Genetic Influence on Statin Pharmacodynamics

This study is currently recruiting participants.
Verified February 2014 by Ohio State University
Information provided by (Responsible Party):
Joseph Kitzmiller, Ohio State University Identifier:
First received: March 30, 2012
Last updated: February 7, 2014
Last verified: February 2014

The study intends to investigate whether genetics influence how individuals respond to statins (clinical outcomes and changes in carotid intimal media thickness)


Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • carotid intimal media thickness (CIMT) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 200
Study Start Date: March 2012
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).


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
Please refer to this study by its identifier: NCT01569854

Contact: Joseph P Kitzmiller, MD PhD (614) 292 8438

United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Joseph P Kitzmiller, MD PhD    614-292-8438   
Principal Investigator: Joseph P Kitzmiller, MD PhD         
Sub-Investigator: Bhagwan Satiani, MD         
Sub-Investigator: Michael Go, MD         
Sub-Investigator: Rebecca Jackson, MD         
Sponsors and Collaborators
Ohio State University
Principal Investigator: Joseph P Kitzmiller, MD PhD Ohio State University
  More Information

No publications provided

Responsible Party: Joseph Kitzmiller, Assistant Professor, Ohio State University Identifier: NCT01569854     History of Changes
Other Study ID Numbers: K23-GM1000372-02, K23GM100372
Study First Received: March 30, 2012
Last Updated: February 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases processed this record on April 15, 2014