An interventional study of liraglutide and placebo in Acute ST-segment Elevation Myocardial Infarction, sponsored by Chen Wei Ren, MD. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-07-23.
Sponsored by Chen Wei Ren, MD · Not applicable, Interventional, and Treatment
The investigators planned to evaluate the effects of liraglutide on no-reflow in patients with acute ST-segment elevation myocardial infarction (STEMI).
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.
688 studies on the registry are indexed under ST Elevation Myocardial Infarction; 184 are open to participants now.
This study's planned enrollment of 190 is close to the median of 194 across 439 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →Chen Wei Ren, MD is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Patients with ST-segment elevation myocardial infarction were eligible for the study.
Exclusion Criteria:
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.
The treatment started 30 min before PCI with a dose of 1.8 mg liraglutide (the treatment was administered in the ambulance).
Drug: liraglutide
the treatment started 30 min before PCI with a dose of 1.8 mg placebo (the treatment was administered in the ambulance).
Drug: placebo
Liraglutide were taken 30 min before PCI.
Also known as: glucagon like peptide-1
Placebo were taken 30 min before PCI.
a change in the prevalence of no-reflow
The primary efficacy variable was the prevalence of no-reflow assessed immediately post procedure.
Time frame: immediately after PCI
a change in troponin T
Secondary efficacy variable was troponin T level.
Time frame: immediately after PCI, at 1,3,5 days after PCI
a change in high-sensitivity C-reactive protein (hsCRP)
Secondary efficacy variable was high-sensitivity C-reactive protein level.
Time frame: immediately after PCI, at 1,3,5 days after PCI
a change in superoxide dismutase (SOD)
Secondary efficacy variable was superoxide dismutase level.
Time frame: immediately after PCI, at 1,3,5 days after PCI
differences in the incidences of treatment-emergent adverse events
Treatment-emergent adverse events (TEAEs): hypoglycaemia, pancreatitis, thyroid cancer
Time frame: immediately after PCI, at 1,3,5 days after PCI
This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Liraglutide
ST Elevation Myocardial Infarction →
Chen Wei Ren, MD