Clinical trial NCT00367991: Effects of Recombinant Human Erythropoietin on Platelet Function in Patients With Acute Myocardial Infarction
Official title: Effects of Recombinant Human Erythropoietin on Platelet Function in Patients With Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Infarction
Keywords: Platelet function tests
Erythropoietin
Myocardial infarction
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2006-08-24
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Anti-apoptotic effects of erythropoietin in experimental myocardial infarction (MI) and ischemia-reperfusion injury suggest potential for therapeutic benefit in patients with acute MI. Before the therapeutic potential of recombinant human erythropoietin (rHuEpo) in acute MI can be tested in large clinical trials, more information on the effects of short-term rHuEpo on platelet function are needed. Accordingly, the current proposal aims to determine the effects of rHuEpo (at a dose previously shown not to inhibit the anti-platelet effects of aspirin and clopidogrel in healthy subjects) on platelet function and other safety measures and measure of infarct size in patients with acute coronary syndromes receiving clinically-indicated standard anti-platelet therapy with aspirin, clopidogrel and glycoprotein Iib-IIIa inhibitors.

Specific Aim 1: To determine the effects of intravenous rHuEpo 400 U/kg daily for 3 days vs. placebo on in vivo and in vitro platelet function in patients with acute MI undergoing percutaneous revascularization.

Specific Aim 2: To obtain pilot data to estimate the effects of administration of rHuEpo 400 U/kg daily for 3 days vs. placebo on biochemical markers of myocardial infarction size and left ventricular ejection fraction in patients with acute MI undergoing percutaneous revascularization

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

Primary outcomes:
measure: Bleeding Time
timeFrame: Change from Day 3 to Day 10
measure: Platelet Function Assay Closure Time
timeFrame: Change from Day 3 to Day 10
Secondary outcomes:
measure: Left Ventricular Ejection Fraction
timeFrame: Day 1 and Day 10
measure: Serum Markers of Myocyte Damage
timeFrame: Baseline
measure: Circulating Endothelial Progenitor Cells
timeFrame: Day 3 and Day 10
measure: Serum Markers of Apoptosis
timeFrame: Day 1 and Day 10
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: NYU Langone Health
name: Stuart D Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tang YD, Hasan F, Giordano FJ, Pfau S, Rinder HM, Katz SD. Effects of recombinant human erythropoietin on platelet activation in acute myocardial infarction: results of a double-blind, placebo-controlled, randomized trial. Am Heart J. 2009 Dec;158(6):941-7. doi: 10.1016/j.ahj.2009.06.032.