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Acute ST Elevation Myocardial InfarctionPhase 2NCT00378352

REVEAL: Reduction of Infarct Expansion and Ventricular Remodeling With Erythropoietin After Large Myocardial Infarction

A Phase 2 study testing Epoetin alfa in people with Acute ST Elevation Myocardial Infarction, run by National Institute on Aging (NIA) at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Acute ST Elevation Myocardial Infarction
What is being tested?
Epoetin alfa
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
223 participants
Where
16 sitesUnited States
Study dates
Sep 2005to Jan 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Nashville Cardiovascular Magnetic Resonance Institute

    Brentwood, Tennessee, 37027

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University

    Durham, North Carolina, 27710

  • Penn State Heart and Vascular Institute

    Hershey, Pennsylvania, 17033

  • University of Miami, School of Medicine

    Miami, Florida, 33136

  • Cornell University

    New York, New York, 10021-4872

  • NY Presbyterian Hospital

    New York, New York, 10021

  • Weill Medical College

    New York, New York, 10021

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23298

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073-6769

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Wake Forest University

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Effects of Erythropoietin on Infarct Size and Left Ventricular Remodeling in Survivors of Large Myocardial Infarctions

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

Read the detailed description

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.

Being tested
Epoetin alfa
Keywords
Acute Myocardial Infarction, Left Ventricular Remodeling, Cardiac Magnetic Resonance Imaging, Endothelial Progenitor Cells, Infarct Size
Medical subject headings
Ventricular Remodeling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epoetin alfaDrug

    Also called PROCRIT

    Randomized

Study groups in NCT00378352
Study groupRoleWhat they receive
Dose Escalation SafetyPlacebo comparatorThe objective of the first phase is to evaluate the safety of escalating doses of Epoetin alfa in patients with STEMIs.
Receives: Drug: Epoetin alfa
Single Dose EfficacyPlacebo comparatorSingle 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.
Receives: Drug: Epoetin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: performed 2 to 6 days after study medication administration (first CMR)

Secondary outcomes (8)

  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.

    Measured: 12 ± 2 weeks after study medication

  2. LV Ejection Fraction

    Measured: 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)

  3. LV Volume Indexed to BSA

    Measured: 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)

  4. LV Mass Indexed to BSA

    Measured: 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)

  5. Vital Signs

    Measured: baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days

  6. Hemoglobin Levels

    Measured: baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days

  7. Reticulocyte Counts

    Measured: baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days

  8. Number of Participants With Clinical Events

    Measured: from randomization to second CMR

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2006 (estimated)
  2. Study startSep 2005
  3. Primary completionJul 2009
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
223 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00378352
Sponsor's protocol ID
999905255
Other IDs
05-AG-N255
Status last verified
May 2017
First submitted
18 Sep 2006
Last updated
9 May 2017
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 15249178

  • 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.

    PubMed 14523037

  • 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.

    PubMed 15632341

  • 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.

    PubMed 23700090

  • 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.

    PubMed 21558517

  • 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.

    PubMed 21095264

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epoetin alfa in people with Acute ST Elevation Myocardial Infarction, run by National Institute on Aging (NIA) at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infarct Size in the Territory of the Infarct Related Artery (time frame: performed 2 to 6 days after study medication administration (first CMR)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00378352, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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