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This study evaluates the effects of Aspirin and thienopyridine resistance in relation to clinical cardiovascular outcomes as the genetic predictors of, and outcomes associated with aspirin and thienopyridine resistance in patients with peripheral arterial disease (PAD) currently remain unknown.
Although anti-platelet therapy is a cornerstone of PAD treatment, the investigators know very little about the prevalence, genetic determinants and clinical relevance of aspirin and thienopyridine resistance in PAD patients. The investigators expect to report on the prevalence of, and impact on outcomes from aspirin and/or thienopyridine (eg. clopidogrel) resistance, in patients who undergo peripheral arterial angiography/interventions (including carotid angiography/interventions) and operations. This study will provide important information on the utility of testing for aspirin and thienopyridine resistance and improve understanding of the genetic and pathophysiologic basis of anti-platelet therapy resistance in patients with cardiovascular disease, including PAD. Most importantly, this study will serve as the basis for a subsequent randomized prospective trial of different treatment options in PAD patients with aspirin/thienopyridine resistance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin responsive | The participant is shown to be responsive to platelet activity inhibition by aspirin, as determined by testing with VerifyNow | ||
| Aspirin non-responsive | The participant is shown to be non-responsive to platelet activity inhibition by aspirin, as determined by testing with VerifyNow | ||
| Clopidogrel responsive | The participant is shown to be responsive to platelet activity inhibition by clopidogrel, as determined by testing with VerifyNow | ||
| Clopidogrel non-responsive | The participant is shown to be responsive to platelet activity inhibition by clopidogrel, as determined by testing with VerifyNow |
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| Measure | Description | Time Frame |
|---|---|---|
| Clopidogrel non-responsiveness | Clopidogrel non-responsiveness was defined as patients with Plavix reaction units (PRU) ≥ 235 | Immediate |
| Aspirin non-responsiveness | Aspirin non-responsiveness was defined as patients with aspirin reaction units (ARU) ≥ 550 | Immediate |
| Composite of major adverse cardiovascular events | Composite of major adverse cardiovascular events including all-cause mortality, myocardial infarction, stroke, target vessel revascularization (TVR) and limb loss in patients who underwent extremity intervention. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Genetic predictors of aspirin and clopidogrel non-responsiveness | Single nucleotide polymorphisms (SNP) were correlated to measures of aspirin and clopidogrel non-responsiveness | Immediate |
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Inclusion Criteria:
Exclusion Criteria:
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Patients enrolled between August 2010 and September 2012, with angiographically documented PAD involving carotid or lower extremity arteries. Patients may have been treated surgically or endovascularly at the discretion of the primary physician.
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| Name | Affiliation | Role |
|---|---|---|
| khung keong, MD | Cardiovascular interventionalist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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Blood
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |