Efficacy Study of Erythropoietin After Revascularization in Myocardial Infarction (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.
Angioplasty, Transluminal, Percutaneous Coronary
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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)|
- Left ventricular ejection fraction measured by magnetic resonance imaging [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
- Changes in left ventricular ejection fraction and infarct size [ Time Frame: over 6 months ] [ Designated as safety issue: No ]
- Death, recurrent myocardial infarction, IRA-revascularization and stroke [ Time Frame: 30 days, 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2006|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Active Comparator: A
recombinant human erythropoietin beta
33.333 IU of recombinant human erythropoietin beta are given at 3 time points (immediately, 24 hours and 48 hours after percutaneous coronary intervention) providing a cumulative dose of 100.000 IU
Other Name: NeoRecormon
Placebo Comparator: B
0.9% NaCl solution
Patients will receive placebo immediately, 24 hours and 48 hours after percutaneous coronary intervention.
Other Name: 0.9% NaCl
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.
|Deutsches Herzzentrum Muenchen|
|Munich, Germany, 80636|
|1. Medizinische Klinik, Klinikum rechts der Isar|
|Munich, Germany, 81675|
|Study Chair:||Albert Schomig, MD||Deutsches Herzzentrum Muenchen|
|Principal Investigator:||Ilka Ott, MD||Deutsches Herzzentrum Muenchen|