Peripheral Arterial Disease Clinical Trial
Official title:
The Effect of Aspirin and Thienopyridine Non-responsiveness on Outcomes in Peripheral Arterial Disease
Verified date | May 2017 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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% |
Country | Name | City | State |
---|---|---|---|
United States | UC Davis Medical Center | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
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 |
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