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Trial record 32 of 407 for:    ASPIRIN AND clopidogrel AND Purinergic Antagonists

Aspirin and Thienopyridine Resistance in Peripheral Arterial Disease

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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

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.

Condition or disease
Peripheral Arterial Disease Clopidogrel, Poor Metabolism of

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.

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Study Type : Observational
Actual Enrollment : 195 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Aspirin and Thienopyridine Non-responsiveness on Outcomes in Peripheral Arterial Disease
Actual Study Start Date : August 31, 2010
Actual Primary Completion Date : May 17, 2013
Actual Study Completion Date : December 20, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Group/Cohort
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



Primary Outcome Measures :
  1. Clopidogrel non-responsiveness [ Time Frame: Immediate ]
    Clopidogrel non-responsiveness was defined as patients with Plavix reaction units (PRU) ≥ 235

  2. Aspirin non-responsiveness [ Time Frame: Immediate ]
    Aspirin non-responsiveness was defined as patients with aspirin reaction units (ARU) ≥ 550

  3. 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.


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174990


Locations
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United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: khung keong, MD Cardiovascular interventionalist

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Responsible Party: Khung Keong Yeo, MD, Staff physician, University of California, Davis
ClinicalTrials.gov Identifier: NCT03174990     History of Changes
Other Study ID Numbers: 224399
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Khung Keong Yeo, MD, University of California, Davis:
aspirin
clopidogrel
peripheral arterial disease
genetics

Additional relevant MeSH terms:
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Aspirin
Clopidogrel
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Neurotransmitter Agents