Pharmacogenomic Informed Statin Prescribing
Recruiting now · Not applicable
Conditions studied: Hypercholesterolemia
In brief
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.
Key facts
- Study ID
- NCT06568601
- Run by
- VA Office of Research and Development
- People needed
- 410
- Starts
- 2025-04-01
- Expected to finish
- 2028-07-28
- Last updated by the study team
- 2026-04-13
Who can join
Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients will be included in the analysis if they:
- Are a Veteran
- Aged 40-75 years
- Diabetes mellitus or cardiovascular disease (coronary, cerebral, or peripheral artery disease)
- An upcoming primary care appointment in the next 4 months
- No active statin prescription (any time/dose, VA, or non-VA) in the prior 6 months
- English speaking
- At least 1 current active VA prescription
- At least 1 primary care appointment within the prior 2 years
You may not qualify if…
- Non-Veterans
- End-stage renal disease
- History of rhabdomyolysis
- Active treatment for non-dermatologic cancer
- Known, prior SLCO1B1 genetic test results
- Liver cirrhosis
- Palliative care or hospice in 1-year prior to admission, during hospital stay, or at discharge
- Active prescription for PCSK9 inhibitor
- Inability to provide informed consent due to language impairment, cognitive disease, or other similar factors at the discretion of the research assistant or project coordinator.
- Active enrollment in a different, interventional clinical trial, at the discretion of PI.
- History of allogeneic stem cell transplant or liver transplant.
- Documentation of specific adverse drug reactions thought to be attributed to statins:
- Myopathy with associated elevation in creatinine kinase > 10x upper limit of normal
- Angioedema
- Elevated AST/ALT
- Others at discretion of PI
Where it is running
- Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis, Indiana, United States (enrolling)
- Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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