Intracoronary Darbepoetin-alpha to Reduce The Infarct Size and Post-Infarct Remodeling
Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
Participant gender:
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