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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367991
• Other study ID #: 0506000140
• Secondary ID: 0555844T
• Status: Completed
• Phase: Phase 2
• First received: August 23, 2006
• Last updated: December 14, 2017
• Start date: November 2006
• Est. completion date: March 2008

Study information

• Verified date: December 2017
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Recombinant human erythropoietin alfa (drug)
200 U/kg IV daily for 3 days vs. matched volume of normal saline IV daily for 3 days
• Placebo
Normal saline to match active drug (rHuEpo)

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	American Heart Association

Country where clinical trial is conducted

United States, 

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding Time	An integrated measure of in vivo platelet function and tissue hemostasis.	Change from Day 3 to Day 10
Primary	Platelet Function Assay Closure Time		Change from Day 3 to Day 10
Secondary	Left Ventricular Ejection Fraction		Day 1 and Day 10
Secondary	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.	Baseline
Secondary	Circulating Endothelial Progenitor Cells		Day 3 and Day 10
Secondary	Serum Markers of Apoptosis	Apoptosis is represented by Fas ligand (FasL or CD95L). FasL (CD95L) is measured in pg/mL.	Day 1 and Day 10