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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
436
Semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) analog, which has been found to have neuroprotective effects.
Normal saline is the placebo drug.
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
mRS at 90-days
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.
Time frame: 90 days postoperatively
National Institute of Health Stroke Scale (NIHSS) at 24 hours and 7-days
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.
Time frame: 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.
Infarct volume after 72 hours of treatment
assessed by magnetic resonance imaging brain scan
Time frame: 72 hours postoperatively
the incidence of surgical complications within 90 days postoperatively
Time frame: within 90 days postoperatively
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