Effect of additional treatment with EXenatide in patients with an Acute Myocardial Infarction (EXAMI): study protocol for a randomized controlled trial

M. Scholte, L. Timmers, F.J.P. Bernink, R.N. Denham, A.M. Beek, O. Kamp, M. Diamant, A.J.G. Horrevoets, H.W.M. Niessen, W.J.Y. Chen, A.C. van Rossum, N. van Royen, P.A. Doevendans, Y.E.A. Appelman

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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).

DISCUSSION: 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.

TRIAL REGISTRATION: ClinicalTrials.gov: NCT01254123.

Original languageEnglish
Article number240
Number of pages8
JournalTrials
Volume12
DOIs
Publication statusPublished - 8 Nov 2011

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