Clinical trial NCT01611545: Pharmacogenomics and Effective Treatment With Clopidogrel
Official title: Can Pharmacogenomic Testing Improve Response and Avoid Adverse Effects With Clopidogrel Therapy? A Biospecimen Bank for Genetic and Genomic Investigation of Clopidogrel.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pharmacogenomics and Cardiovascular Events
Keywords: Pharmacogenomics
Pharmacogenetics
Clopidogrel
Plavix
Lead sponsor: Avera McKennan Hospital & University Health Center
Sponsor class: OTHER
Collaborators: name: Avera Heart Hospital of South Dakota
name: North Central Heart Institute
First posted: 2012-06-05
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Avera Institute for Human Genetics
state: South Dakota
Study officials:
affiliation: Avera McKennan Hospital & University Health Center
name: Gareth Davies, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Topol EJ, Schork NJ. Catapulting clopidogrel pharmacogenomics forward. Nat Med. 2011 Jan;17(1):40-1. doi: 10.1038/nm0111-40. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.