
measure: Changes in National Institute of Health stroke scale (NIHSS)
timeFrame: 48±12 hours
measure: Changes in National Institute of Health stroke scale (NIHSS)
timeFrame: 10±2 days
measure: changes in infarct volume
timeFrame: 48±12 hours
measure: new stroke or other vascular event(s)
timeFrame: 90±7 days
measure: all-cause mortality
timeFrame: 90±7 days
Other outcomes:
measure: changes in cortical oxygen saturation determined by near infrared spectroscopy
timeFrame: 24±8 hours
measure: changes in cortical oxygen saturation determined by near infrared spectroscopy
timeFrame: 48±12 hours
measure: changes in serum biomarkers
timeFrame: 48±12 hours
measure: changes in serum biomarkers
timeFrame: 10±2 days
Locations:
city: Shenyang
country: China
facility: Department of Neurology, General Hospital of Northern Theater Command
Study officials:
References: