Effect of additional treatment with exenatide in patients with an acute myocardial infarction: the EXAMI trial)

INTERVENTION: Trade Name: Byetta Pharmaceutical Form: Solution for injection INN or Proposed INN: EXENATIDE CAS Number: 141758‐74‐9 Other descriptive name: Exenatide Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 5‐10 Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use CONDITION: Acute Myocardial Infartion to be treated with primary PCI ; MedDRA version: 12.0 Level: LLT Classification code 10000891 Term: Acute myocardial infarction PRIMARY OUTCOME: Main Objective: The primary objective is to determine whether additional treatment with exenatide in patients with acute myocardial infarction and treated with primary PCI, leads to a more preserved left ventricular function, compared to placebo in addition to primary PCI.; ; Primairy endpoint: Infarct size measured as the final infarct size on Delayed Enhancement (DE) MRI at 4 months as a percentage of the area at risk on T2 weighed MRI at 3‐5 days. Primary end point(s): Infarct size measured as the final infarct size on DE MRI at 4 months as a percentage of the area at risk on T2 weighed MRI at 3‐5 days. Secondary Objective: ‐To assess feasibility of this pilot trial; ‐To assess side effects of exenatide during acute myocardial infarction INCLUSION CRITERIA: ‐ >18 and < 80 years of age ‐ First myocardial infarction ‐ ST elevation of more than one mm in at least 2 separate leads on the electrocardiogram (ECG) ‐ Time from onset of complaints at least 2 hours at presentation. ‐ Delay between onset of sustained chestpain and PCI < 6 hours. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range