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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00390832
Recruitment Status : Completed
First Posted : October 20, 2006
Last Update Posted : December 17, 2010
Information provided by:
Deutsches Herzzentrum Muenchen

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Angioplasty, Transluminal, Percutaneous Coronary Drug: Erythropoietin Other: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : December 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: A
recombinant human erythropoietin beta
Drug: Erythropoietin
33.333 IU of recombinant human erythropoietin beta are given at 3 time points (immediately, 24 hours and 48 hours after percutaneous coronary intervention) providing a cumulative dose of 100.000 IU
Other Name: NeoRecormon

Placebo Comparator: B
0.9% NaCl solution
Other: Placebo
Patients will receive placebo immediately, 24 hours and 48 hours after percutaneous coronary intervention.
Other Name: 0.9% NaCl

Primary Outcome Measures :
  1. Left ventricular ejection fraction measured by magnetic resonance imaging [ Time Frame: 4-6 months ]

Secondary Outcome Measures :
  1. Changes in left ventricular ejection fraction and infarct size [ Time Frame: over 6 months ]
  2. Death, recurrent myocardial infarction, IRA-revascularization and stroke [ Time Frame: 30 days, 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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®)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00390832

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Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
1. Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
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Study Chair: Albert Schomig, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Ilka Ott, MD Deutsches Herzzentrum Muenchen

Publications of Results:
Other Publications:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. A. Schömig, Deutsches Herzzentrum Munich Identifier: NCT00390832     History of Changes
Other Study ID Numbers: GE IDE No. I01106
First Posted: October 20, 2006    Key Record Dates
Last Update Posted: December 17, 2010
Last Verified: March 2009
Keywords provided by Deutsches Herzzentrum Muenchen:
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Epoetin Alfa