Myocardial Protection of Exenatide in AMI (EMPIRE)

April 18, 2012 updated by: Weon Kim, Kyunghee University Medical Center

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Exenatide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 month after primary PCI
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.
at admission and 6 month 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.
6 months after primary PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyunghee University Medical Center

Investigators

  • Principal Investigator: Weon Kim, MD, PhD, Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

April 13, 2012

First Submitted That Met QC Criteria

April 18, 2012

First Posted (ESTIMATE)

April 19, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 19, 2012

Last Update Submitted That Met QC Criteria

April 18, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KHMC-2012001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on exenatide BYETTA® (Amylin-Lilly)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe