Myocardial Protection of Exenatide in AMI

Myocardial Infarction Clinical Trial

— EMPIRE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580514
• Other study ID #: KHMC-2012001
• Status: Completed
• Phase: Phase 4
• First received: April 13, 2012
• Last updated: April 18, 2012
• Start date: September 2009
• Est. completion date: August 2011

Study information

• Verified date: April 2012
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size	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	No
Secondary	Number of Participants with Adverse Events	Adverse events of exenatide such as hypoglycemia, nausea, vomiting, and chest pain aggravation were monitored during study period.	6 month after primary PCI	Yes
Secondary	LV function	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	No
Secondary	Clinical outcomes	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	No