Pharmacogenomic Informed Statin Prescribing

Recruiting

Reducing Veterans' Risk of Atherosclerotic Cardiovascular Disease Through Pharmacogenomics Informed Statin Prescribing

Who can join

Ages 40 to 75 · All sexes

Full eligibility criteria

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

About the study

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.

What is being tested

Pharmacogenetic and polygenic risk testing (genetic)
Active control (other)

Sponsor: VA Office of Research and Development · Participants: 410 · Started: Apr 1, 2025

Contact the study team

Deepak Voora, MD · Phone: (919) 286-0411

Official record on ClinicalTrials.gov — NCT06568601

Locations in the U.S.

Indiana	Richard L. Roudebush VA Medical Center, Indianapolis, IN, Indianapolis
North Carolina	Durham VA Medical Center, Durham, NC, Durham (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.