Efficacy Study of Glucagonlike Peptide-1 to Treat Reperfusion Injury

Not Applicable

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: liraglutide (Novo Nordisk, Bagsværd, Denmark); Drug: liraglutide placebo (Novo Nordisk)

• Registration Number: NCT02001363
• Lead Sponsor: Chen Wei Ren, MD

Brief Summary

The investigators planned to research the cardioprotective effects of intravenous liraglutide on reperfusion injury.

Detailed Description

Acute myocardial infarction is a major cause of mortality and morbidity. Primary percutaneous coronary intervention (pPCI) is currently the most effective treatment strategy in acute myocardial infarction. However, a sizable number of patients fail to restore optimal myocardial reperfusion, mostly because of the 'no-reflow' phenomenon. Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and recently GLP-1 analogues have been introduced for the treatment of type-2 diabetes. In experimental studies, GLP-1 or its analogues protect against reperfusion injury-induced cell death. Exenatide reduces reperfusion injury in patients with ST-segment elevation myocardial infarction. Liraglutide(GLP-1) is safe and effective to reduce weight,serum lipid levels and blood pressure. Liraglutide can reduce cardiac rupture (12 of 60 versus 46 of 60; P=0.0001) and infarct size (21±2% versus 29±3%, P=0.02) and improved cardiac output (12.4±0.6 versus 9.7±0.6 ml/min; P=0.002) in normal and diabetic mice. The investigators planned to research the cardioprotective effects of intravenous liraglutide administered prior to reperfusion and continued after restoration of coronary blood flow in patients with STEMI undergoing pPCI.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-27
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-04
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-05
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Patients were eligible if they were 18 years or older and presented within 12 h from the onset of symptoms and signs of ST-segment elevation myocardial infarction to the catheterization laboratory.

Exclusion Criteria

The patients were not considered for enrolment if they presented with unconsciousness, cardiogenic shock, hypoglycaemia, diabetic ketoacidosis, previous myocardial infarction, stent thrombosis, known renal insufficiency, or previous coronary artery bypass operation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
liraglutide	liraglutide (Novo Nordisk, Bagsværd, Denmark)	drug: liraglutide (Novo Nordisk, Bagsværd, Denmark) duration:7 days(from admission (primary percutaneous coronary intervention) to discharge) the intervention:once-daily subcutaneous liraglutide 0.6 mg for 2 days, then gradually increase the dosage, once-daily subcutaneous liraglutide 1.2 mg for 2 days ,once-daily subcutaneous liraglutide 1.8 mg for 3 days
liraglutide placebo	liraglutide placebo (Novo Nordisk)	drug:liraglutide placebo (Novo Nordisk) duration:7 days(from admission (primary percutaneous coronary intervention) to discharge) the intervention:once-daily subcutaneous liraglutide placebo 0.6 mg for 2 days, then gradually increase the dosage, once-daily subcutaneous liraglutide placebo 1.2 mg for 2 days ,once-daily subcutaneous liraglutide placebo 1.8 mg for 3 days

Primary Outcome Measures

Name	Time	Method
the salvage index measured by cardiac magnetic resonance	3 months after primary percutaneous coronary intervention	The primary endpoint was the salvage index measured by cardiac magnetic resonance after 3 months.

Secondary Outcome Measures

Name	Time	Method
major adverse cardiovascular events (MACE) after 3 months	3 months after Primary percutaneous coronary intervention	major adverse cardiovascular events (MACE) after 3 months: recurrent myocardial infarction, recurrent angina, revascularization, heart failure, cardiac death.; treatment-emergent adverse events (TEAEs): hypoglycemia, nausea, acute pancreatitis
final infarct size after 3 months	3 months after Primary percutaneous coronary intervention
the levels of high-sensitivity C-reactive protein (hsCRP)	3 months after Primary percutaneous coronary intervention
nitric oxide (NO) levels	3 months after Primary percutaneous coronary intervention

Trial Locations

Locations (1)

PLA General Hospital; 🇨🇳 Beijing, Beijing, China