NCT00378352

Brief Summary

The purpose of this study is to evaluate whether erythropoietin can help limit the damage to the heart in patients with acute heart attacks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_2

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

May 9, 2017

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

3.8 years

First QC Date

September 18, 2006

Results QC Date

September 30, 2013

Last Update Submit

May 8, 2017

Conditions

Acute ST Elevation Myocardial Infarction

Keywords

Acute Myocardial InfarctionLeft Ventricular RemodelingCardiac Magnetic Resonance ImagingEndothelial Progenitor CellsInfarct Size

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (8)

  • Infarct Size in the Territory of the Infarct Related Artery

    12 ± 2 weeks after study medication

  • LV Ejection Fraction

    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

  • +3 more secondary outcomes

Study Arms (2)

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.

Drug: Epoetin alfa

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.

Drug: Epoetin alfa

Interventions

Epoetin alfaDRUG

Randomized

Also known as: PROCRIT
Dose Escalation SafetySingle Dose Efficacy

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Miami, School of Medicine

Miami, Florida, 33136, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073-6769, United States

Location

Mayo Clinic, Rochester

Rochester, Minnesota, 55905, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Cornell University

New York, New York, 10021-4872, United States

Location

NY Presbyterian Hospital

New York, New York, 10021, United States

Location

Weill Medical College

New York, New York, 10021, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27103, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Penn State Heart and Vascular Institute

Hershey, Pennsylvania, 17033, United States

Location

Nashville Cardiovascular Magnetic Resonance Institute

Brentwood, Tennessee, 37027, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

Related Publications (6)

  • 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.

    PMID: 15249178BACKGROUND

  • 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.

    PMID: 14523037BACKGROUND

  • 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.

    PMID: 15632341BACKGROUND

  • 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.

    PMID: 23700090BACKGROUND

  • 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.

    PMID: 21558517RESULT

  • 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.

    PMID: 21095264DERIVED

MeSH Terms

Conditions

Ventricular Remodeling

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
Edward Lakatta, M.D.
Organization
National Institute on Aging, NIH
lakattae@grc.nia.nih.gov
410-558-8218

Study Officials

  • Edward G Lakatta, M.D.

    National Institute on Aging (NIA)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2006

First Posted

September 20, 2006

Study Start

September 1, 2005

Primary Completion

July 1, 2009

Study Completion

January 1, 2011

Last Updated

May 9, 2017

Results First Posted

May 9, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(16)