Acute Ischemic Stroke, Large Vessel Occlusion, Neuroprotective Drugs, Endovascular Treatment
Conditions
Brief summary
The goal of this clinical trial is to learn if semaglutide works to treat acute ischemic stroke (AIS). It will also learn about the safety of semaglutide in AIS. The main question it aims to answer is: Does semaglutide improve the 90-days functional outcome in participants with acute large vessel occlusion who receive the endovascular treatment (EVT)? Researchers will compare semaglutide injection to non-injection to see if semaglutide works to improve the functional outcome in participants with EVT. Participants will: * Receive 0.5mg semaglutide injection before (Day 0) and 1 week (Day 7) after EVT , or EVT alone. * Have additional blood test before and after EVT. * Receive neurological assessment before EVT, Day 1, Day 3, Day 5-7 after EVT or on hospital discharge (whichever earlier), Day 90±14 after EVT. Audio or video of the assessment may be recorded if possible. * Receive brain CT + CT angiogram + CT perfusion and MRI after EVT, where the CT scan may be repetitive.
Interventions
0.5mg semaglutide injection before and 1 week after endovascular treatment.
OTHERStandard medical treatment
Standard medical management
Sponsors
Chinese University of Hong Kong
Wei Hu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. LVO stroke at terminal ICA, M1 or dominant M2 with an LKW-to-randomization ≤24 hours 2. Age ≥ 18 years old 3. National Institute of Health Stroke Scale ≥ 6 at the time of brain imaging 4. Acute LVO stroke due to thromboembolism or intracranial stenosis 5. Patients who received computer tomographic or magnetic resonance angiography 6. ASPECTS ≥ 6 for patients with LKW-to-randomization ≤6 hours 7. Salvageable ischemic penumbra demonstrated by CT perfusion or MRI for patients with LKW-to-randomization between 6 and 24 hours 8. Informed consent obtained from patient or acceptable patient surrogate.
Exclusion criteria
1. Use of intravenous thrombolytic therapy (alteplase or tenecteplase) 2. Pre-stroke mRS \> 2 for patients \<80 years and \> 1 for patients ≥ 80 years old 3. Intracranial hemorrhage or brain tumour on initial imaging (except small meningiomas) 4. Simultaneous occlusion of bilateral anterior circulation, or both anterior and posterior circulation 5. Unstable hemodynamics on presentation that require resuscitation 6. Systolic blood pressure \>185mmHg or diastolic blood pressure \>110mmHg that cannot be controlled by antihypertensive drugs 7. Severe comorbid illness, e.g. terminal malignancy with life expectancy \<1 year 8. Pregnant or lactating female 9. Participation in another clinical trial 10. Contraindications to GLP1-RA, including history of allergy to GLP-1RA, family or personal history of multiple endocrine neoplasia, medullary thyroid or pancreatic carcinoma, or proliferative diabetic retinopathy 11. Blood glucose \<2.7 or \> 22.2 mmol/L; platelet count \<50x10\^9 /L; INR \>1.7 12. Patients with known estimated glomerular filtration rate of \<30ml/min/1.73m2 or creatinine \>3mg/dL (265.2µmol/L); chronic liver disease with Child's Pugh score C or above; or recurrent unexplained hypoglycemia. 13. Suspected or confirmed vasculitis of the central nervous system 14. Unable to complete 90-day follow-up assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The ordinal shift of modified Rankin Scale | 90±14 days after procedure | The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with functional independence outcome (mRS 0-1) at day 90 | 90±14 days after procedure | Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death) |
| Proportion of patients with functional independence outcome (mRS 0-2) at day 90 | 90±14 days after procedure | modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death) |
| Proportion of patients with ambulatory and self-care capable outcome (mRS 0-3) at day 90 | 90±14 days after procedure | Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death) |
| Health-related Quality of Life of Participants Assessed by EuroQol-5 Dimension-5 Level | 90±14 days after endovascular treatment | Participants rated themselves on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension was distributed from no problems at all to very serious problems. |
| Activities of Daily Living of Participants Assessed by Bathel Index | 90±14 days after procedure | 10 rating items, each of which is categorized into 2-3 out of 5 levels: Unable, Needs major help, Needs help, Needs minor help, and Independent, and each item has a different score for each level. Independence was positively correlated with the final score. |
| Neurological Function of Participants Assessed by National Institute of Health Stroke Scale | Day 1, Day 3, Day 5-7 after EVT (or at discharge, when the patient is discharged on day 5-7) | Zero indicates no stroke symptoms, 1-4 , 5-15, 16-20, 21-42 indicate minor, moderate, moderate to severe, and severe stroke, respectively. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intracranial Hemorrhage (ICH) | 48-72 hours after EVT | ICH means Heidelberg classification 2 or above intracerebral hemorrhage with increment of NIHSS ≥ 4. |
Countries
China
Contacts
Primary ContactWei Hu, MD, PhD
Outcome results
None listed