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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-03-31

Brief Summary

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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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Detailed Description

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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

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

recombinant human erythropoietin 200 U/kg IV daily for 3 days

Group Type ACTIVE_COMPARATOR

Recombinant human erythropoietin alfa (drug)

Intervention Type DRUG

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

B

Normal saline volume to match active treatment IV daily for 3 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Normal saline to match active drug (rHuEpo)

Interventions

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Recombinant human erythropoietin alfa (drug)

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

Intervention Type DRUG

Placebo

Normal saline to match active drug (rHuEpo)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No