Recruiting

Statin Prescribing

Sponsor:

VA Office of Research and Development

Code:

NCT06568601

Conditions

Hypercholesterolemia

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Pharmacogenetic and polygenic risk testing

Active control

Study Details

Brief 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.

Conditions

Hypercholesterolemia

Study ID

NCT06568601

Start date

Apr 1, 2025

Status verified date

Apr, 2026

Completion date

Jul 28, 2028

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

410 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Genetic testing arm

The intervention involves: genetic testing; interpretation; and prior to and shortly following an upcoming appointment, communication to patients and providers about the patients' predicted statin efficacy and toxicity, genetic risk for CVD, and individualized recommended statin type/dose.

active comparator: Control

The control condition involves receipt of a report highlighting the risk of cardiovascular disease and benefits of statins (without genetic test results).

Interventions

Pharmacogenetic and polygenic risk testing

The intervention involves: genetic testing; interpretation; and prior to and shortly following an upcoming appointment, communication to patients and providers about the patients' predicted statin efficacy and toxicity, genetic risk for CVD, and individualized recommended statin type/dose.

Active control

The control condition involves receipt of a report highlighting the risk of cardiovascular disease and benefits of statins (without genetic test

Primary outcome measure

  • Change in low density lipoprotein cholesterol [ Time Frame: 15-months ]

Central Contacts and Locations

Central contacts

Deepak Voora, MD

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

Locations

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Recruiting

Indianapolis, Indiana, United States, 46202-2884

Contacts

Dawn M Bravata, MD

317-988-2676Dawn.Bravata2@va.gov

Ali E Sexson, BS MBA

ali.sexson@va.gov

Principal Investigator:

Dawn M. Bravata, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Atherosclerosis
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Pharmacogenomic Testing
  • Genetic Risk Score

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-13.