Myocardial Infarction Clinical Trial
Official title:
Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Erythropoietin in Patients With ST-Segment-Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention (REVIVAL-3)
The purpose of this study is to determine whether erythropoietin is superior to placebo with respect to left ventricular ejection fraction in patients with ST-elevation myocardial infarction undergoing percutaneous coronary intervention.
Erythropoietin has lately been shown to exert others than merely hematopoietic functions.
Due to attenuation of cell apoptosis and necrosis and/or enhancing neovascularisation,
erythropoietin could be protective after myocardial ischemia and reperfusion and lead to
infarct size reduction and improvement in left ventricular function. In a controlled
clinical trial, short-term administration of erythropoietin in patients with ischemic stroke
was associated with a significantly better functional recovery, with a lower level of
circulating damage markers and a strong trend to smaller infarct sizes measured by magnetic
resonance imaging. While leaving hematocrit and platelet counts unchanged, short-term
administration of erythropoietin was shown to be safe and very well tolerated (no side
effects reported or observed). The protective effects of short-term erythropoietin in acute
ischemic brain damage are further evaluated in an ongoing multi-center trial in Germany.
Considering the preclinical and clinical data erythropoietin is an attractive candidate to
be evaluated in patients with acute myocardial infarction. In a pilot trial enrolling 22
patients with acute myocardial infarction short-term administration of erythropoietin was
shown to be safe and to significantly increase the level of endothelial progenitor cells
after percutaneous coronary intervention. However, the very small population did not allow
evaluating the benefit in left ventricular function or clinical outcomes.
The aim of the REVIVAL-3 study is to investigate whether there is additional benefit of
short-term administration of erythropoietin in patients with acute myocardial infarction
after successful primary percutaneous coronary intervention (PCI) in terms of left
ventricular ejection fraction.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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