NCT00367991

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

September 13, 2011

Completed
Last Updated

January 12, 2018

Status Verified

December 1, 2017

Enrollment Period

1.3 years

First QC Date

August 23, 2006

Results QC Date

August 9, 2011

Last Update Submit

December 14, 2017

Conditions

Myocardial Infarction

Keywords

Platelet function testsErythropoietinMyocardial infarction

Outcome Measures

Primary Outcomes (2)

  • Bleeding Time

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

    Change from Day 3 to Day 10

  • Platelet Function Assay Closure Time

    Change from Day 3 to Day 10

Secondary Outcomes (4)

  • Left Ventricular Ejection Fraction

    Day 1 and Day 10

  • Serum Markers of Myocyte Damage

    Baseline

  • Circulating Endothelial Progenitor Cells

    Day 3 and Day 10

  • Serum Markers of Apoptosis

    Day 1 and Day 10

Study Arms (2)

A

ACTIVE COMPARATOR

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

Drug: Recombinant human erythropoietin alfa (drug)

B

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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

A
PlaceboDRUG

Normal saline to match active drug (rHuEpo)

B

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

Related 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):941-7. doi: 10.1016/j.ahj.2009.06.032.

    PMID: 19958860RESULT

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Results Point of Contact

Title
Stuart Katz, MD
Organization
New York University School of Medicine
stuart.katz@nyumc.org
212-263-3946

Study Officials

  • Stuart D Katz, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2006

First Posted

August 24, 2006

Study Start

November 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

January 12, 2018

Results First Posted

September 13, 2011

Record last verified: 2017-12

Locations

US(1)