Effects of Recombinant Human Erythropoietin on Platelet Function in Patients With Acute Myocardial Infarction
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - 75 |
| Updated: | 1/14/2018 |
| Start Date: | November 2006 |
| End Date: | March 2008 |
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.
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.
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
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
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
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