Myocardial Protection of Exenatide in AMI

Phase 4

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: exenatide BYETTA® (Amylin-Lilly); Drug: Saline

• Registration Number: NCT01580514
• Lead Sponsor: Kyunghee University Medical Center

Brief Summary

Experimental evidence suggests exenatide, a glucagon-like peptide 1 receptor analogue, has significant cardiovascular protective effects in various conditions. The investigators examined whether conventional use of exenatide at the time of primary percutaneous coronary intervention would reduce the infarct size in patients with ST-segment elevation myocardial infarction (STEMI).

Detailed Description

In this proof-of-concept trial, we assessed the effects of acute-phase adjunctive exenatide therapy in patients with STEMI.

Infarct size after STEMI was evaluated by both cardiac magnetic resonance image and cardiac biomarkers compared with standard treatment.

LV function was assessed by conventional and speckle tracking echocardiography. During 6-month follow up, the safety/tolerability of exenatide and clinical outcomes were also assessed.

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-04
• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-04-18
• Last Update Submitted: 2012-04-18
• Study First Posted: 2012-04-19
• Last Update Posted: 2012-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

• age between 20 and 79 years
• patients presenting with first ST-segment elevation myocardial infarction
• Thrombolysis in Myocardial Infarction [TIMI] flow grade 0)

Exclusion Criteria

• cardiac arrest
• ventricular fibrillation
• cardiogenic shock
• hemodynamic instability
• suspicious stent thrombosis
• left bundle branch block
• previous acute myocardial infarction
• previous coronary artery bypass operation
• significant valvular heart disease
• primary myocardial disease
• atrial fibrillation
• significant hepatic or renal dysfunction, hypoglycaemia,
• diabetic ketoacidosis
• active infection or chronic inflammatory disease
• malignancy
• women who were pregnant or who were of childbearing age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exenatide	exenatide BYETTA® (Amylin-Lilly)	Drug: Exenatide 10 μg subcutaneous and 10 μg intravenously injection of exenatide BYETTA® (Amylin-Lilly) 5 min before the onset of reperfusion. And twice daily 10 μg subcutaneous injection was continued on the following 2 days.
Saline	Saline	Drug: Saline 10 μg subcutaneous and 10 μg intravenously injection of equivalent volume of normal saline 5 min before the onset of reperfusion. And twice daily 10 μg subcutaneous injection was continued on the following 2 days.

Primary Outcome Measures

Name	Time	Method
Infarct size	1 month	Infarct size was assessed by measuring the release of creatine kinase-MB and troponin I during 72 hours and by performing cardiac magnetic resonance imaging on 1 month after infarction.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	6 month after primary PCI	Adverse events of exenatide such as hypoglycemia, nausea, vomiting, and chest pain aggravation were monitored during study period.
LV function	at admission and 6 month after primary PCI	Conventional and speckle tracking echocardiography was performed at initial presentation and 3 days and 6 months after primary PCI.
Clinical outcomes	6 months after primary PCI	During 6-month follow up, clinical outcomes such as all death, repeated myocardial infarction or repeated PCI were also assessed.

Trial Locations

Locations (1)

Kyung Hee University Hospital; 🇰🇷 Seoul, Korea, Republic of