Myocardial Protection of Exenatide in AMI (EMPIRE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Weon Kim, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01580514
First received: April 13, 2012
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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).


Condition Intervention Phase
Myocardial Infarction
Drug: exenatide BYETTA® (Amylin-Lilly)
Drug: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • Infarct size [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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:
  • 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.


Enrollment: 127
Study Start Date: September 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
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.

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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580514

Locations
Korea, Republic of
Kyung Hee University Hospital
Seoul, Korea, Republic of, 130-872
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
Principal Investigator: Weon Kim, MD, PhD Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Weon Kim, associate professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01580514     History of Changes
Other Study ID Numbers: KHMC-2012001
Study First Received: April 13, 2012
Last Updated: April 18, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Kyunghee University Medical Center:
myocardial infarction
percutaneous coronary intervention
exenatide
reperfusion injury
cardiac magnetic resonance

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Exenatide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014