Exenatide for Myocardial Protection During Reperfusion Study

Exenatide for Myocardial Protection During Reperfusion Study: A Double-blind, Placebo-controlled Trial

This study aims to assess the effect of exenatide on myocardial injury in patients undergoing emergent percutaneous coronary intervention (PCI) for ST segment elevation myocardial infarction or heart attack (STEMI).

This is a Phase II randomized, double-blind, placebo-controlled study of patients with STEMI. Those who agree to participate will be immediately randomized to one of two groups: a 24-h infusion of exenatide; or a 24 h infusion of placebo. We will assess the ability of exenatide to reduce ischemic injury. This study will serve as safety evaluation study as well as a pilot for a larger multicentre trial powered for clinical outcomes.

Inclusion Criteria:

• Admission for primary PCI for STEMI, with enrollment within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥1mm in 2 or more limb leads, or ≥2mm in 2 or more precordial leads, or new onset LBBB) associated with acute chest pain or an elevation of cardiac enzymes.
• Antegrade TIMI 0 or 1 prior to PCI in the infarct-related artery
• Age ≥18 years

Exclusion Criteria:

• Symptomatic hypoglycemia (serum glucose <3.3 µmol/L; 60 mg/dl)
• Diabetes mellitus requiring insulin therapy
• Diabetic ketoacidosis
• Coronary anatomy warranting emergent coronary artery bypass graft surgery
• Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation)
• Need for hemodialysis
• Malignancy, HIV, or central nervous system disorder
• Cardiopulmonary resuscitation >15 min and compromised level of consciousness.
• Cardiogenic shock
• Current participation in any research study involving investigational drugs or devices
• Inability to give informed consent
• Inability to safely undergo cMRI (presence of cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, implanted drug infusion device, bone growth/fusion stimulator, cochlear, otologic, or ear implant, severe claustrophobia)
• Women of childbearing potential who are known to be pregnant or lactating or who have a positive pregnancy test on admission
• History of pancreatitis
• Known end stage renal failure or known eGFR <30 mL/min
• Currently taking exenatide (Byetta, Bydureon), liraglutide (Victoza), or any other GLP-1 agonist