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CompletedNCT01168622Updated Sep 1, 2023

Impact of Race/Ethnicity on Platelet Function

An observational study in Coronary Heart Disease, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-01.

Sponsored by University of Nebraska · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
625
Ages
19 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

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In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 625 is above the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

University of Nebraska is the lead sponsor of 473 studies on the registry; 66 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
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

Eligibility criteria

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
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
625 participants (estimated)
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Platelet reactivity

    Platelet reactivity as measured by platelet function tests

    Time frame: baseline only

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Study locations

1 site
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01168622
Lead sponsor
University of Nebraska
Responsible party
Sponsor
First posted
Jul 23, 2010
Start date
Jun 1, 2010
Primary completion
Mar 30, 2013
Completion
Mar 30, 2013
Last update
Sep 1, 2023

Study contacts

Julie H Oestreich, PharmD, PhD
principal investigator · University of Nebraska

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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