Genetically Guided Statin Therapy
Completed · Not applicable
Conditions studied: Hypercholesterolemia, Hydroxy-methylglutaryl-coenzyme A (HMG Co-A) Reductase Inhibitors Adverse Reaction
In brief
The purpose of this study is to examine if using genetics can improve statin adherence in patients who should be taking statins but are not because of prior side effects. This study will assist physicians/providers in making a personalized health care plan for prevention of cardiovascular disease.
Key facts
- Study ID
- NCT01894230
- Run by
- Duke University
- People needed
- 167
- Starts
- 2013-07-01
- Expected to finish
- 2016-04-30
- Last updated by the study team
- 2017-06-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Current patient (defined as seen in the last year) of the Duke Primary Care at Pickett Road, Pickens Family Medicine Center or Travis Air Force Base
- Age greater than or equal to 18 years
- Current non-utilization of statin therapy for either of the following reasons: (a) Prior side effects thought to be attributed by the patient to statin use AND/OR (b) Physician removal of statin due to presumed associated side effects
- No statin use for the past 6 weeks
- Active email account
- Computer access available in order to complete on-line surveys
- Ability to provide informed consent
You may not qualify if…
- Prior rhabdomyolysis, or Creatine Kinase (CK) elevation > 10 times the upper limit of normal with any statin therapy
- Prior unexplained elevation in hepatic enzymes [Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 3 times upper limit of normal] with any statin therapy
- Current daily grapefruit juice usage (on average >1quart/day)
- Expected long term use (longer than 3 months) of the following medications known to interfere with statin metabolism or disposition at time of enrollment until the randomization is complete. However, short-term (<14 days) is allowed for the duration of the study
- Participation in a drug research study in the past 30 days
- Previous use of 4 or more statins
Where it is running
- David Grant US Air Force Medical Center — Travis Air Force Base, California, United States
- Duke University — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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