NCT06568601 Pharmacogenomic Informed Statin Prescribing
| NCT ID | NCT06568601 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Hypercholesterolemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 410 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 410 participants in total. It began in 2025-04-01 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Deepak Voora, MD
PRINCIPAL INVESTIGATOR
Durham VA Medical Center, Durham, NC
Frequently Asked Questions
Who can join the NCT06568601 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Hypercholesterolemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06568601 currently recruiting?
Yes, NCT06568601 is actively recruiting participants. Contact the research team at deepak.voora@va.gov for enrollment information.
Where is the NCT06568601 trial being conducted?
This trial is being conducted at Indianapolis, United States, Durham, United States.
Who is sponsoring the NCT06568601 clinical trial?
NCT06568601 is sponsored by VA Office of Research and Development. The principal investigator is Deepak Voora, MD at Durham VA Medical Center, Durham, NC. The trial plans to enroll 410 participants.