NCT00368238

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. Erythropoietin is made by the kidneys to stimulate red blood cell production to prevent anemia. Platelets are small cells in the blood that help clot blood in case of injury. Platelets also sometimes form blood clots in blood vessels that may cause heart attacks. This study is trying to determine whether erythropoietin increases the clotting action of platelets. Information on erythropoietin in healthy subjects may eventually help in the treatment of patients with heart attacks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2005

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
2 months until next milestone

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
Last Updated

August 24, 2006

Status Verified

August 1, 2006

First QC Date

August 23, 2006

Last Update Submit

August 23, 2006

Conditions

Healthy Subjects

Keywords

Platelet function testsErythropoietinAspirinClopidogrel

Outcome Measures

Primary Outcomes (2)

  • Bleeding time

  • Platelet function assay closure time

Secondary Outcomes (5)

  • Complete Blood Count

  • PT

  • PTT

  • P-selectin

  • von Willebrand factor

Interventions

Recombinant human erythropoietin alfa (drug)DRUG
Aspirin (drug)DRUG
Clopidogrel (drug)DRUG

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 21-40 years
  • Able and willing to provide written informed consent
  • Bleeding time \<10 minutes

You may not qualify if:

  • Any chronic medical disease
  • Chronic or frequent over-the-counter or prescription medication use
  • Hemoglobin \>15 gm/dl for both genders or \<13 gm/dl (men) or \<12 gm/dl (women)
  • Platelet count \>400,000/µl or \<150,000/µl
  • Blood pressure \> 140/90 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Interventions

Pharmaceutical PreparationsAspirinClopidogrel

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Stuart D Katz, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 23, 2006

First Posted

August 24, 2006

Study Start

October 1, 2005

Study Completion

July 1, 2006

Last Updated

August 24, 2006

Record last verified: 2006-08

Locations

US(1)