Aspirin and Thienopyridine Resistance in Peripheral Arterial Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

195 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-12-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Arterial Disease Clopidogrel, Poor Metabolism of

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Aspirin responsive

The participant is shown to be responsive to platelet activity inhibition by aspirin, as determined by testing with VerifyNow

No interventions assigned to this group

Aspirin non-responsive

The participant is shown to be non-responsive to platelet activity inhibition by aspirin, as determined by testing with VerifyNow

No interventions assigned to this group

Clopidogrel responsive

The participant is shown to be responsive to platelet activity inhibition by clopidogrel, as determined by testing with VerifyNow

No interventions assigned to this group

Clopidogrel non-responsive

The participant is shown to be responsive to platelet activity inhibition by clopidogrel, as determined by testing with VerifyNow

No interventions assigned to this group

Eligibility Criteria

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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%

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes