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Genetic test aims to get vets on statins and cut heart risk

NCT ID NCT06568601

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether genetic testing can help veterans at high risk for heart disease start and stick with statin medications. About 410 veterans aged 40-75 with diabetes or heart disease who are not currently taking statins will receive either a genetic report on their statin response and heart risk, or a standard risk report. The goal is to see if personalized genetic information improves cholesterol levels over 15 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pharmacogenetic and polygenic risk testing
What this could lead to
If successful, this approach could help more veterans lower their cholesterol and reduce heart disease risk by personalizing statin therapy.
What could go wrong
This is a relatively small, early-stage study (410 participants) and focuses on behavior change, not a new drug. Results may not apply to non-veterans or those already on statins.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 410 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atherosclerosis cardiovascular disorder diabetes mellitus Genetic Risk Score Hypercholesterolemia hyperlipidemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypercholesterolemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Durham VA Medical Center, Durham, NC

    NOT_YET_RECRUITING

    Durham, North Carolina, 27705-3875, United States

  • Richard L. Roudebush VA Medical Center, Indianapolis, IN

    RECRUITING

    Indianapolis, Indiana, 46202-2884, United States

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