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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Recombinant human erythropoietin alfa (drug)
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Platelet function tests, Erythropoietin, Myocardial infarction

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Bleeding Time
An integrated measure of in vivo platelet function and tissue hemostasis.
Platelet Function Assay Closure Time

Secondary Outcome Measures

Left Ventricular Ejection Fraction
Serum Markers of Myocyte Damage
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.
Circulating Endothelial Progenitor Cells
Serum Markers of Apoptosis
Apoptosis is represented by Fas ligand (FasL or CD95L). FasL (CD95L) is measured in pg/mL.

Full Information

First Posted
August 23, 2006
Last Updated
December 14, 2017
Sponsor
Yale University
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT00367991
Brief Title
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

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
American Heart Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Platelet function tests, Erythropoietin, Myocardial infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
recombinant human erythropoietin 200 U/kg IV daily for 3 days
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Normal saline volume to match active treatment IV daily for 3 days
Intervention Type
Drug
Intervention Name(s)
Recombinant human erythropoietin alfa (drug)
Intervention Description
200 U/kg IV daily for 3 days vs. matched volume of normal saline IV daily for 3 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal saline to match active drug (rHuEpo)
Primary Outcome Measure Information:
Title
Bleeding Time
Description
An integrated measure of in vivo platelet function and tissue hemostasis.
Time Frame
Change from Day 3 to Day 10
Title
Platelet Function Assay Closure Time
Time Frame
Change from Day 3 to Day 10
Secondary Outcome Measure Information:
Title
Left Ventricular Ejection Fraction
Time Frame
Day 1 and Day 10
Title
Serum Markers of Myocyte Damage
Description
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.
Time Frame
Baseline
Title
Circulating Endothelial Progenitor Cells
Time Frame
Day 3 and Day 10
Title
Serum Markers of Apoptosis
Description
Apoptosis is represented by Fas ligand (FasL or CD95L). FasL (CD95L) is measured in pg/mL.
Time Frame
Day 1 and Day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart D Katz, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19958860
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.
Results Reference
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Effects of Recombinant Human Erythropoietin on Platelet Function in Patients With Acute Myocardial Infarction

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