跳至主要内容
临床试验/NCT02507128
NCT02507128Unknown不适用

Effects of Glucagon Like Peptide-1 on No-reflow in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Chen Wei Ren, MD1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
190
试验地点
1
主要终点
a change in the prevalence of no-reflow

研究概览

简要总结

The investigators planned to evaluate the effects of liraglutide on no-reflow in patients with acute ST-segment elevation myocardial infarction (STEMI).

详细描述

Acute myocardial infarction (AMI) is a major cause of mortality and morbidity. Primary percutaneous coronary intervention (PCI) is currently the most effective treatment strategy for AMI. Brisk thrombolysis in myocardial infarction (TIMI) grade 3 flow immediately after PCI in patients with AMI is associated with improved clinical outcomes compared with lower flow grades. However, myocardial reperfusion is suboptimal in many patients, mostly because of the 'no-reflow' phenomenon. No-reflow is defined as suboptimal myocardial reperfusion in part of the coronary circulation without angiographic evidence of mechanical vessel obstruction. To date, however, very few drugs have been shown to reverse established no-reflow.

Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and GLP-1 analogues were recently introduced for the treatment of acute myocardial infarction. GLP-1 has antioxidant and anti-inflammatory properties, and may protect endothelial function. Experimental studies have also revealed that GLP-1 or its analogues protect against reperfusion injury in pigs. Exenatide, a GLP-1 analogue, was reported to reduce reperfusion injury in patients with ST-segment elevation myocardial infarction. Similarly, liraglutide was reported to reduce cardiac rupture and infarct size and improve cardiac output in normal and diabetic mice. To date, however, there is no clinical evidence for the effects of liraglutide on no-reflow in patients with AMI. Therefore, the aim of this study was to evaluate the effects of liraglutide pretreatment on myocardial no-reflow of prime PCI in patients with AMI.

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with ST-segment elevation myocardial infarction were eligible for the study.

排除标准

  • Patients were excluded for the following reasons: unconscious at presentation; had cardiogenic shock, hypoglycaemia, or diabetic ketoacidosis; had a history of myocardial infarction, stent thrombosis, or renal insufficiency; or had previously undergone coronary artery bypass surgery.

研究组 & 干预措施

GLP-1 group

Experimental

The treatment started 30 min before PCI with a dose of 1.8 mg liraglutide (the treatment was administered in the ambulance).

干预措施: liraglutide (Drug)

Control group

Placebo Comparator

the treatment started 30 min before PCI with a dose of 1.8 mg placebo (the treatment was administered in the ambulance).

干预措施: placebo (Drug)

结局指标

主要结局

a change in the prevalence of no-reflow

时间窗: immediately after PCI

The primary efficacy variable was the prevalence of no-reflow assessed immediately post procedure.

次要结局

  • a change in troponin T(immediately after PCI, at 1,3,5 days after PCI)
  • a change in high-sensitivity C-reactive protein (hsCRP)(immediately after PCI, at 1,3,5 days after PCI)
  • a change in superoxide dismutase (SOD)(immediately after PCI, at 1,3,5 days after PCI)

研究者

发起方
Chen Wei Ren, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Chen Wei Ren, MD

Dr.

Chinese PLA General Hospital

研究点 (1)

Loading locations...

相似试验