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Trial record 9 of 1105 for:    pharmacogenomics OR pharmacogenetics

Implementation of a Personalized Medicine (Pharmacogenomics) Service in a Community Pharmacy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01495845
Recruitment Status : Completed
First Posted : December 20, 2011
Last Update Posted : June 8, 2012
Kerr Drug
Laboratory Corporation of America
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Transient Ischemic Attack Myocardial Infarction Other: Pharmacogenomics testing for clopidogrel responsiveness Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Implementation of a Personalized Medicine (Pharmacogenomics) Service in a Community Pharmacy
Study Start Date : December 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: Pharmacogenomics testing for clopidogrel responsiveness
    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.
    Other Names:
    • Personalized medicine
    • Pharmacogenetics

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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 identifier (NCT number): NCT01495845

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United States, North Carolina
Kerr Drug
Chapel Hill, North Carolina, United States, 27517
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Kerr Drug
Laboratory Corporation of America
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Principal Investigator: Stefanie Ferreri, PharmD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT01495845     History of Changes
Other Study ID Numbers: 10-1558
First Posted: December 20, 2011    Key Record Dates
Last Update Posted: June 8, 2012
Last Verified: June 2012
Keywords provided by University of North Carolina, Chapel Hill:
community pharmacy
personalized medicine
Additional relevant MeSH terms:
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Ischemic Attack, Transient
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs