Aspirin and Thienopyridine Resistance in Peripheral Arterial Disease

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03174990

Enrollment

195

Registered

2017-06-05

Start date

2010-08-31

Completion date

2013-12-20

Last updated

2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clopidogrel, Poor Metabolism of, Peripheral Arterial Disease

Keywords

aspirin, clopidogrel, peripheral arterial disease, genetics

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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%

Design outcomes

Primary

Measure	Time frame	Description
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
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.

Secondary

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

Countries

United States

Outcome results