RecruitingNot Applicable

Pharmacogenomic Informed Statin Prescribing

United States410 participantsStarted 2025-04-01

Plain-language summary

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

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Angioedema * Elevated AST/ALT * Others at discretion of PI

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in low density lipoprotein cholesterol

Timeframe: 15-months

Trial details

NCT IDNCT06568601

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2027-05-31

Contact for this trial

Deepak Voora, MD

(919) 286-0411 deepak.voora@va.gov

View on ClinicalTrials.gov More Hypercholesterolemia trials