Intracoronary Darbepoetin-alpha to Reduce The Infarct Size and Post-Infarct Remodeling

Summary

Prospective, randomized and open label trial Hypothesis * Infusion of intracoronary darbepoetin-alpha at the time of reperfusion may reduce infarct size and post-infarct pathologic left ventricular remodeling in patients with ST-segment elevation myocardial infarction. Methods * Randomization into control group or treatment group * Treatment group : Darbepoetin-alpha 300ug intracoronary bolus infusion via over-the-wire balloon system simultaneously with first balloon inflation and conventional treatment * Control group : conventional treatment Endpoints * peak CK-MB \& troponin levels : baseline,6h,12hr,18hr, 24hr, 36hr and 48hr * MRI at baseline : infarct size, area at risk and salvaged myocardium * MRI at 4 months : prevalence of pathologic left ventricle remodeling (definition: increase of end-diastolic volume index \> 20% compared to baseline) * safety endpoint : cardiac death, nonfatal myocardial infarction, stent thrombosis, ischemic stroke, hospital readmission with heart failure or ischemic symptom, bleeding and urgent target lesion revascularization

Timeline

Start

2009-11

Primary completion

2012-09

Completion

2013-02

Publications

• Suh JW, Yoon YE, Oh IY, Yoon CH, Cho YS, Youn TJ, Chae IH, Choi DJ. A single-center prospective randomized controlled trial evaluating the safety and efficacy of IntraCoronary Erythropoietin delivery BEfore Reperfusion: gauging infarct size in patients with acute ST-segment elevation myocardial infarction. Study design and rationale of the 'ICEBERG Trial'. Contemp Clin Trials. 2013 May;35(1):145-50. doi: 10.1016/j.cct.2013.03.001. Epub 2013 Mar 16.

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