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Trial record 3 of 724 for:    pharmacogenomics OR pharmacogenetics
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Pharmacogenomics and Effective Treatment With Clopidogrel

This study is not yet open for participant recruitment.
Verified May 2012 by Avera McKennan Hospital & University Health Center
Sponsor:
Collaborators:
Avera Heart Hospital of South Dakota
North Central Heart Institute
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier:
NCT01611545
First received: May 31, 2012
Last updated: June 4, 2012
Last verified: May 2012
History of Changes
  Purpose

The aim of this biospecimen repository is to evaluate an individual's genotype, identify the variances, and understand how they relate to treatment with clopidogrel.


Condition Intervention
Pharmacogenomics
 Genetic: Pharmacogenomics

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can Pharmacogenomic Testing Improve Response and Avoid Adverse Effects With Clopidogrel Therapy? A Biospecimen Bank for Genetic and Genomic Investigation of Clopidogrel.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Avera McKennan Hospital & University Health Center:

Biospecimen Retention:   Samples With DNA

blood or buccal samples


Estimated Enrollment: 300
Study Start Date: June 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Clopidogrel
Patients taking or prescribed clopidogrel or under consideration
 Genetic: Pharmacogenomics
Utilizing pharmacogenomics to determine the most effective treatment
Other Name: Plavix

Detailed Description:

The objective of this project is to distinguish genetic profiles that will assist a practitioner in determining the right dose or alternate medication for the patient. In partnership with the genetics team of the Avera Institute for Human Genetics and physicians with the Avera Heart Hospital of South Dakota and North Central Heart Institute, the research team will perform genetic analysis to identify genetic variances.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients of either the Avera Heart Hospital of South Dakota or North Central Heart Institute who have been precribed Clopidogrel or are being considered for treatment with Clopidogrel.

Criteria

Inclusion Criteria:

  • Currently taking or prescribed Clopidogrel or under consideration
  • Acute/interventionPatients of the Avera Heart Hospital
  • Cardiology clinic patients with the Avera Heart Hospital and North Central Heart Institute

Exclusion Criteria:

  • Unable to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611545

Contacts
Contact: Jayden Portice 605-322-3054 jayden.portice@avera.org

Locations
United States, South Dakota
Avera Institute for Human Genetics Not yet recruiting
Sioux Falls, South Dakota, United States, 57108
Contact: Julie Fieldsend, RN     605-322-3072     julie.fieldsend@avera.org    
Principal Investigator: Gareth Davies, PhD            
Sub-Investigator: J. Michael Bacharach, MD            
Sub-Investigator: Michael Hibbard, MD            
Sub-Investigator: Krista Bohlen, PharmD            
Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
Avera Heart Hospital of South Dakota
North Central Heart Institute
Investigators
Principal Investigator: Gareth Davies, PhD Avera McKennan Hospital & University Health Center
  More Information

Additional Information:
Avera Research Institute website  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT01611545     History of Changes
Other Study ID Numbers: AIHG-1410-Clopidogrel
Study First Received: May 31, 2012
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Avera McKennan Hospital & University Health Center:
Pharmacogenomics
Pharmacogenetics
Clopidogrel
Plavix

Additional relevant MeSH terms:
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 May 23, 2013