Aspirin and Thienopyridine Resistance in Peripheral Arterial Disease

University of California, Davis195 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

195

Conditions

Peripheral Arterial Disease Clopidogrel, Poor Metabolism of

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * patient undergoing PAD (carotid or lower extremity) angiography or intervention * greater than or equal to 18 years of age Exclusion Criteria: * patient unable to take aspirin and thienopyridine for any reason (not excluded if take at least one of either medication) * hematocrit less than or equal to 30% * hematocrit greater than or equal to 52%

Locations (1)

UC Davis Medical Center

Sacramento, California, United States

Outcomes

Primary Outcomes

Clopidogrel non-responsiveness

Clopidogrel non-responsiveness was defined as patients with Plavix reaction units (PRU) ≥ 235

Time frame: Immediate

Aspirin non-responsiveness

Aspirin non-responsiveness was defined as patients with aspirin reaction units (ARU) ≥ 550

Time frame: 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.

Time frame: 1 year

Secondary Outcomes

Genetic predictors of aspirin and clopidogrel non-responsiveness

Single nucleotide polymorphisms (SNP) were correlated to measures of aspirin and clopidogrel non-responsiveness

Time frame: Immediate

Data from ClinicalTrials.gov

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