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| ID | Type | Description | Link |
|---|---|---|---|
| 05-AG-N255 | Other Identifier | NIH |
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The purpose of this study is to evaluate whether erythropoietin can help limit the damage to the heart in patients with acute heart attacks.
REVEAL is a randomized, double-blinded, placebo-controlled, parallel phase II clinical study that will evaluate the effects of erythropoietin administration on infarct size, left ventricular remodeling and circulating endothelial progenitor cells in patients with large myocardial infarctions (MI). The study will be conducted in two phases: a dose-escalation safety phase and a single dose efficacy phase. Eligible patients who present to the hospital with an acute ST-elevation MI and who agree to participate in this study will be randomly assigned to receive a single infusion of study medication consisting either of erythropoietin or placebo. The size of the infarction and the dimensions of the heart will be assessed by cardiac magnetic resonance imaging (MRI) within 2-6 days of the infusion of the study medication, and again approximately 3 months later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Safety | Placebo Comparator | The objective of the first phase is to evaluate the safety of escalating doses of Epoetin alfa in patients with STEMIs. |
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| Single Dose Efficacy | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epoetin alfa | Drug | Randomized |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infarct Size in the Territory of the Infarct Related Artery | Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging. | performed 2 to 6 days after study medication administration (first CMR) |
| Measure | Description | Time Frame |
|---|---|---|
| Infarct Size in the Territory of the Infarct Related Artery | Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging. | 12 ± 2 weeks after study medication |
| LV Ejection Fraction |
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Age greater than 21 years
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:
Clinical indication for erythropoietin
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
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| Name | Affiliation | Role |
|---|---|---|
| Edward G Lakatta, M.D. | National Institute on Aging (NIA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| University of Miami, School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15249178 | Background | 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. | |
| 14523037 | Background | 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. |
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Conducted at 28 US sites between October 2006 and February 2010 and included 222 patients with STEMI who underwent successful percutaneous coronary intervention (PCI) as a primary or rescue reperfusion strategy
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Escalation 15,000 Units Epoetin Alfa | |
| FG001 | Dose Escalation 30,000 Units Epoetin Alfa | |
| FG002 | Dose Escalation 60,000 Units Epoetin Alfa |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Dose Escalation 15,000 Units |
|
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| 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR) |
| LV Volume Indexed to BSA | 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR) |
| LV Mass Indexed to BSA | 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR) |
| Vital Signs | baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days |
| Hemoglobin Levels | baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days |
| Reticulocyte Counts | baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days |
| Number of Participants With Clinical Events | from randomization to second CMR |
| Miami |
| Florida |
| 33136 |
| United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073-6769 | United States |
| Mayo Clinic, Rochester | Rochester | Minnesota | 55905 | United States |
| New York Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Cornell University | New York | New York | 10021-4872 | United States |
| NY Presbyterian Hospital | New York | New York | 10021 | United States |
| Weill Medical College | New York | New York | 10021 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27103 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Penn State Heart and Vascular Institute | Hershey | Pennsylvania | 17033 | United States |
| Nashville Cardiovascular Magnetic Resonance Institute | Brentwood | Tennessee | 37027 | United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | United States |
| 15632341 | Background | 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. |
| 23700090 | Background | 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. |
| 21558517 | Result | 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. |
| 21095264 | Derived | 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. |
| FG003 | Dose Escalation Placebo |
| FG004 | Efficacy Phase 60,000 Units Epoetin Alfa | Prospective, randomized, double-blind, placebo-controlled trial Single dose 60000 U of epoetin alfa |
| FG005 | Efficacy Phase Placebo | Single dose placebo |
| Safety Analysis |
|
| COMPLETED |
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| NOT COMPLETED |
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| Dose Escalation 30,000 Units |
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| Dose Escalation 60,000 Units |
|
| Efficacy Phase |
|
One participant was not included
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| ID | Title | Description |
|---|---|---|
| BG000 | Epoetin Alfa | Dose escalation and efficacy phases |
| BG001 | Placebo | Dose escalation and efficacy phases |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Infarct Size in the Territory of the Infarct Related Artery | Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging. | Analysis only performed on subjects who completed the CMR examination | Posted | Mean | Standard Deviation | percentage of LV mass | performed 2 to 6 days after study medication administration (first CMR) |
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| Secondary | Infarct Size in the Territory of the Infarct Related Artery | Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging. | Analysis only performed on subjects who completed the CMR examination | Posted | Mean | Standard Deviation | percentage of LV mass | 12 ± 2 weeks after study medication |
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| Secondary | LV Ejection Fraction | Analysis only performed on subjects who completed this component of the CMR examination | Posted | Mean | Standard Deviation | percent | 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR) |
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| Secondary | LV Volume Indexed to BSA | Analysis only performed on subjects who completed this component of the CMR examination | Posted | Mean | Standard Deviation | ml/m^2 | 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR) |
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| Secondary | LV Mass Indexed to BSA | Analysis only performed on subjects who completed this component of the CMR examination | Posted | Mean | Standard Deviation | g/m^2 | 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR) |
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| Secondary | Vital Signs | Posted | Mean | Standard Deviation | mmHg | baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days |
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| Secondary | Hemoglobin Levels | Posted | Mean | Standard Deviation | g/dL | baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days |
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| Secondary | Reticulocyte Counts | Posted | Mean | Standard Deviation | percentage of red blood cells | baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days |
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| Secondary | Number of Participants With Clinical Events | Posted | Count of Participants | Participants | from randomization to second CMR |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epoetin Alfa | Patients who received active study medication | 25 | 125 | 55 | 125 | ||
| EG001 | Placebo | Patients who received placebo | 10 | 97 | 36 | 97 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stent Thrombosis | Cardiac disorders | Systematic Assessment | Stent thrombosis was acute (7 hours after study medication) in one participants who received 60000 U dose of epoetin alka and subacute (5 days to 14 days)after receiving study medication |
| |
| MI | Cardiac disorders | Systematic Assessment | Recurrent MI as a result of stent thrombosis |
| |
| Renal Failure | Renal and urinary disorders | Systematic Assessment | 90y male 15000 U developed renal failure and subsequently died of heart failure 2 weeks after enrollment |
| |
| Stroke | Cardiac disorders | Systematic Assessment |
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| Death | Cardiac disorders | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Angina unstable | Cardiac disorders | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Atrioventricular block | Cardiac disorders | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
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| Coronary disease | Cardiac disorders | Systematic Assessment |
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| Dressler's syndrome | Cardiac disorders | Systematic Assessment |
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| Intracardiac thrombus | Cardiac disorders | Systematic Assessment |
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| Ventricular fibrillation | Cardiac disorders | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
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| Heparin-induced thrombocytopenia | General disorders | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Septic shock | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Nephropathy toxic | Renal and urinary disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders | Systematic Assessment |
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| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
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| General disorders and administration site conditions | General disorders | Systematic Assessment |
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| Investigations | Investigations | Systematic Assessment |
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| Psychiatric disorders | Psychiatric disorders | Systematic Assessment |
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| Vascular disorders | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward Lakatta, M.D. | National Institute on Aging, NIH | 410-558-8218 | lakattae@grc.nia.nih.gov |
| ID | Term |
|---|---|
| D020257 | Ventricular Remodeling |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068817 | Epoetin Alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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| Greater than or equal to 70 years |
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| Male |
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