Aspirin and Thienopyridine Resistance in Peripheral Arterial Disease

Completed

• Conditions: Peripheral Arterial Disease; Clopidogrel, Poor Metabolism of

• Registration Number: NCT03174990
• Lead Sponsor: University of California, Davis

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-08-31
• Primary Completion: 2013-05-17
• Study Completion: 2013-12-20
• Status Verified: 2017-05
• Study First Submitted: 2017-05-25
• Study First Submitted QC: 2017-05-31
• Last Update Submitted: 2017-05-31
• Study First Posted: 2017-06-05
• Last Update Posted: 2017-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

• patient undergoing PAD (carotid or lower extremity) angiography or intervention
• greater than or equal to 18 years of age

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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%

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of major adverse cardiovascular events	1 year	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.
Clopidogrel non-responsiveness	Immediate	Clopidogrel non-responsiveness was defined as patients with Plavix reaction units (PRU) ≥ 235
Aspirin non-responsiveness	Immediate	Aspirin non-responsiveness was defined as patients with aspirin reaction units (ARU) ≥ 550

Secondary Outcome Measures

Name	Time	Method
Genetic predictors of aspirin and clopidogrel non-responsiveness	Immediate	Single nucleotide polymorphisms (SNP) were correlated to measures of aspirin and clopidogrel non-responsiveness

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States