Acute Ischemic Stroke
Conditions
Keywords
endovascular thrombectomy, semaglutide
Brief summary
The trial will be a randomized, double-blind, controlled, single-center trial. The purpose of this trial is to determine the efficacy and safety of semaglutide in improving neurological outcomes after endovascular thrombectomy for acute ischemic stroke. The patients in the treatment group will receive a subcutaneous injection of 0.5 mg semaglutide into the abdomen during endovascular thrombectomy. The patients in the control group will receive a similar-looking placebo. Patients will be randomized to the treatment or control group by the pharmacy, eliminating the selection bias. The patient and evaluator will be blind to the allocation of patients, further minimizing the bias.
Detailed description
Acute ischemic stroke (AIS) is a condition associated with high rates of disability and mortality worldwide, and its incidence continues to rise in our country. Endovascular thrombectomy (EVT), a major advance in stroke treatment in recent years, has gained widespread clinical application and become a standard treatment for AIS caused by large-vessel occlusion. EVT significantly improves neurological functional outcomes. However, in clinical practice, despite successful recanalization of the occluded artery, nearly half of patients do not achieve a favorable prognosis. There is a compelling need to identify novel neuroprotective strategies to enhance the effectiveness of EVT and improve patient quality of life. Recent evidence indicates that semaglutide reduces neuroinflammation and is associated with a decreased risk of stroke and fewer neurological complications in patients with diabetes. We anticipate that this trial will provide valuable insights into the potential role of semaglutide as a neuroprotective agent in patients with ischemic stroke.
Interventions
Semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) analog, which has been found to have neuroprotective effects.
DRUGNormal Saline
Normal saline is the placebo drug.
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Clinical or imaging diagnosis of acute ischemic stroke within 24 hours after onset; 2. Scheduled for endovascular thrombectomy; 3. Age ≥18 years; 4. Pre-stroke modified Rankin Scale (mRS) score ≤1; 5. Informed consent voluntarily signed by the patient or legal representative.
Exclusion criteria
1. Preoperative imaging diagnosis of intracranial hemorrhage, or history of intracranial hemorrhage within 3 months prior to surgery; 2. Contraindications for endovascular thrombectomy; 3. Recent history of ischemic stroke; 4. Fasting blood glucose \<3.9 mmol/L; 5. ASA classification of IV-V; 6. Severe organic heart disease or severe arrhythmia; 7. Pregnant or lactating women; 8. Contraindications to semaglutide or allergy to semaglutide.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mRS at 90-days | 90 days postoperatively | The primary endpoint is the degree of disability or dependence at 90 days as assessed by the mRS shift. A global measure of disability, the mRS comprises of seven grades ranging from 0 (no symptoms) to 6 (death). 0-2 points: indicating good neurological function recovery in patients; 3-6 points: indicating poor neurological function recovery in patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| National Institute of Health Stroke Scale (NIHSS) at 24 hours and 7-days | A decrease of ≥8 points in the NIHSS score from baseline to 24 hours and 7 days postoperatively, or a score of 0 to 1, indicates neurological improvement; an increase of ≥4 points indicates neurological deterioration. | NIHSS at 24 hours and 7-days will be recorded based on the patient's neurologic status by a health care professional to assess stroke severity post-procedure. |
| Infarct volume after 72 hours of treatment | 72 hours postoperatively | assessed by magnetic resonance imaging brain scan |
| the incidence of surgical complications within 90 days postoperatively | within 90 days postoperatively | — |
Countries
China
Contacts
Primary ContactPeiying Li MD，Ph.D
Outcome results
None listed