Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGINTERVENTIONAL

Pharmacogenomic Informed Statin Prescribing

Reducing Veterans' Risk of Atherosclerotic Cardiovascular Disease Through Pharmacogenomics Informed Statin Prescribing

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: - 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 willing to sign a consent form 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

GENETIC

Pharmacogenetic and polygenic risk testing

The intervention involves: genetic testing; interpretation; and prior to and shortly following an upcoming appointment, communication to patients and providers about the patients' predicted statin efficacy and toxicity, genetic risk for CVD, and individualized recommended statin type/dose.

OTHER

Active control

The control condition involves receipt of a report highlighting the risk of cardiovascular disease and benefits of statins (without genetic test

Locations (2)

Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States