Genetic Influence on Statin Pharmacodynamics

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Ohio State University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joseph Kitzmiller, Ohio State University
ClinicalTrials.gov Identifier:
NCT01569854
First received: March 30, 2012
Last updated: February 7, 2014
Last verified: February 2014

March 30, 2012
February 7, 2014
March 2012
March 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01569854 on ClinicalTrials.gov Archive Site
Not Provided
clinical outcomes [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
cardiovascular events; muscle or liver toxicity
Not Provided
Not Provided
 
Genetic Influence on Statin Pharmacodynamics
An Observational Study Investigating Genetic Influences on Clinical Outcomes and Change in Carotid Intimal Thickness in Adults Taking Atorvastatin, Simvastatin, or Lovastatin

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

nuclear pellet

Non-Probability Sample

Individuals will be recruited from various hospitals, ancillary clinics, and primary-care offices affiliated with the Ohio State University Medical Center (OSUMC).

  • Hyperlipidemia
  • Hypercholesterolemia
  • Dyslipidemia
Not Provided
statin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
March 2022
March 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Joseph P Kitzmiller, MD PhD (614) 292 8438 joseph.kitzmiller@osumc.edu
United States
 
NCT01569854
K23-GM1000372-02, K23GM100372
No
Joseph Kitzmiller, Ohio State University
Ohio State University
National Institute of General Medical Sciences (NIGMS)
Principal Investigator: Joseph P Kitzmiller, MD PhD Ohio State University
Ohio State University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP