Trials / Completed
CompletedNCT00378352
REVEAL: Reduction of Infarct Expansion and Ventricular Remodeling With Erythropoietin After Large Myocardial Infarction
Effects of Erythropoietin on Infarct Size and Left Ventricular Remodeling in Survivors of Large Myocardial Infarctions
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 223 (actual)
- Sponsor
- National Institute on Aging (NIA) · NIH
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Epoetin alfa | Randomized |
Timeline
- Start date
- 2005-09-01
- Primary completion
- 2009-07-01
- Completion
- 2011-01-01
- First posted
- 2006-09-20
- Last updated
- 2017-05-09
- Results posted
- 2017-05-09
Locations
16 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00378352. Inclusion in this directory is not an endorsement.