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Genetic Influence on Statin Pharmacodynamics

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ClinicalTrials.gov Identifier: NCT01569854
Recruitment Status : Withdrawn (Insufficient recruitment)
First Posted : April 3, 2012
Last Update Posted : September 27, 2016
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Joseph Kitzmiller, Ohio State University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The study intends to investigate whether genetics influence how individuals respond to statins (clinical outcomes and changes in carotid intimal media thickness)

Condition or disease
Hyperlipidemia Hypercholesterolemia Dyslipidemia

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study Investigating Genetic Influences on Clinical Outcomes and Change in Carotid Intimal Thickness in Adults Taking Atorvastatin, Simvastatin, or Lovastatin
Study Start Date : March 2012
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
statin


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. carotid intimal media thickness (CIMT) [ Time Frame: 2 years ]
    CIMT measurements will be performed at baseline (within 3 months of starting statin) and at 6, 12, 18, and 24 months. Change in CIMT is considered a surogate measure of atherosclerotic progression.


Biospecimen Retention:   Samples With DNA
nuclear pellet

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals will be recruited from various hospitals, ancillary clinics, and primary-care offices affiliated with the Ohio State University Medical Center (OSUMC).
Criteria

Inclusion Criteria:

  • recently (within past 3 months) started taking atorvastatin, lovastatin, or simvastatin

Exclusion Criteria:

  • concomitant uses of medications, supplements, or OTCs known to interfere with statin metabolism
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569854


Locations
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Joseph P Kitzmiller, MD PhD Ohio State University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Joseph Kitzmiller, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01569854     History of Changes
Other Study ID Numbers: OSU 2011H0261
K23GM100372 ( U.S. NIH Grant/Contract )
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
 Hyperlipoproteinemias
Lipid Metabolism Disorders
Metabolic Diseases