Aspirin and Thienopyridine Resistance in Peripheral Arterial Disease

NCT03174990 | Completed

• 1 other identifier: 224399
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Clopidogrel, Poor Metabolism of

Keywords

aspirin; clopidogrel; peripheral arterial disease; genetics

Outcome Measures

Primary Outcomes (3)

• Clopidogrel non-responsiveness

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

  Immediate

• Aspirin non-responsiveness

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

  Immediate

• 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 Outcomes (1)

• Genetic predictors of aspirin and clopidogrel non-responsiveness

  Immediate

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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%

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• khung keong, MD

  Cardiovascular interventionalist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff physician

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: June 5, 2017
• Study Start: August 31, 2010
• Primary Completion: May 17, 2013
• Study Completion: December 20, 2013
• Last Updated: June 5, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)