Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390832
Status:
COMPLETED
Last Update Posted:
2010-12-17
First Post:
2006-10-19
Brief Title:
Efficacy Study of Erythropoietin After Revascularization in Myocardial Infarction REVIVAL-3
Sponsor:
Deutsches Herzzentrum Muenchen
Organization:
Deutsches Herzzentrum Muenchen
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REVIVAL-3
Brief Summary:
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
Detailed Description:
Erythropoietin has lately been shown to exert others than merely hematopoietic functions Due to attenuation of cell apoptosis and necrosis andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None