PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ERYTHROPOIETIN IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION UNDERGOING PERCUTANEOUS CORONARY INTERVENTION.REVIVAL-3 (Regeneration of Vital Myocardium in ST-Segment Elevation Myocardial Infarction by Erythropoietin) - REVIVAL-3

• Conditions: Patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention.; MedDRA version: 8.1Level: LLTClassification code 10000891Term: Acute myocardial infarction

• Registration Number: EUCTR2006-003819-45-DE
• Lead Sponsor: Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-26
• Last Update Posted: 4 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients with ST-segment elevation myocardial infarction < 24h from pain start
2. Successful PCI and left ventricular ejection fraction <50%.
3. Informed, written consent
4. In women with childbearing potential a pregnancy test is obligatory.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Age = 18 years and > 80 years.
2. Cardiogenic shock.
3. Pericarditis.
4. Malignancies/other comorbid conditions conditions with life expectancy < 1 year.
5. Previous myocardial infarction.
6. Planned staged PCI or prior PCI within 30 days from index procedure
7. Uncontrolled hypertension >160/100mmHg unresponsive to therapy
8. Epilepsy.
9. 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; and patient’s
refusal to blood transfusion.
10. Hematologic disorders such as essential thrombocytosis, megakaryoblastic
leukemia, polycythemia vera
11. 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.
12. 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; haemostatic clips
13. Glomerular filtration rate < 30 ml/min or serum creatinine >30 mg/l or
dependence on renal dialysis.
14. Chronic liver disease with GOT > 5-fold over the normal range.
15. Allergy to erythropoietin / true anaphylaxis after prior exposure to contrast media
16. Phenylketonuria
17. Previous enrollment in this trial.
18. 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.
19. Patient’s inability to fully cooperate with the study protocol.
20. Other contraindication according to the summary of product characteristics of
recombinant human erythropoietin beta (NeoRecormon®).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified