Phase 2
N=44
Effects of Recombinant Human Erythropoietin on Platelet Function in Patients With Acute Myocardial Infarction
Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT00367991 ↗Enrolled (actual)
44
Serious AEs
4.6%
Results posted
Sep 2011
Primary outcome: Primary: Bleeding Time — 1020; 1020 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Recombinant human erythropoietin alfa (drug) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bleeding Time |
1020; 1020 | — |
| PRIMARY Platelet Function Assay Closure Time |
251; 281 | — |
| SECONDARY Left Ventricular Ejection Fraction |
— | — |
| SECONDARY Serum Markers of Myocyte Damage |
817; 652 | — |
| SECONDARY Circulating Endothelial Progenitor Cells |
— | — |
| SECONDARY Serum Markers of Apoptosis |
45; 56; 60; 63 | — |
Summary
The purpose of this study is to see if a naturally-occurring hormone called erythropoietin changes the action of platelets in the blood. Patients with heart attacks are treated with medicines to reduce the clotting action of platelets. This study is trying to determine whether erythropoietin alters the clotting action of platelets in patients receiving anti-platelet medicines. It is important to understand the effects of erythropoietin on platelets since preliminary studies in animals suggest that erythropoietin may protect the heart from damage during a heart attack.
Eligibility Criteria
Inclusion Criteria
- Age 21-75 years
- Clinical evidence of acute myocardial infarction (MI) with total or sub-total occlusion on angiogram
- Status post percutaneous revascularization procedure for acute MI with TIMI 3 flow
- Ongoing clinically-indicated treatment with aspirin, thienopyridines
Exclusion Criteria
- Hemodynamic instability/shock or severe congestive heart failure
- Time from onset of chest pain to revascularization procedure > 16 hours
- Use of intravenous thrombolytic agents for treatment of MI
- Known need for additional revascularization procedures
Data sourced from ClinicalTrials.gov (NCT00367991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.