Pharmacogenomic Testing for High Cholesterol
Trial Summary
What is the purpose of this trial?
Statins are the most cost-effective medications to lower cholesterol and cardiovascular disease (CVD) risk. However, many patients at high-risk for CVD do not accept or adhere to statins. This gap in patient's use of statins limits the full impact of these effective medications resulting in higher cholesterol levels and CVD risk. The main barriers to using statins are patients' perceived lack of benefit, excess risk of statin toxicity as well as their misperceptions of their CVD risk. Statin pharmacogenomic testing - an application of precision medicine - is a readily available, feasible, and inexpensive intervention that addresses this barrier by using genetic testing to identify the nearly 1 out of 2 patients with enhanced benefit and/or reduced risk of statin toxicity or increased risk for CVD. By communicating statin pharmacogenomic test results to Veterans at high-risk for CVD not taking statin therapy, the investigators aim to improve patients' perceptions of their risk of CVD and statins and, in turn, their acceptance of and adherence to statins to reduce their cholesterol levels and CVD risk.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must not have an active statin prescription in the past 6 months and cannot be on a PCSK9 inhibitor.
What data supports the effectiveness of the drug Pharmacogenomic Informed Statin Prescribing for high cholesterol?
Is pharmacogenomic testing for high cholesterol safe for humans?
How does the drug Pharmacogenomic Informed Statin Prescribing differ from other treatments for high cholesterol?
Research Team
Dawn M. Bravata, MD
Principal Investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Deepak Voora, MD
Principal Investigator
Durham VA Medical Center, Durham, NC
Eligibility Criteria
This trial is for individuals with high cholesterol who are at risk for cardiovascular disease (CVD) but may be hesitant to take statins due to concerns about their effectiveness or potential side effects. Participants should not currently be on statin therapy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive guideline-based statin recommendations with or without pharmacogenomic test results
Follow-up
Participants are monitored for changes in LDL-cholesterol levels and adherence to statin therapy
Implementation Planning
Development of an implementation blueprint package for dissemination to Veterans and VHA facilities
Treatment Details
Interventions
- Pharmacogenomic Informed Statin Prescribing
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor