Myocardial Protection of Exenatide in AMI

Overview

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).

Full Title of Study: “Cardioprotective Effects of Exenatide in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention ; Results of Exenatide Myocardial Protection In REvascularization (EMPIRE) Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 2011

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Infarct size
    • Time Frame: 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 Measures

  • Number of Participants with Adverse Events
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 79 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kyunghee University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Weon Kim, associate professor – Kyunghee University Medical Center
  • Overall Official(s)
    • Weon Kim, MD, PhD, Principal Investigator, Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital

References

Timmers L, Henriques JP, de Kleijn DP, Devries JH, Kemperman H, Steendijk P, Verlaan CW, Kerver M, Piek JJ, Doevendans PA, Pasterkamp G, Hoefer IE. Exenatide reduces infarct size and improves cardiac function in a porcine model of ischemia and reperfusion injury. J Am Coll Cardiol. 2009 Feb 10;53(6):501-10. doi: 10.1016/j.jacc.2008.10.033.

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