Status:
COMPLETED
Genetically Guided Statin Therapy
Lead Sponsor:
Duke University
Collaborating Sponsors:
David Grant U.S. Air Force Medical Center
Conditions:
Hypercholesterolemia
Hydroxy-methylglutaryl-coenzyme A (HMG Co-A) Reductase Inhibitors Adverse Reaction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 physic...
Detailed Description
Hydroxy-methylglutaryl-coenzyme A (HMG Co-A) reductase inhibitors ("statins") are commonly prescribed to lower low density lipoprotein cholesterol (LDLc) and to prevent cardiovascular disease (CVD), a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2016
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT01894230
Start Date
July 1 2013
End Date
April 30 2016
Last Update
June 23 2017
Active Locations (2)
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1
David Grant US Air Force Medical Center
Travis Air Force Base, California, United States, 94535
2
Duke University
Durham, North Carolina, United States, 27710