Patients With a First Acute Myocardial Infarction to be Treated With Primary Percutaneous Coronary Intervention (PCI). Clinical Trial
Official title:
Effect of Additional Treatment With EXenatide in Patients With an Acute Myocardial Infarction (the EXAMI Trial)
Myocardial infarction (MI) causes loss of myocytes and may lead to loss of ventricular
function, morbidity and mortality. The most effective therapy is early reperfusion of the
ischemic myocardium by percutaneous coronary intervention (PCI). Reperfusion limits
myocardial ischaemic necrosis, but also induces inflammation, oxidative stress and calcium
overload: a process referred to as reperfusion injury leading to necrosis and apotosis.
Glucagon Like Peptide-1 (GLP-1) is an incretin hormone that has shown to activate
anti-apoptotic enzymes, reducing reperfusion injury. GLP-1 agonists have been demonstrated
to be cardioprotective in several animal studies and in a single small non-randomized
clinical study. In this pilot study we will assess the safety and efficacy of GLP-1 receptor
agonist Exenatide infusion compared to placebo in patients with an acute myocardial
infarction undergoing primary PCI.
A total of 40 patients will be included in this single centre prospective randomised placebo
controlled two-arm pilot study. Patients who are to undergo a primary PCI for a first acute
ST elevation myocardial infarction are randomly assigned to placebo or Exenatide 5ug bolus
in 30 minutes, followed by a continuous Exenatide infusion of 20ug/ 24 hours for 72 hours.
Blood samples are obtained for assessment of enzymatic infarct size and Exenatide levels.
Side effects of Exenatide are stringently monitored. Cardiac function will be measured using
Cardiac Magnetic Resonance Imaging (CMRI) and 3D echocardiography at 1 week and 4 months
post MI. Infarct size will be assessed by means of the final infarct size at 4 months post
MI as a percentage of the area at risk at 1 week post MI. Furthermore we will compare the
RNA profile of both groups.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment