NCT06568601 · VA Office of Research and Development
Pharmacogenomic Informed Statin Prescribing
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- Elevated AST/ALT
- Others at discretion of PI
Where
- Indianapolis, Indiana
- Durham, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations