NCT01611545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 11, 2015

Status Verified

June 1, 2015

Enrollment Period

2.6 years

First QC Date

May 31, 2012

Last Update Submit

June 9, 2015

Conditions

Pharmacogenomics and Cardiovascular Events

Keywords

PharmacogenomicsPharmacogeneticsClopidogrelPlavix

Study Arms (1)

Clopidogrel

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

Genetic: Pharmacogenomics

Interventions

PharmacogenomicsGENETIC

Utilizing pharmacogenomics to determine the most effective treatment

Also known as: Plavix
Clopidogrel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avera Institute for Human Genetics

Sioux Falls, South Dakota, 57108, United States

Location

Related Publications (5)

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

    PMID: 21217678BACKGROUND

  • 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.

    PMID: 22088980BACKGROUND

  • 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.

    PMID: 19706858BACKGROUND

  • 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.

    PMID: 19106083BACKGROUND

  • 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.

    PMID: 22203539BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood or buccal samples

MeSH Terms

Interventions

Pharmacogenomic TestingClopidogrel

Intervention Hierarchy (Ancestors)

Genetic TestingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health ServicesTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Gareth Davies, PhD

    Avera McKennan Hospital & University Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2012

First Posted

June 5, 2012

Study Start

June 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

June 11, 2015

Record last verified: 2015-06

Locations

US(1)