Aspirin and Thienopyridine Resistance in Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174990
• Other study ID #: 224399
• Status: Completed
• Phase: N/A
• First received: May 25, 2017
• Last updated: May 31, 2017
• Start date: August 31, 2010
• Est. completion date: December 20, 2013

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: December 20, 2013
• Est. primary completion date: May 17, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Clopidogrel, Poor Metabolism of
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clopidogrel non-responsiveness	Clopidogrel non-responsiveness was defined as patients with Plavix reaction units (PRU) = 235	Immediate
Primary	Aspirin non-responsiveness	Aspirin non-responsiveness was defined as patients with aspirin reaction units (ARU) = 550	Immediate
Primary	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.	1 year
Secondary	Genetic predictors of aspirin and clopidogrel non-responsiveness	Single nucleotide polymorphisms (SNP) were correlated to measures of aspirin and clopidogrel non-responsiveness	Immediate