Acute Myocardial Infarction
Conditions
Interventions
Epoetin-beta(12,000 unit) treatment group
Epoetin-beta (6,000 unit) treatment group
Placebo treatment group
Sponsors
Cardioprotection Workshop
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with first-time myocardial infarction 2) Patients with ST-elevation acute myocardial infarction (AMI) who have successful reperfusion by PCI within 12 hours after the symptom onset. 3) Patients whose ejection fraction at enrollment is <50% on UCG or LVG. 4) Age: over 20 years old, under 80 years old 5) Patients who agreed with participation to the trial in writing.
Exclusion criteria
Exclusion criteria: 1) Patients with significant stenotic lesions which require revascularization. 2) Patients who resulted in obviously impaired reperfusion. 3) Patients with Killip class III or IV, or cardiogenic shock at admission. 4) Patients with advanced renal or hepatic dysfunction (Cre more than 2mg/dl, or T-Bil more than 3mg/dl) 5) Patients with blood pressure more than 140/90mmHg after PCI. 6) Hematocrit more than 54% after PCI. 7) Patients who exhibit atrial fibrillation after PCI. 8) Patients who has been diagnosed with malignant hypertension. 9) Patients who has previously received treatment with rhEPO. 10) Patients who received a blood transfusion in the last three months. 11) Patients who is or has been diagnosed with cancer in the past 5 years. 12) Patients who are complicated with severe infection such as pneumonia or sepsis. 13) Patients who are contraindicated to aspirin or thienopyridine derivatives. 14)Women who is pregnant, breastfeeding, or has a possibility for pregnancy. 15) Patients whom researchers judged that they are not appropriate to participate this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The improvement of left ventricular ejection fraction at the chronic phase (the mean of differences between LVEF value at 4-7 days and that at 6 months after administration) | — |
Secondary
| Measure | Time frame |
|---|---|
| [Efficacy] 1.Indexes of cardiac function 6 months after administration of epoetin-beta, which are calculated with cardiac scintigraphy. (LVEDV, LVESV, LVEDVI, LVESVI, regional wall motion score, %uptake at resting), and defect size (%Defect Size: SRS (Summed rest Score), SDS (Summed difference Score)) 2.Survival ratio 3.Cardiac event ratio (Cardiac death, stroke, nonlethal myocardial infarction, admission due to worsening of heart failure, revasculization, onset of heart failure symptoms) 4.NT-ProBNP 6 months after administration. [safety] 1.adverse events 2.laboratory test data 3.vital signs (blood pressure, pulse rate) | — |
Countries
Japan
Outcome results
None listed