NCT06568601Recruiting
Pharmacogenomic Informed Statin Prescribing
Reducing Veterans' Risk of Atherosclerotic Cardiovascular Disease Through Pharmacogenomics Informed Statin Prescribing
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 214 (estimated)
- First submitted
- 21 Aug 2024
- Start date
- 1 Apr 2025
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT06568601
What you commit to
- Study type: Interventional
- Planned participants: 214
- From 1 Apr 2025 to the primary completion date, 31 Oct 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known, prior SLCO1B1 genetic test results
- Palliative care or hospice in 1-year prior to admission, during hospital stay, or at discharge
- Active prescription for PCSK9 inhibitor
Other illness
- End-stage renal disease
- History of rhabdomyolysis
- Active treatment for non-dermatologic cancer
- 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.
- History of allogeneic stem cell transplant or liver transplant.
Lab values
- 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 aspartate transferase (AST)/alanine transaminase (ALT)
- Others at discretion of principal investigator (PI)
Other
- Non-Veterans
- Liver cirrhosis
- Active enrollment in a different, interventional clinical trial, at the discretion of PI.
Who the study is looking for
- Patients will be included in the analysis if they:
- Are a Veteran
- 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
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Durham VA Medical Center, Durham, NC Coordinator of this site? Confirm its status | Durham | United States | Not yet recruiting |
| Richard L. Roudebush VA Medical Center, Indianapolis, IN Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.