Intracoronary Darbepoetin-alpha to Reduce The Infarct Size and Post-Infarct Remodeling
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

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
    

Detailed description: 
      [Eligibility Criteria]

      1. Patients, regardless of gender, at the age from 18 to 80 years were eligible if they had
      within 12 hours of onset of ST-segment myocardial infarction that was decided to treat with
      primary percutaneous coronary intervention.

      [Exclusion criteria]

        1. Uncontrolled congestive heart failure (Killip classes II and III, or cardiogenic shock)

        2. History of malignancy

        3. Serious hematological disease

        4. Current infectious disease requiring antibiotic therapy

        5. Baseline creatinine level > 2.0 mg/dL or dependence on dialysis

        6. Known hypersensitivity to or contraindication for heparin, aspirin, clopidogrel,
           sirolimus, everolimus, contrast medium and darbepoetin-α

      [Primary endpoint] Myocardial infarct size, estimated by measurement of peak levels of
      cardiac biomarker (CK-MB and troponin-I of the patients was followed for 48 hours at every 6
      hours)

      [Secondary end points]

        1. The infarct size, measured as the area of delayed enhancement seen with cardiac magnetic
           resonance (CMR) imaging on average four days after ST-segment elevation myocardial
           infarction (baseline)

        2. The proportion of area at risk (AAR) and salvaged myocardium, calculated by formula;
           [AAR - Infarct size] / AAR X 100 (%)

        3. The change of left ventricular ejection fraction (LVEF), LV end-diastolic volume
           (LVEDV), and LV end-systolic volume (LVESV) assessed by CMR between four days and four
           months

        4. LV remodeling index [(LVEDV at four months - baseline LVEDV) / baseline LVEDV X 100%]
           and the incidence of pathologic LV remodeling (LV remodeling index > 20%);

      [Safety endpoints] The incidence of composites of the cardiovascular endpoints (cardiac
      death, nonfatal myocardial infarction, stent thrombosis, ischemic stroke, hospital
      readmission with heart failure or ischemic symptoms, bleeding and urgent target lesion
      revascularization) assessed at four months.
    

Intervention name(s): Darbepoetin alfa; Control Saline
Intervention type(s): Drug; Drug
Intervention description(s): Darbepoetin alfa 300ug intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning and conventional treatment; Same volume of saline intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning and conventional treatment
Other intervention name(s): Nesp PFS Prefilled Syringe (Jeilkirin Pharm. Korea); 0.9% normal saline
Intervention MeSH terms: Darbepoetin alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myocardial infarction; Erythropoietin; Myocardial reperfusion injury