Coronary Heart DiseaseNCT01168622
Impact of Race/Ethnicity on Platelet Function
An observational study of Coronary Heart Disease, run by University of Nebraska at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 625 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2010to 30 Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy people and coronary heart disease patients taking aspirin or aspirin and clopidogrel or prasugrel
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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
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.
- Conditions
- Coronary Heart Disease
- Medical subject headings
- Coronary Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet reactivity
Platelet reactivity as measured by platelet function tests
Measured: baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study start1 Jun 2010
- Primary completion30 Mar 2013
- Study completion30 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 625 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie H Oestreich, PharmD, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168622
- Sponsor's protocol ID
- 0144-10-EP
- Status last verified
- Aug 2023
- First submitted
- 25 Jun 2010
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Race/Ethnicity on Platelet Function
- ClinicalTrials.gov ID
- NCT01168622
- Acronym / sponsor ID
- 0144-10-EP
- Conditions
- Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 625 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Jun 2010 (actual)
- Primary completion
- 30 Mar 2013 (actual)
- Study completion
- 30 Mar 2013 (actual)
- First posted
- 23 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy people and coronary heart disease patients taking aspirin or aspirin and clopidogrel or prasugrel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Platelet reactivity
Time frame: baseline only
Platelet reactivity as measured by platelet function tests
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie H Oestreich, PharmD, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet reactivity (time frame: baseline only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.