Overview

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

Status:
Completed

Trial end date:
2013-02-01

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Seoul National University Bundang Hospital

Treatments:

Darbepoetin alfa
Epoetin Alfa

Criteria

Inclusion Criteria:

- Patients with ST-elevation myocardial infarction (MI) within 12 hours of onset

- Suitable coronary anatomy for PCI

- Age < 80 yrs

Exclusion Criteria:

- Uncontrolled congestive heart failure (Killip classes II and III, or cardiogenic
shock)

- History of malignancy

- Serious hematological disease

- Current infectious disease requiring antibiotic therapy

- Baseline creatinine level > 2.0 mg/dL or dependence on dialysis

- Known hypersensitivity to or contraindication for heparin, aspirin, clopidogrel,
sirolimus, everolimus, contrast medium and darbepoetin-α