Status:
COMPLETED
Impact of Race/Ethnicity on Platelet Function
Lead Sponsor:
University of Nebraska
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
19+ years
Brief 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 gro...
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2013
Estimated Enrollment :
625 Patients enrolled
Trial Details
Trial ID
NCT01168622
Start Date
June 1 2010
End Date
March 30 2013
Last Update
September 1 2023
Active Locations (1)
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1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198