Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aspirin and Thienopyridine Resistance in Peripheral Arterial Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03174990
Recruitment Status : Completed
First Posted : June 5, 2017
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):
Khung Keong Yeo, MD, University of California, Davis

Tracking Information
First Submitted Date May 25, 2017
First Posted Date June 5, 2017
Last Update Posted Date June 5, 2017
Actual Study Start Date August 31, 2010
Actual Primary Completion Date May 17, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 31, 2017)
  • Clopidogrel non-responsiveness [ Time Frame: Immediate ]
    Clopidogrel non-responsiveness was defined as patients with Plavix reaction units (PRU) ≥ 235
  • Aspirin non-responsiveness [ Time Frame: Immediate ]
    Aspirin non-responsiveness was defined as patients with aspirin reaction units (ARU) ≥ 550
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 31, 2017)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Aspirin and Thienopyridine Resistance in Peripheral Arterial Disease
Official Title The Effect of Aspirin and Thienopyridine Non-responsiveness on Outcomes in Peripheral Arterial Disease
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood
Sampling Method Non-Probability Sample
Study Population Patients enrolled between August 2010 and September 2012, with angiographically documented PAD involving carotid or lower extremity arteries. Patients may have been treated surgically or endovascularly at the discretion of the primary physician.
Condition
  • Peripheral Arterial Disease
  • Clopidogrel, Poor Metabolism of
Intervention Not Provided
Study Groups/Cohorts
  • Aspirin responsive
    The participant is shown to be responsive to platelet activity inhibition by aspirin, as determined by testing with VerifyNow
  • Aspirin non-responsive
    The participant is shown to be non-responsive to platelet activity inhibition by aspirin, as determined by testing with VerifyNow
  • Clopidogrel responsive
    The participant is shown to be responsive to platelet activity inhibition by clopidogrel, as determined by testing with VerifyNow
  • Clopidogrel non-responsive
    The participant is shown to be responsive to platelet activity inhibition by clopidogrel, as determined by testing with VerifyNow
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 31, 2017)
195
Original Actual Enrollment Same as current
Actual Study Completion Date December 20, 2013
Actual Primary Completion Date May 17, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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%
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03174990
Other Study ID Numbers 224399
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Khung Keong Yeo, MD, University of California, Davis
Study Sponsor University of California, Davis
Collaborators Not Provided
Investigators
Principal Investigator: khung keong, MD Cardiovascular interventionalist
PRS Account University of California, Davis
Verification Date May 2017