title: Effect of additional treatment with EXenatide in patients with an Acute Myocardial Infarction (EXAMI): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Myocardial infarction causes irreversible loss of cardiomyocytes and may lead to loss of ventricular function, morbidity and mortality. Infarct size is a major prognostic factor and reduction of infarct size has therefore been an important objective of strategies to improve outcomes. In experimental studies, glucagon-like peptide 1 and exenatide, a long acting glucagon-like peptide 1 receptor agonist, a novel drug introduced for the treatment of type 2 diabetes, reduced infarct size after myocardial infarction by activating pro-survival pathways and by increasing metabolic efficiency.
  
  
  METHODS
  The EXAMI trial is a multi-center, prospective, randomized, placebo controlled trial, designed to evaluate clinical outcome of exenatide infusion on top of standard treatment, in patients with an acute myocardial infarction, successfully treated with primary percutaneous coronary intervention. A total of 108 patients will be randomized to exenatide (5 μg bolus in 30 minutes followed by continuous infusion of 20 μg/24 h for 72 h) or placebo treatment. The primary end point of the study is myocardial infarct size (measured using magnetic resonance imaging with delayed enhancement at 4 months) as a percentage of the area at risk (measured using T2 weighted images at 3-7 days).
  
  
  CONCLUSIONS
  If the current study demonstrates cardioprotective effects, exenatide may constitute a novel therapeutic option to reduce infarct size and preserve cardiac function in adjunction to reperfusion therapy in patients with acute myocardial infarction.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01254123.
authors: Department of Cardiology, VU University Medical Center, De Boelelaan 11171081 HV Amsterdam, The Netherlands.
authors: Martijn
authors: M
authors: Scholte
authors: Leo
authors: L
authors: Timmers
authors: Flip Jp
authors: FJ
authors: Bernink
authors: Robert N
authors: RN
authors: Denham
authors: Aernout M
authors: AM
authors: Beek
authors: Otto
authors: O
authors: Kamp
authors: Michaela
authors: M
authors: Diamant
authors: Anton Jg
authors: AJ
authors: Horrevoets
authors: Hans Wm
authors: HW
authors: Niessen
authors: Weena Jy
authors: WJ
authors: Chen
authors: Albert C
authors: AC
authors: van Rossum
authors: Niels
authors: N
authors: van Royen
authors: Pieter A
authors: PA
authors: Doevendans
authors: Yolande
authors: Y
authors: Appelman
mesh_terms: D000208:Acute Disease; D002985:Clinical Protocols; D000077270:Exenatide; D006801:Humans; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000503:physiopathology; D010455:Peptides / Q000627:therapeutic use*; D011446:Prospective Studies; D014688:Venoms / Q000627:therapeutic use*
chemical_list: D010455:Peptides; D014688:Venoms; D000077270:Exenatide