Impact of Race/Ethnicity on Platelet Function



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:June 2010
End Date:June 2013

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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.


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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