Using genetic testing to improve statin use in Veterans with high cholesterol
Reducing Veterans' Risk of Atherosclerotic Cardiovascular Disease Through Pharmacogenomics Informed Statin Prescribing
This study is trying to see if genetic testing can help Veterans with high cholesterol better understand and stick to their statin medications to lower their risk of heart disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 410 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 2 sites (Indianapolis, Indiana and 1 other locations) |
| Trial ID | NCT06568601 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the acceptance and adherence to statin therapy among Veterans at high risk for cardiovascular disease (CVD) by utilizing pharmacogenomic testing. The approach involves identifying patients who may benefit from statins or are at risk for statin toxicity through genetic testing. By communicating these results to patients, the study seeks to improve their understanding of their CVD risk and the benefits of statin therapy. The ultimate goal is to increase the proportion of patients who accept and adhere to statin treatment, leading to better cholesterol management and reduced cardiovascular risk.
Who should consider this trial
Good fit: Ideal candidates for this study are Veterans aged 40-75 with diabetes or cardiovascular disease who are not currently prescribed statins.
Not a fit: Patients who are non-Veterans or have conditions such as end-stage renal disease or active cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve cholesterol levels and reduce cardiovascular disease risk in high-risk Veterans.
How similar studies have performed: Previous studies have shown that pharmacogenomic testing can effectively improve statin prescribing and patient outcomes, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Indianapolis, Indiana and 1 other locations
- Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis, Indiana, United States (Recruiting)
- Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Deepak Voora, MD — Durham VA Medical Center, Durham, NC
- Study coordinator: Deepak Voora, MD
- Email: deepak.voora@va.gov
- Phone: (919) 286-0411
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.