Trial record 2 of 767 for:    pharmacogenomics OR pharmacogenetics

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

This study has been completed.
Sponsor:
Collaborators:
Kerr Drug
Laboratory Corporation of America
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01495845
First received: December 16, 2011
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Stroke
Transient Ischemic Attack
Myocardial Infarction
Other: Pharmacogenomics testing for clopidogrel responsiveness
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Implementation of a Personalized Medicine (Pharmacogenomics) Service in a Community Pharmacy

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Feasibility of Pharmacogenomics testing in a Community pharmacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 48
Study Start Date: December 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01495845

Locations
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
Investigators
Principal Investigator: Stefanie Ferreri, PharmD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01495845     History of Changes
Other Study ID Numbers: 10-1558
Study First Received: December 16, 2011
Last Updated: June 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
pharmacogenomics
feasibility
community pharmacy
personalized medicine
clopidogrel
Plavix

Additional relevant MeSH terms:
Ischemic Attack, Transient
Infarction
Myocardial Infarction
Stroke
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 27, 2014