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Completed

NCT Number: NCT00367991

Effects of Recombinant Human Erythropoietin on Platelet Function in Patients With Acute Myocardial Infarction

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale University

New Haven, Connecticut, 06510, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recombinant human erythropoietin alfa (drug)

Drug

200 U/kg IV daily for 3 days vs. matched volume of normal saline IV daily for 3 days

Placebo

Drug

Normal saline to match active drug (rHuEpo)

Primary outcomes

  1. Bleeding Time

    Time frame: Change from Day 3 to Day 10

    An integrated measure of in vivo platelet function and tissue hemostasis.

  2. Platelet Function Assay Closure Time

    Time frame: Change from Day 3 to Day 10

Secondary outcomes

  1. Left Ventricular Ejection Fraction

    Time frame: Day 1 and Day 10

  2. Serum Markers of Myocyte Damage

    Time frame: Baseline

    Myocyte Damage is represented by Creatine phosphokinase (CPK). CPK is measured in U/L, as scalar measure of the enzyme activity. CPK was measured for clinical indications laboratory.

  3. Circulating Endothelial Progenitor Cells

    Time frame: Day 3 and Day 10

  4. Serum Markers of Apoptosis

    Time frame: Day 1 and Day 10

    Apoptosis is represented by Fas ligand (FasL or CD95L). FasL (CD95L) is measured in pg/mL.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • American Heart Association

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 24, 2006
Registry last updated
Jan 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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