Pharmacogenomics and Effective Treatment With Clopidogrel

NCT ID: NCT01611545

Last Updated: 2015-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-01-31

Brief Summary

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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

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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.

Conditions

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Pharmacogenomics and Cardiovascular Events

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Clopidogrel

Patients taking or prescribed clopidogrel or under consideration Utilizing pharmacogenomics to determine the most effective treatment

Pharmacogenomics

Intervention Type GENETIC

Utilizing pharmacogenomics to determine the most effective treatment

Interventions

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Pharmacogenomics

Utilizing pharmacogenomics to determine the most effective treatment

Intervention Type GENETIC

Other Intervention Names

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Plavix

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Avera Heart Hospital of South Dakota

UNKNOWN

Sponsor Role collaborator

North Central Heart Institute

UNKNOWN

Sponsor Role collaborator

Avera McKennan Hospital & University Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gareth Davies, PhD

Role: PRINCIPAL_INVESTIGATOR

Avera McKennan Hospital & University Health Center

Locations

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Avera Institute for Human Genetics

Sioux Falls, South Dakota, United States

Site Status

Countries

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United States

References

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Topol EJ, Schork NJ. Catapulting clopidogrel pharmacogenomics forward. Nat Med. 2011 Jan;17(1):40-1. doi: 10.1038/nm0111-40. No abstract available.

Reference Type BACKGROUND
PMID: 21217678 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22088980 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19706858 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19106083 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22203539 (View on PubMed)

Other Identifiers

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AIHG-1410-Clopidogrel

Identifier Type: -

Identifier Source: org_study_id

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