Myocardial Protection of Exenatide in AMI (EMPIRE)

Kyung Hee University

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction

Treatments: Drug: exenatide BYETTA® (Amylin-Lilly); Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01580514

KHMC-2012001

Details and patient eligibility

About

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 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.

Enrollment: 127 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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127 participants in 2 patient groups, including a placebo group

Exenatide

Active Comparator group

Description:

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.

Treatment:

Drug: exenatide BYETTA® (Amylin-Lilly)

Saline

Placebo Comparator group

Description:

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.

Treatment:

Drug: Saline