REVEAL: Reduction of Infarct Expansion and Ventricular Remodeling With Erythropoietin After Large Myocardial Infarction
NCT ID: NCT00378352
Last Updated: 2017-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
223 participants
INTERVENTIONAL
2005-09-30
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dose Escalation Safety
The objective of the first phase is to evaluate the safety of escalating doses of Epoetin alfa in patients with STEMIs.
Epoetin alfa
Randomized
Single Dose Efficacy
Single parenteral administration of 60000 U of epoetin alfa. The objectives of the second phase are to investigate the effects of the highest safe dose on infarct size, left ventricular remodeling and endothelial progenitor cells.
Epoetin alfa
Randomized
Interventions
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Epoetin alfa
Randomized
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Acute ST-elevation myocardial infarction
Referral for primary or rescue angioplasty
Revascularization procedure within 8 hours from the onset of ischemic symptoms
TIMI (Thrombolysis in myocardial infarction) flow grade 0 or 1 in the culprit coronary artery at the beginning of coronary angiography
Successful revascularization of infarct-related artery
Exclusion Criteria
STEMI (ST-elevation myocardial infarction) due to occlusion of a branch vessel
Any history of prior MI, PCI (Percutaneous coronary intervention), CABG (Coronary artery bypass graft), cardiomyopathy, myocarditis, or CHF (congestive heart failure)
Hypersensitivity to human albumin, mammalian cell-derived products, or erythropoietin
Hematocrit greater than 42% in men or greater than 40% in women at the time of study drug administration
Uncontrolled hypertension at the time of study drug administration
Cardiogenic shock
Need for coronary surgical revascularization as determined at the time of the index coronary catheterization
History of hypercoagulable disorder, thromboembolic event, or venous thrombosis
History of stroke or TIA (transient ischemic attack)
History of seizures
Contraindication to MRI
Pregnancy or nursing mother
21 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Responsible Party
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Principal Investigators
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Edward G Lakatta, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute on Aging (NIA)
Locations
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Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Miami, School of Medicine
Miami, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Henry Ford Hospital
Detroit, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
New York Methodist Hospital
Brooklyn, New York, United States
Cornell University
New York, New York, United States
NY Presbyterian Hospital
New York, New York, United States
Weill Medical College
New York, New York, United States
Duke University
Durham, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Penn State Heart and Vascular Institute
Hershey, Pennsylvania, United States
Nashville Cardiovascular Magnetic Resonance Institute
Brentwood, Tennessee, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Countries
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References
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Bogoyevitch MA. An update on the cardiac effects of erythropoietin cardioprotection by erythropoietin and the lessons learnt from studies in neuroprotection. Cardiovasc Res. 2004 Aug 1;63(2):208-16. doi: 10.1016/j.cardiores.2004.03.017.
Parsa CJ, Matsumoto A, Kim J, Riel RU, Pascal LS, Walton GB, Thompson RB, Petrofski JA, Annex BH, Stamler JS, Koch WJ. A novel protective effect of erythropoietin in the infarcted heart. J Clin Invest. 2003 Oct;112(7):999-1007. doi: 10.1172/JCI18200.
Maiese K, Li F, Chong ZZ. New avenues of exploration for erythropoietin. JAMA. 2005 Jan 5;293(1):90-5. doi: 10.1001/jama.293.1.90.
Povsic TJ, Najjar SS, Prather K, Zhou J, Adams SD, Zavodni KL, Kelly F, Melton LG, Hasselblad V, Heitner JF, Raman SV, Barsness GW, Patel MR, Kim RJ, Lakatta EG, Harrington RA, Rao SV. EPC mobilization after erythropoietin treatment in acute ST-elevation myocardial infarction: the REVEAL EPC substudy. J Thromb Thrombolysis. 2013 Nov;36(4):375-83. doi: 10.1007/s11239-013-0944-6.
Najjar SS, Rao SV, Melloni C, Raman SV, Povsic TJ, Melton L, Barsness GW, Prather K, Heitner JF, Kilaru R, Gruberg L, Hasselblad V, Greenbaum AB, Patel M, Kim RJ, Talan M, Ferrucci L, Longo DL, Lakatta EG, Harrington RA; REVEAL Investigators. Intravenous erythropoietin in patients with ST-segment elevation myocardial infarction: REVEAL: a randomized controlled trial. JAMA. 2011 May 11;305(18):1863-72. doi: 10.1001/jama.2011.592.
Melloni C, Rao SV, Povsic TJ, Melton L, Kim RJ, Kilaru R, Patel MR, Talan M, Ferrucci L, Longo DL, Lakatta EG, Najjar SS, Harrington RA. Design and rationale of the Reduction of Infarct Expansion and Ventricular Remodeling with Erythropoietin after Large Myocardial Infarction (REVEAL) trial. Am Heart J. 2010 Nov;160(5):795-803.e2. doi: 10.1016/j.ahj.2010.09.007.
Other Identifiers
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05-AG-N255
Identifier Type: OTHER
Identifier Source: secondary_id
999905255
Identifier Type: -
Identifier Source: org_study_id
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