HealthyNCT01307657
Impact of a High-fat Meal on Assessment of Clopidogrel-induced Platelet Inhibition in Healthy Subjects
A study testing high fat meal in people with Healthy, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a high-fat meal affects the ability of platelet function tests to measure platelet inhibition by clopidogrel. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- high fat meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2011to 1 Mar 2012
- Phase
- Interventional
- 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
Who may be able to join
- 19 years of age or older
- healthy subjects
- deny taking medications that affect platelet function for at least 7 days prior to test
Who cannot join
- history of cardiovascular disease
- any risk factors for cardiovascular disease
- surgery in last 3 months
- history of anemia/thrombocytopenia
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
The purpose of this study is to determine whether a high-fat meal affects the ability of platelet function tests to measure platelet inhibition by clopidogrel.
Read the detailed description
The purpose of this study is to determine the influence of a high-fat meal on assessment of clopidogrel-induced platelet inhibition in healthy people using platelet function assays. Twelve healthy adult subjects will be recruited to take part in this research study. After consent is obtained, subjects will be asked to present to the clinical research center after a 12 hour fast. A baseline blood sample will be drawn at 8 am, and subjects will then be administered a 600 mg dose of clopidogrel. At 12 noon, another blood sample will be drawn to evaluate the extent of maximum platelet inhibition in the fasting state. Subjects will then be provided a standardized high-fat meal with an additional blood sample at 2 pm to evaluate the impact of the high-fat on platelet function assessment.
- Conditions
- Healthy
- Being tested
- high fat meal
- Keywords
- clopidogrel, platelet, platelet function test, healthy, Platelet function tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high fat mealOther
Clopidogrel 600 mg loading dose at 8 am and high-fat meal at 12 pm
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel impact on platelet function | Other | Participants will have a baseline blood sample drawn after a 12 hour fast at 8 am, then be administered a 600 mg dose of clopidogrel. At noon, another blood sample will be drawn to evaluate the extent of maximum platelet inhibition in the fasting state. Participants will then be provided a standardized high-fat meal, then an additional blood sample at 2 pm to evaluate the impact of the high-fat on platelet function assessment. Receives: Other: high fat meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet inhibition
platelet inhibition before versus after a high-fat meal (measured by light transmission aggregometry, whole blood aggregometry, flow cytometry, and VerifyNow assay)
Measured: 3 time points over 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
- Study start15 Feb 2011
- Primary completion1 Mar 2012
- Study completion1 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Oestreich, PharmD, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307657
- Sponsor's protocol ID
- 0568-10-FB
- Status last verified
- Aug 2023
- First submitted
- 22 Feb 2011
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Dobesh PP, Urban JF, Shurmur SW, Oestreich JH. Impact of a high-fat meal on assessment of clopidogrel-induced platelet inhibition in healthy subjects. Thromb J. 2015 Jan 23;13(1):3. doi: 10.1186/s12959-014-0033-x. eCollection 2015.
PubMed 25642145
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 a High-fat Meal on Assessment of Clopidogrel-induced Platelet Inhibition in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01307657
- Acronym / sponsor ID
- 0568-10-FB
- Conditions
- Healthy
- Keywords
- clopidogrel, platelet, platelet function test, healthy, Platelet function tests
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 15 Feb 2011 (actual)
- Primary completion
- 1 Mar 2012 (actual)
- Study completion
- 1 Mar 2012 (actual)
- First posted
- 3 Mar 2011 (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 purpose of this study is to determine whether a high-fat meal affects the ability of platelet function tests to measure platelet inhibition by clopidogrel.
Detailed description
The purpose of this study is to determine the influence of a high-fat meal on assessment of clopidogrel-induced platelet inhibition in healthy people using platelet function assays. Twelve healthy adult subjects will be recruited to take part in this research study. After consent is obtained, subjects will be asked to present to the clinical research center after a 12 hour fast. A baseline blood sample will be drawn at 8 am, and subjects will then be administered a 600 mg dose of clopidogrel. At 12 noon, another blood sample will be drawn to evaluate the extent of maximum platelet inhibition in the fasting state. Subjects will then be provided a standardized high-fat meal with an additional blood sample at 2 pm to evaluate the impact of the high-fat on platelet function assessment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel impact on platelet function | Other | Other: high fat mealParticipants will have a baseline blood sample drawn after a 12 hour fast at 8 am, then be administered a 600 mg dose of clopidogrel. At noon, another blood sample will be drawn to evaluate the extent of maximum platelet inhibition in the fasting state. Participants will then be provided a standardized high-fat meal, then an additional blood sample at 2 pm to evaluate the impact of the high-fat on platelet function assessment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19 years of age or older
- healthy subjects
- deny taking medications that affect platelet function for at least 7 days prior to test
Key exclusion criteria (5 listed)
- history of cardiovascular disease
- any risk factors for cardiovascular disease
- surgery in last 3 months
- history of anemia/thrombocytopenia
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high fat mealClopidogrel 600 mg loading dose at 8 am and high-fat meal at 12 pm | Other | Clopidogrel impact on platelet function |
Primary outcome
Platelet inhibition
Time frame: 3 time points over 6 hours
platelet inhibition before versus after a high-fat meal (measured by light transmission aggregometry, whole blood aggregometry, flow cytometry, and VerifyNow assay)
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.
- Derived from this study: PubMed 25642145Dobesh PP, Urban JF, Shurmur SW, Oestreich JH. Impact of a high-fat meal on assessment of clopidogrel-induced platelet inhibition in healthy subjects. Thromb J. 2015 Jan 23;13(1):3. doi: 10.1186/s12959-014-0033-x. eCollection 2015.
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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 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?
A study testing high fat meal in people with Healthy, 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?
The sponsor lists 3 inclusion and 5 exclusion criteria. 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 inhibition (time frame: 3 time points over 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01307657, which also lists 1 linked publication.
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.