Efficacy of Semaglutide in Improving Neurological Outcomes After Endovascular Thrombectomy for Acute Ischemic Stroke: A Randomized Double-Blind Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 436
- 试验地点
- 1
- 主要终点
- mRS at 90-days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical or imaging diagnosis of acute ischemic stroke within 24 hours after onset;
- •Scheduled for endovascular thrombectomy;
- •Age ≥18 years;
- •Pre-stroke modified Rankin Scale (mRS) score ≤1;
- •Informed consent voluntarily signed by the patient or legal representative.
排除标准
- •Preoperative imaging diagnosis of intracranial hemorrhage, or history of intracranial hemorrhage within 3 months prior to surgery;
- •Contraindications for endovascular thrombectomy;
- •Recent history of ischemic stroke;
- •Fasting blood glucose <3.9 mmol/L;
- •ASA classification of IV-V;
- •Severe organic heart disease or severe arrhythmia;
- •Pregnant or lactating women;
- •Contraindications to semaglutide or allergy to semaglutide.
研究组 & 干预措施
semaglutide group
The patients will receive a subcutaneous injection of 0.5 mg semaglutide into the abdomen during endovascular thrombectomy
干预措施: Semaglutide 0.5 mg (Drug)
placebo group
The patients in the control group will receive a similar-looking Normal Saline
干预措施: Normal Saline (Drug)
结局指标
主要结局
mRS at 90-days
时间窗: 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.
次要结局
- 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.)
- Infarct volume after 72 hours of treatment(72 hours postoperatively)
- the incidence of surgical complications within 90 days postoperatively(within 90 days postoperatively)