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Pharmacogenomic Informed Statin Prescribing for Hypercholesterolemia

This study is looking at how genetic testing can help people with high cholesterol (hypercholesterolemia) better understand and use statin medications. Statins are important for lowering cholesterol and reducing the risk of heart disease. The study will compare two groups: one group will receive genetic testing and information about how statins might work for them, including their risk for side effects and heart disease. The other group will receive general information about heart disease risk and statin benefits, without genetic testing. Researchers will measure changes in 'bad' cholesterol (low-density lipoprotein cholesterol) after 15 months to see if the genetic information helps more people take statins and lower their cholesterol. You may be able to join if you are a Veteran, aged 40-75, have diabetes or heart disease, and are not currently taking a statin.

Study design
This is an interventional study planning to enroll 410 participants. It compares two groups: one receiving genetic testing and personalized information, and another receiving general information.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your low-density lipoprotein cholesterol will be measured at 15 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06568601

Pharmacogenomic Informed Statin Prescribing

Recruiting
NAAges 40–75InterventionalHealth services
VA Office of Research and Development
~410 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Pharmacogenetic and polygenic risk testingActive control

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in low density lipoprotein cholesterol
Measured over 15-months

Conditions

Hypercholesterolemia

Explore related trials

AtherosclerosisDiabetes MellitusHypercholesterolemia

Where it's being run

2 sites across 2 states
Indiana1
North Carolina1

Study leadership

  • Deepak Voora, MD · PRINCIPAL_INVESTIGATOR · Durham VA Medical Center, Durham, NC
  • Dawn M. Bravata, MD · PRINCIPAL_INVESTIGATOR · Richard L. Roudebush VA Medical Center, Indianapolis, IN

Who to contact

Deepak Voora, MD
[email protected]
(919) 286-0411 · ext. 175214
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in low density lipoprotein cholesterol15-months

    The primary effectiveness outcome will be the change in LDL-cholesterol level from baseline to 15-months.