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

This study has been completed.
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00390832
First received: October 19, 2006
Last updated: December 16, 2010
Last verified: March 2009
  Purpose

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 Intervention Phase
Myocardial Infarction
Angioplasty, Transluminal, Percutaneous Coronary
Drug: Erythropoietin
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Left ventricular ejection fraction measured by magnetic resonance imaging [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in left ventricular ejection fraction and infarct size [ Time Frame: over 6 months ] [ Designated as safety issue: No ]
  • Death, recurrent myocardial infarction, IRA-revascularization and stroke [ Time Frame: 30 days, 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 138
Study Start Date: December 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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®)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390832

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

Publications:

Responsible Party: Prof. A. Schömig, Deutsches Herzzentrum Munich
ClinicalTrials.gov Identifier: NCT00390832     History of Changes
Other Study ID Numbers: GE IDE No. I01106
Study First Received: October 19, 2006
Last Updated: December 16, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Deutsches Herzzentrum Muenchen:
STEMI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014