Genetic Testing to Guide Statin Use for High-Cholesterol Veterans

Trial details

Who runs it

VA Office of Research and Development

Trial code

NCT06568601

Record updated

2 November 2026

Original 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.Read full original descriptionShow less

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

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.

Inclusion: Patients will be included in the analysis if they:; Are a Veteran; 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: Known, prior SLCO1B1 genetic test results; Palliative care or hospice in 1-year prior to admission, during hospital stay, or at discharge; Active prescription for PCSK9 inhibitor; End-stage renal disease; History of rhabdomyolysis; Active treatment for non-dermatologic cancer; 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; 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 aspartate transferase (AST)/alanine transaminase (ALT); Others at discretion of principal investigator (PI); Non-Veterans; Liver cirrhosis; Active enrollment in a different, interventional clinical trial, at the discretion of PI.

ClinicalTrials.gov NCT06568601