Impact of Race/Ethnicity on Platelet Function

August 29, 2023 updated by: University of Nebraska
The effects of race/ethnicity on platelet function and response to antiplatelet agents will be assessed using healthy participants and coronary heart disease patients from at least 5 racial/ethnic groups.

Study Overview

Status

Completed

Conditions

Detailed Description

The effects of race/ethnicity on platelet function and response to antiplatelet agents will be assessed using 125 healthy subjects, 250 coronary heart disease patients treated with aspirin, and 250 coronary heart disease patients treated with aspirin and a P2Y12 receptor antagonist, clopidogrel or prasugrel. A minimum of 25 healthy people, 50 people taking only aspirin, and 50 people taking aspirin and clopidogrel/prasugrel will be recruited for at least 5 racial/ethnic groups.

Study Type

Observational

Enrollment (Estimated)

625

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy people and coronary heart disease patients taking aspirin or aspirin and clopidogrel or prasugrel

Description

Inclusion Criteria: Each subject must fulfill the following criteria in order to be included in the study.

  • The subject must be capable of understanding the nature of the study and executing an informed consent document.
  • The subject must be aged 19 years or older.
  • For healthy subjects, the subject must deny taking any medications that affect platelet function for at least 7 days before blood collection.
  • For diseased patients, subjects with documented CAD are eligible to participate if they have been treated with antiplatelet therapy of aspirin (81 to 325 mg/day) with and without clopidogrel (75 mg/day) or another P2Y12 antagonist for at least one month.

Exclusion Criteria: For healthy volunteers, subjects who fulfill one or more of the following criteria will be excluded from the study.

  • taking medications for chronic cardiovascular diseases.
  • illnesses requiring hospitalization or surgery within the last three months.
  • history of drug or alcohol abuse.
  • history of recent anemia or thrombocytopenia.
  • history of excessive bleeding or thrombosis.
  • pregnancy.

For coronary heart disease subjects, subjects who fulfill one or more of the following criteria will be excluded from the study.

  • illnesses requiring hospitalization or surgery within the last one month.
  • history of drug or alcohol abuse.
  • history of recent anemia or thrombocytopenia.
  • pregnancy.
  • recent bleeding diathesis
  • malignancy
  • renal insufficiency
  • liver dysfunction
  • treatment with warfarin or glycoprotein (GP) IIb/IIIa antagonists during the preceding 14 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet reactivity
Time Frame: baseline only
Platelet reactivity as measured by platelet function tests
baseline only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

  • Principal Investigator: Julie H Oestreich, PharmD, PhD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2010

Primary Completion (Actual)

March 30, 2013

Study Completion (Actual)

March 30, 2013

Study Registration Dates

First Submitted

June 25, 2010

First Submitted That Met QC Criteria

July 22, 2010

First Posted (Estimated)

July 23, 2010

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0144-10-EP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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