Clinical Study to Examine the Effects of Erythropoietin on Left Ventricular Function After Acute Myocardial Infarction

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to establish the effects of a single bolus of EPO, administered within three hours after a primary PCI for a first acute myocardial infarction, on left ventricular function.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborators: Janssen-Cilag Ltd.; The Interuniversity Cardiology Institute of the Netherlands
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

Successful primary PCI (TIMI 2/3) for a first acute myocardial infarction, diagnosed by:

• chest pain suggestive for acute myocardial infarction

• symptom onset < 12 hour before hospital admission, or < 24 hour in case ongoing ischemia

• ECG with ST-T segment elevation > 1 mV in 2 or more leads

• TIMI flow 0/1 before primary PCI on diagnostic coronary angiography;

Exclusion Criteria:

• Hemoglobin levels > 10.6 mmol/L;

• Anticipated additional revascularisation within 4 months;

• Cardiogenic shock;

• Presence of other serious medical conditions

• Pregnancy/breast feeding

• Malignant hypertension

• End stage renal failure (creatinin > 220 micromol/l)

• Previous treatment with rh-EPO

• Blood transfusion <12 weeks prior to randomisation

• Polycythemia vera

• Previous acute myocardial infarction

• Concomitant inflammatory or malignant disease

• Recent trauma or major surgery

• Unwilling to sign informed consent

• Atrial fibrillation