Impact of Race/Ethnicity on Platelet Function
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Coronary Heart Disease |
| Study Type: | Observational |
| Study Design: | Time Perspective: Cross-Sectional |
| Official Title: | Impact of Race/Ethnicity on Platelet Function |
- Platelet reactivity as measured by platelet function tests [ Time Frame: Platelet reactivity will be assessed at baseline only. No follow-up will occur ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood or saliva samples will be collected for DNA extraction and genotyping of CYP2C19 and other relevant genes.
| Estimated Enrollment: | 625 |
| Study Start Date: | June 2010 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
Contacts and Locations| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198 | |
| Principal Investigator: | Julie H Oestreich, PharmD, PhD | University of Nebraska |
More Information
No publications provided
| Responsible Party: | Julie Oestreich, Pharm D, PhD, Assistant Professor, University of Nebraska |
| ClinicalTrials.gov Identifier: | NCT01168622 History of Changes |
| Other Study ID Numbers: | 144-10 |
| Study First Received: | June 25, 2010 |
| Last Updated: | March 12, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013