drugset / Trial / NCT00648089

EPOMI Study: ErythroPOietin in Myocardial Infarction

NCT00648089 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

EPOMI is a randomized, open-label, parallel phase II clinical study that will evaluate the effects of a single erythropoietin administration on infarct size and cardiac remodeling in patients with acute myocardial infarction. Eligible patients will be randomly assigned to receive conventional therapy and single infusion of 1000U/kg of epoetin beta or conventional therapy alone. Infarct size and cardiac remodeling parameters will be assessed by cardiac magnetic resonance imaging (MRI) within 3-7 days of the randomization and repeated 3 months later.

Timeline

Start
2008-04
Primary completion
2010-12
Completion
2010-12

Outcome

Missed primary endpoint

paper Single high-dose EPO administered immediately after successful reperfusion in patients with STEMI did not reduce infarct size at 3-month follow-up. PMID 22305837 ↗

paper After 3 months, median infarct size (interquartile range) was 17.5 g (7.6-26.1 g) in the EPO group and 16.0 g (9.4-28.2 g) in the control group (P = .64); PMID 22305837 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject EPO Unknown 1000 iu/kg Intravenous

Indications