Status:
COMPLETED
Efficacy Study of Erythropoietin After Revascularization in Myocardial Infarction (REVIVAL-3)
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Conditions:
Myocardial Infarction
Angioplasty, Transluminal, Percutaneous Coronary
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 undergoin...
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...
Eligibility Criteria
Inclusion
- 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
- 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
- epilepsy
- 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
- relevant hematologic deviations: hemoglobin \< 100 g/l or hemoglobin \> 160 g/l platelet count \< 100 x 10\^9 cells/l or platelet count \> 600 x 10\^9 cells/l
- any contraindication to magnetic resonance imaging: electronically, magnetically and mechanically activated implants such as cardiac pacemakers, automatic cardioverter defibrillators, joint prostheses, surgical/vascular clips/ hearing aids, neurostimulators, infusion pumps etc metallic splinters in the eye ferromagnetic haemostatic clips in the central nervous system cochlear implants lead wires or similar wires prosthetic heart valves, if dehiscence is suspected non-ferromagnetic stapedial implants, hemostatic clips
- glomerular filtration rate \< 30 ml/min or serum creatinine \> 30 mg/l or dependence on renal dialysis
- chronic liver disease with GOT \> 5-fold over the normal range
- allergy to erythropoietin/true anaphylaxis after prior exposure to contrast media
- phenylketonuria
- previous enrollment in this trial
- women who are known to be pregnant, who are of childbearing potential and test positive for pregnancy, who have given birth within the last 90 days, who are breastfeeding
- patient's inability to fully cooperate with the study protocol
- other contraindication according to the summary of product characteristics of recombinant human erythropoietin beta (NeoRecormon®)
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00390832
Start Date
December 1 2006
End Date
March 1 2009
Last Update
December 17 2010
Active Locations (2)
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1
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
2
1. Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675