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Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects

NCT ID: NCT00368238

Last Updated: 2006-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-07-31

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. 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.

Detailed Description

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Anti-apoptotic effects of erythropoietin in experimental myocardial infarction and ischemia-reperfusion injury suggest potential for therapeutic benefit in patients with acute MI. Before the therapeutic potential of 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 3 doses of rHuEpo (100U/kg, 200U/kg and 400U/kg daily for 3 days) on platelet function and other safety measures in healthy subjects.

Specific Aim: To determine the effects of three ascending doses of rHuEpo vs. placebo on in vivo and in vitro platelet function in healthy subjects treated with aspirin and clopidogrel.

Hypotheses to be tested: 1) 1) Short-term administration of rHuEpo does not alter bleeding time responses to aspirin and clopidogrel when compared with placebo. 2) Short-term administration does not alter in vitro platelet aggregation responses to aspirin and clopidogrel when compared with placebo.

Conditions

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Healthy Subjects

Keywords

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Platelet function tests Erythropoietin Aspirin Clopidogrel

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Recombinant human erythropoietin alfa (drug)

Intervention Type DRUG

Aspirin (drug)

Intervention Type DRUG

Clopidogrel (drug)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Principal Investigators

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Stuart D Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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AHA 0555844T

Identifier Type: -

Identifier Source: secondary_id

0506000139

Identifier Type: -

Identifier Source: org_study_id