Liraglutide in Acute Minor Ischemic Stroke or High-risk Transient Ischemic Attack Patients With Type 2 Diabetes Mellitus: A Prospective, Multicenter, Randomized, Blank-controlled，Blinded End-point Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,708
- 试验地点
- 1
- 主要终点
- Percentage of patients with the 90-day new stroke events (ischemic or hemorrhagic)
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of glucagon-like peptide-1 (GLP-1) analogue liraglutide in the treatment of acute minor stroke (National Institute of Health stroke scale, NIHSS ≤ 3) or high-risk transient ischemic attack (TIA) (ABCD2 score ≥ 4 ) patients with type 2 diabetes mellitus.
详细描述
The treatment arm will receive the starting dose of liraglutide of 0.6mg/d subcutaneously once daily, and the dose will be increased to 1.8mg/d in two weeks, and then continue to administrate this dose for 90 days. The control arm will not use liraglutide. Other types of GLP-1 analogues or degraded by dipeptidyl peptidase-IV (DPP-IV) inhibitors will be prohibited. Study visits will be performed at day 7, day 30±3 and at 90±7 day.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (male or female ≥ 50 years);
- •Acute ischemic stroke patients (NIHSS ≤ 3 at the time of randomization) with type 2 diabetes mellitus within 24 hours of symptoms onset;
- •High-risk TIA patients (ABCD2 score ≥ 4 at the time of randomization) with type 2 diabetes mellitus within 24 hours of onset;
- •First stroke, or prior stroke without sequel (mRS score ≤ 1) and does not affect the NIHSS score;
- •Informed consent signed.
排除标准
- •Diagnosis of hemorrhage brain disease on baseline head CT;
- •Iatrogenic and cardiogenic stroke;
- •Patients receiving thrombolysis or endovascular treatment;
- •Use of a GLP-1 analogue or any dipeptidyl peptidase-IV (DPP-IV) inhibitor within the 3 months prior to screening;
- •Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC);
- •Patients with pancreatitis or previous history of pancreatitis, inflammatory bowel disease and gastroparesis;
- •Pregnant, lactating women,or patients who are likely to have a pregnancy and plan to have one;
- •Allergic to liraglutide or excipients;
- •Congestive heart failure (NYHA class III-IV);
- •Severe liver and kidney dysfunction (AST/ALT is 3 times higher than the normal upper limit, serum creatinine is 3 times higher than the normal upper limit);
- •Patients with malignant tumors who are expected to have a survival period of less than three months;
- •Participated in other clinical trials of drugs within 3 months;
- •Researchers believe that patients who are not suitable for this clinical study.
研究组 & 干预措施
active
Active patients will receive liraglutide injections
干预措施: Liraglutide (Drug)
结局指标
主要结局
Percentage of patients with the 90-day new stroke events (ischemic or hemorrhagic)
时间窗: 90 days
Definition of ischemic stroke: An episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction. Either of the following is considered to be an ischemic stroke: a new focal neurologic deficit lasting for less than 24 hours and not attributable to a nonischemic cause but accompanied by neuroimaging evidence of new brain infarction; sudden onset of a new focal neurologic deficit, with clinical or imaging evidence of infarction lasting 24 hours or more and not attributable to a nonischemic cause. Definition of hemorrhagic stroke: Rapidly developing clinical signs of neurological dysfunction attributable to a focal collection of blood within the brain parenchyma, ventricular system or subarachnoid space that is not caused by trauma.
次要结局
- Percentage of patients with the 90-day new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)(90 days)
- Percentage of patients with the 90-day Modified Rankin Scale (mRS) ≤ 2(90 days)
研究者
Anding Xu
Dean of the First Affiliated Hospital of Jinan University
First Affiliated Hospital of Jinan University