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This is a genetic and platelet reactivity study of African-American versus Caucasian patients undergoing percutaneous coronary intervention and receiving clopidogrel or prasugrel. The investigators aim is twofold: to describe differences in allele frequencies between African-Americans and Caucasians, and to explore associations of platelet reactivity and genetic polymorphisms in these two groups.
The investigators propose a pharmacogenetic cohort study of 100 African-American versus 100 Caucasian patients presenting with an acute coronary syndrome, receiving clopidogrel or prasugrel and undergoing PCI. The study will have four arms: African-American on clopidogrel; African-American on prasugrel; Caucasian on clopidogrel; and Caucasian on prasugrel. All patients will undergo genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay, at least 6 hours after receiving a thienopyridine loading dose, but before hospital discharge. All patients will be treated with aspirin 325 mg/day as well.
Race determination will be based on a patient's self-report, but patients enrolled in the trial must also report that all four of their grandparents were of the same race as theirs. Other races (Asian, Native American, et al) will be excluded from this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| African-American on clopidogrel |
| ||
| African-American on prasugrel |
| ||
| Caucasian on clopidogrel |
| ||
| Caucasian on prasugrel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay | Other | All patients will undergo genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay, at least 6 hours after receiving a thienopyridine loading dose but before hospital discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of CYP polymorphisms | CYP polymorphisms will be classified by their known effects upon enzyme function, using the consensus star-allele nomenclature. More specifically, patients will be classified as a "poor metabolizer" if they possess at least one CYP allele known to be associated with reduced function of that particular CYP enzyme. Allele frequencies will then be compared between African-american and Caucasian patients. | During hospital stay; average hospital stay is less than 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet reactivity | The secondary exploratory objective is to assess for associations between "poor metabolizer" CYP genotypes and the levels of post-thienopyridine platelet reactivity. | During hospital stay; average hospital stay is less than 48 hours |
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Inclusion Criteria:
Patients age 18 or older, of both genders
Presenting with an ACS, defined as at least two of the following:
Self-reported African-american or Caucasian race
a. all 4 grandparents of same race
No contraindications to prasugrel therapy.
Patient is scheduled for, or has already undergone, PCI.
Exclusion Criteria:
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African-american versus Caucasian patients undergoing percutaneous coronary intervention and receiving clopidogrel or prasugrel.
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| Name | Affiliation | Role |
|---|---|---|
| Ron Waksman, MD | Medstar Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D005838 | Genotype |
| ID | Term |
|---|---|
| D055614 | Genetic Phenomena |
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