Efficacy Study of Erythropoietin After Revascularization in Myocardial Infarction (REVIVAL-3)

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deutsches Herzzentrum Muenchen
• Treatments: Epoetin Alfa

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

• 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®)