Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke After Endovascular Treatment
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- The ordinal shift of modified Rankin Scale
研究概览
简要总结
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.
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
- Single (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
- •LVO stroke at terminal ICA, M1 or dominant M2 with an LKW-to-randomization ≤24 hours
- •Age ≥ 18 years old
- •National Institute of Health Stroke Scale ≥ 6 at the time of brain imaging
- •Acute LVO stroke due to thromboembolism or intracranial stenosis
- •Patients who received computer tomographic or magnetic resonance angiography
- •ASPECTS ≥ 6 for patients with LKW-to-randomization ≤6 hours
- •Salvageable ischemic penumbra demonstrated by CT perfusion or MRI for patients with LKW-to-randomization between 6 and 24 hours
- •Informed consent obtained from patient or acceptable patient surrogate.
排除标准
- •Use of intravenous thrombolytic therapy (alteplase or tenecteplase)
- •Pre-stroke mRS > 2 for patients <80 years and > 1 for patients ≥ 80 years old
- •Intracranial hemorrhage or brain tumour on initial imaging (except small meningiomas)
- •Simultaneous occlusion of bilateral anterior circulation, or both anterior and posterior circulation
- •Unstable hemodynamics on presentation that require resuscitation
- •Systolic blood pressure >185mmHg or diastolic blood pressure >110mmHg that cannot be controlled by antihypertensive drugs
- •Severe comorbid illness, e.g. terminal malignancy with life expectancy <1 year
- •Pregnant or lactating female
- •Participation in another clinical trial
- •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
- •Blood glucose <2.7 or > 22.2 mmol/L; platelet count <50x10^9 /L; INR >1.7
- •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.
- •Suspected or confirmed vasculitis of the central nervous system
- •Unable to complete 90-day follow-up assessment
研究组 & 干预措施
semaglutide
Participants will receive 0.5mg semaglutide injection before (Day 0) and 1 week (Day 7) after EVT. Additionally, they will receive antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines.
干预措施: Semaglutide 0.5 mg (Drug)
semaglutide
Participants will receive 0.5mg semaglutide injection before (Day 0) and 1 week (Day 7) after EVT. Additionally, they will receive antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines.
干预措施: Standard medical treatment (Other)
Standard medical management
Standard medical management. Participants will receive EVT, antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines.
干预措施: Standard medical treatment (Other)
结局指标
主要结局
The ordinal shift of modified Rankin Scale
时间窗: 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
次要结局
- Proportion of patients with functional independence outcome (mRS 0-1) at day 90(90±14 days after procedure)
- Proportion of patients with functional independence outcome (mRS 0-2) at day 90(90±14 days after procedure)
- Proportion of patients with ambulatory and self-care capable outcome (mRS 0-3) at day 90(90±14 days after procedure)
- 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))
- Health-related Quality of Life of Participants Assessed by EuroQol-5 Dimension-5 Level(90±14 days after endovascular treatment)
- Activities of Daily Living of Participants Assessed by Bathel Index(90±14 days after procedure)
研究者
Wei Hu
Professor
The First Affiliated Hospital of University of Science and Technology of China