Skip to main content
OpenTrials
Completed

NCT Number: NCT01168622

Impact of Race/Ethnicity on Platelet Function

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Platelet reactivity

    Time frame: baseline only

    Platelet reactivity as measured by platelet function tests

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 23, 2010
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.