Actively Recruiting

Phase Not Applicable
Age: 40Years - 75Years
All Genders
NCT06568601

Pharmacogenomic Informed Statin Prescribing

Led by VA Office of Research and Development · Updated on 2026-04-13

410

Participants Needed

2

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial 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. 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

Official Title

Pharmacogenomic Informed Statin Prescribing

Who Can Participate

Age: 40Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be a Veteran
  • Be between 40 and 75 years old
  • Have diabetes mellitus or cardiovascular disease (coronary, cerebral, or peripheral artery disease)
  • Have an upcoming primary care appointment within the next 4 months
  • Have no active statin prescription in the past 6 months
  • Be able to speak English
  • Have at least one current active VA prescription
  • Have had at least one primary care appointment within the past 2 years
Not Eligible

You will not qualify if you...

  • Not be a Veteran
  • Have end-stage renal disease
  • Have a history of rhabdomyolysis
  • Be receiving active treatment for non-dermatologic cancer
  • Have known prior SLCO1B1 genetic test results
  • Have liver cirrhosis
  • Be receiving palliative care or hospice within the past year or during hospital stay or at discharge
  • Have an active prescription for PCSK9 inhibitor
  • Be unable to provide informed consent due to language impairment, cognitive disease, or similar factors
  • Be actively enrolled in a different interventional clinical trial
  • Have history of allogeneic stem cell transplant or liver transplant
  • Have documented adverse drug reactions attributed to statins such as myopathy with high creatinine kinase, angioedema, elevated AST/ALT, or other reactions at investigator's discretion

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, United States, 46202-2884

Actively Recruiting

2

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States, 27705-3875

Not Yet Recruiting

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Research Team

D

Deepak Voora, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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