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Completed

NCT Number: NCT03174990

Aspirin and Thienopyridine Resistance in Peripheral Arterial Disease

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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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Clopidogrel, Poor Metabolism of Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UC Davis Medical Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Primary outcomes

  1. Clopidogrel non-responsiveness

    Time frame: Immediate

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

  2. Aspirin non-responsiveness

    Time frame: Immediate

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

  3. Composite of major adverse cardiovascular events

    Time frame: 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.

Secondary outcomes

  1. Genetic predictors of aspirin and clopidogrel non-responsiveness

    Time frame: Immediate

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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

The Effect of Aspirin and Thienopyridine Non-responsiveness on Outcomes in Peripheral Arterial Disease

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 5, 2017
Registry last updated
Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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