Myocardial Protection of Exenatide in AMI (EMPIRE)

• Number of Participants with Adverse Events [ Time Frame: 6 month after primary PCI ] [ Designated as safety issue: Yes ]
  Adverse events of exenatide such as hypoglycemia, nausea, vomiting, and chest pain aggravation were monitored during study period.
• LV function [ Time Frame: at admission and 6 month after primary PCI ] [ Designated as safety issue: No ]
  Conventional and speckle tracking echocardiography was performed at initial presentation and 3 days and 6 months after primary PCI.
• Clinical outcomes [ Time Frame: 6 months after primary PCI ] [ Designated as safety issue: No ]
  During 6-month follow up, clinical outcomes such as all death, repeated myocardial infarction or repeated PCI were also assessed.

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).

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.

• Drug: exenatide BYETTA® (Amylin-Lilly)

  After informed consent was obtained, patients who met the enrollment criteria were randomly assigned to either the control group or the exenatide group.

  Patients assigned to exenatide were treated with 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.

  Other Name: Saline
• Drug: Saline

  After informed consent was obtained, patients who met the enrollment criteria were randomly assigned to either the control group or the exenatide group.

  Patients assigned to saline were treated with 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.

  Other Name: Exenatide

• Active Comparator: Exenatide

  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.

  Intervention: Drug: exenatide BYETTA® (Amylin-Lilly)
• Placebo Comparator: 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.

  Intervention: Drug: Saline

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