StrokePhase 1NCT01495845
Implementation of a Personalized Medicine (Pharmacogenomics) Service in a Community Pharmacy
A Phase 1 study testing Pharmacogenomics testing for clopidogrel responsiveness in people with Stroke and Transient Ischemic Attack, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility of pharmacogenomics testing in a community pharmacy using clopidogrel as an example. The investigators hypothesize that this testing is feasible in this setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Transient Ischemic Attack, Myocardial Infarction
- What is being tested?
- Pharmacogenomics testing for clopidogrel responsiveness
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jun 2012
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prescribed clopidogrel (Plavix) by their prescriber
- Aged 18 or older
- Currently on clopidogrel therapy for one of the following indicated uses: post-ACS, Recent PCI with stenting, History of TIA or stroke
Who cannot join
- Are unable to complete study materials (surveys) with or without assistance, including non-English speaking patients
- Are taking clopidogrel for a reason other than stated in inclusion criteria
- Are pregnant or nursing
- Have an allergy to aspirin
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the feasibility of pharmacogenomics testing in a community pharmacy using clopidogrel as an example. The investigators hypothesize that this testing is feasible in this setting.
Read the detailed description
To determine if the study is feasible, we will examine the change in patient perception of pharmacogenomics testing (before and after the study), the percentage of patients interested in this service, the response rate of providers to pharmacist recommendations, the pharmacist time requirement, and reimbursement rate for pharmacist services.
- Conditions
- Stroke, Transient Ischemic Attack, Myocardial Infarction
- Being tested
- Pharmacogenomics testing for clopidogrel responsiveness
- Keywords
- pharmacogenomics, feasibility, community pharmacy, personalized medicine, clopidogrel, Plavix
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenomics testing for clopidogrel responsivenessOther
Also called Personalized medicine, Pharmacogenetics
Patients must come to the pharmacy for all visits. At the 1st visit, the patient will provide consent, a complete list of medications, a complete pre-study questionnaire, a copy of their insurance card, and a buccal swab (collected by the pharmacist). The swab will be sent to the testing facility for genotypic testing of CYP2C19. Upon receipt of the results of the results, the pharmacist will propose an intervention to the prescriber based on the patient's indication for clopidogrel and the identification of certain genetic variations atCYP2C19. All patients will be asked to return to the pharmacy for explanation of the results and implementation of any changes approved by the prescriber and to complete a follow-up questionnaire. After the visit to explain the results of testing, the patient's insurance will be billed electronically for a medication therapy management visit; patients without insurance will not be billed. Patients may opt out of billing to insurance at any time.
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Pharmacogenomics testing in a Community pharmacy
Change in patient perception of testing, reimbursement for pharmacist time, provider acceptance, and amount of pharmacist time required will be measured as part of the provision of this service.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Kerr Drug, Laboratory Corporation of America
- Responsible party
- Sponsor
- Investigators
- Stefanie Ferreri, PharmD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495845
- Sponsor's protocol ID
- 10-1558
- Status last verified
- Jun 2012
- First submitted
- 16 Dec 2011
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Personalized Medicine (Pharmacogenomics) Service in a Community Pharmacy
- ClinicalTrials.gov ID
- NCT01495845
- Acronym / sponsor ID
- 10-1558
- Conditions
- Stroke, Transient Ischemic Attack, Myocardial Infarction
- Keywords
- pharmacogenomics, feasibility, community pharmacy, personalized medicine, clopidogrel, Plavix
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Kerr Drug, Laboratory Corporation of America
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 20 Dec 2011 (estimated)
- 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.
The purpose of this study is to determine the feasibility of pharmacogenomics testing in a community pharmacy using clopidogrel as an example. The investigators hypothesize that this testing is feasible in this setting.
Detailed description
To determine if the study is feasible, we will examine the change in patient perception of pharmacogenomics testing (before and after the study), the percentage of patients interested in this service, the response rate of providers to pharmacist recommendations, the pharmacist time requirement, and reimbursement rate for pharmacist services.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Prescribed clopidogrel (Plavix) by their prescriber
- Aged 18 or older
- Currently on clopidogrel therapy for one of the following indicated uses: post-ACS, Recent PCI with stenting, History of TIA or stroke
Key exclusion criteria (4 listed)
- Are unable to complete study materials (surveys) with or without assistance, including non-English speaking patients
- Are taking clopidogrel for a reason other than stated in inclusion criteria
- Are pregnant or nursing
- Have an allergy to aspirin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogenomics testing for clopidogrel responsivenessAlso: Personalized medicine, PharmacogeneticsPatients must come to the pharmacy for all visits. At the 1st visit, the patient will provide consent, a complete list of medications, a complete pre-study questionnaire, a copy of their insurance card, and a buccal swab (collected by the pharmacist). The swab will be sent to the testing facility for genotypic testing of CYP2C19. Upon receipt of the results of the results, the pharmacist will propose an intervention to the prescriber based on the patient's indication for clopidogrel and the identification of certain genetic variations atCYP2C19. All patients will be asked to return to the pharmacy for explanation of the results and implementation of any changes approved by the prescriber and to complete a follow-up questionnaire. After the visit to explain the results of testing, the patient's insurance will be billed electronically for a medication therapy management visit; patients without insurance will not be billed. Patients may opt out of billing to insurance at any time. | Other | – |
Primary outcome
Feasibility of Pharmacogenomics testing in a Community pharmacy
Time frame: 3 months
Change in patient perception of testing, reimbursement for pharmacist time, provider acceptance, and amount of pharmacist time required will be measured as part of the provision of this service.
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 8 Jun 2012.
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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.
Stefanie Ferreri, PharmD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pharmacogenomics testing for clopidogrel responsiveness in people with Stroke and Transient Ischemic Attack, run by University of North Carolina, Chapel Hill 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 3 inclusion and 4 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 8 Jun 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility of Pharmacogenomics testing in a Community pharmacy (time frame: 3 months). 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 8 Jun 2012.