Peripheral Arterial DiseaseNCT03174990
Aspirin and Thienopyridine Resistance in Peripheral Arterial Disease
An observational study of Peripheral Arterial Disease and Clopidogrel, Poor Metabolism of, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease, Clopidogrel, Poor Metabolism of
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2010to 20 Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- patient undergoing PAD (carotid or lower extremity) angiography or intervention
- greater than or equal to 18 years of age
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Official title: The Effect of Aspirin and Thienopyridine Non-responsiveness on Outcomes in Peripheral Arterial Disease
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.
Read the 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.
- Keywords
- aspirin, clopidogrel, peripheral arterial disease, genetics
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clopidogrel non-responsiveness
Clopidogrel non-responsiveness was defined as patients with Plavix reaction units (PRU) ≥ 235
Measured: Immediate
Aspirin non-responsiveness
Aspirin non-responsiveness was defined as patients with aspirin reaction units (ARU) ≥ 550
Measured: 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.
Measured: 1 year
Secondary outcomes (1)
Genetic predictors of aspirin and clopidogrel non-responsiveness
Single nucleotide polymorphisms (SNP) were correlated to measures of aspirin and clopidogrel non-responsiveness
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start31 Aug 2010
- Primary completion17 May 2013
- Study completion20 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khung Keong Yeo, MD, University of California, Davis
- Investigators
- khung keong, MD, Principal investigator, Cardiovascular interventionalist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174990
- Sponsor's protocol ID
- 224399
- Status last verified
- May 2017
- First submitted
- 25 May 2017
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aspirin and Thienopyridine Non-responsiveness on Outcomes in Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT03174990
- Acronym / sponsor ID
- 224399
- Keywords
- aspirin, clopidogrel, peripheral arterial disease, genetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 31 Aug 2010 (actual)
- Primary completion
- 17 May 2013 (actual)
- Study completion
- 20 Dec 2013 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- patient undergoing PAD (carotid or lower extremity) angiography or intervention
- greater than or equal to 18 years of age
Key exclusion criteria (3 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Genetic predictors of aspirin and clopidogrel non-responsiveness
Time frame: Immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
khung keong, MD principal investigator
Cardiovascular interventionalist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Clopidogrel, Poor Metabolism of, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clopidogrel non-responsiveness (time frame: Immediate). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017.