Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Erythropoietin in Patients With ST-Segment-Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention (REVIVAL-3)
Overview
- Phase
- Phase 3
- Intervention
- Erythropoietin
- Conditions
- Myocardial Infarction
- Sponsor
- Deutsches Herzzentrum Muenchen
- Enrollment
- 138
- Locations
- 2
- Primary Endpoint
- Left ventricular ejection fraction measured by magnetic resonance imaging
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with ST-Segment elevation myocardial infarction \<24 h from pain onset
- •Successful primary PCI and left ventricular ejection fraction \<50%
- •Informed, written consent
- •In women with childbearing potential a pregnancy test is mandatory
Exclusion Criteria
- •Age \< 18 and \> 80 years
- •Cardiogenic shock
- •pericarditis
- •thrombolysis for the index infarction
- •malignancies/other comorbid conditions with life expectancy \< 1 year
- •previous myocardial infarction
- •planned staged PCI or prior PCI within 30 days from index procedure
- •uncontrolled hypertension \>160/100mmHg unresponsive to therapy
- •active bleeding; bleeding diathesis; history of gastrointestinal or genitourinary bleeding, recent trauma or major surgery \< 1 month; history of intracranial bleeding or structural abnormalities; suspected aortic dissection; patient's refusal to blood transfusion
- •hematologic disorders such as essential thrombocytosis, megakaryoblastic leukemia, polycythemia vera
Arms & Interventions
A
recombinant human erythropoietin beta
Intervention: Erythropoietin
B
0.9% NaCl solution
Intervention: Placebo
Outcomes
Primary Outcomes
Left ventricular ejection fraction measured by magnetic resonance imaging
Time Frame: 4-6 months
Secondary Outcomes
- Changes in left ventricular ejection fraction and infarct size(over 6 months)
- Death, recurrent myocardial infarction, IRA-revascularization and stroke(30 days, 6 months)