- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01611545
Pharmacogenomics and Effective Treatment With Clopidogrel
June 9, 2015 updated by: Avera McKennan Hospital & University Health Center
Can Pharmacogenomic Testing Improve Response and Avoid Adverse Effects With Clopidogrel Therapy? A Biospecimen Bank for Genetic and Genomic Investigation of Clopidogrel.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
130
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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South Dakota
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Sioux Falls, South Dakota, United States, 57108
- Avera Institute for Human Genetics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Clopidogrel
Patients taking or prescribed clopidogrel or under consideration Utilizing pharmacogenomics to determine the most effective treatment
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Utilizing pharmacogenomics to determine the most effective treatment
Other Names:
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gareth Davies, PhD, Avera McKennan Hospital & University Health Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Simon T, Verstuyft C, Mary-Krause M, Quteineh L, Drouet E, Meneveau N, Steg PG, Ferrieres J, Danchin N, Becquemont L; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) Investigators. Genetic determinants of response to clopidogrel and cardiovascular events. N Engl J Med. 2009 Jan 22;360(4):363-75. doi: 10.1056/NEJMoa0808227. Epub 2008 Dec 22.
- Shuldiner AR, O'Connell JR, Bliden KP, Gandhi A, Ryan K, Horenstein RB, Damcott CM, Pakyz R, Tantry US, Gibson Q, Pollin TI, Post W, Parsa A, Mitchell BD, Faraday N, Herzog W, Gurbel PA. Association of cytochrome P450 2C19 genotype with the antiplatelet effect and clinical efficacy of clopidogrel therapy. JAMA. 2009 Aug 26;302(8):849-57. doi: 10.1001/jama.2009.1232.
- Topol EJ, Schork NJ. Catapulting clopidogrel pharmacogenomics forward. Nat Med. 2011 Jan;17(1):40-1. doi: 10.1038/nm0111-40. No abstract available.
- Mega JL, Hochholzer W, Frelinger AL 3rd, Kluk MJ, Angiolillo DJ, Kereiakes DJ, Isserman S, Rogers WJ, Ruff CT, Contant C, Pencina MJ, Scirica BM, Longtine JA, Michelson AD, Sabatine MS. Dosing clopidogrel based on CYP2C19 genotype and the effect on platelet reactivity in patients with stable cardiovascular disease. JAMA. 2011 Nov 23;306(20):2221-8. doi: 10.1001/jama.2011.1703. Epub 2011 Nov 16.
- Holmes MV, Perel P, Shah T, Hingorani AD, Casas JP. CYP2C19 genotype, clopidogrel metabolism, platelet function, and cardiovascular events: a systematic review and meta-analysis. JAMA. 2011 Dec 28;306(24):2704-14. doi: 10.1001/jama.2011.1880.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
May 31, 2012
First Submitted That Met QC Criteria
June 4, 2012
First Posted (Estimate)
June 5, 2012
Study Record Updates
Last Update Posted (Estimate)
June 11, 2015
Last Update Submitted That Met QC Criteria
June 9, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- AIHG-1410-Clopidogrel
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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