Pharmacogenomic Informed Statin Prescribing
- Conditions
- Hypercholesterolemia
- Registration Number
- NCT06568601
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 410
Inclusion Criteria:<br><br>Patients will be included in the analysis if they:<br><br> - Are a Veteran<br><br> - Aged 40-75 years<br><br> - Diabetes mellitus or cardiovascular disease (coronary, cerebral, or peripheral<br> artery disease)<br><br> - An upcoming primary care appointment in the next 4 months<br><br> - No active statin prescription (any time/dose, VA, or non-VA) in the prior 6 months<br><br> - English speaking<br><br> - At least 1 current active VA prescription<br><br> - At least 1 primary care appointment within the prior 2 years<br><br>Exclusion Criteria:<br><br> - Non-Veterans<br><br> - End-stage renal disease<br><br> - History of rhabdomyolysis<br><br> - Active treatment for non-dermatologic cancer<br><br> - Known, prior SLCO1B1 genetic test results<br><br> - Liver cirrhosis<br><br> - Palliative care or hospice in 1-year prior to admission, during hospital stay, or at<br> discharge<br><br> - Active prescription for PCSK9 inhibitor<br><br> - Inability to provide informed consent due to language impairment, cognitive disease,<br> or other similar factors at the discretion of the research assistant or project<br> coordinator.<br><br> - Active enrollment in a different, interventional clinical trial, at the discretion<br> of PI.<br><br> - History of allogeneic stem cell transplant or liver transplant.<br><br> - Documentation of specific adverse drug reactions thought to be attributed to<br> statins:<br><br> - Myopathy with associated elevation in creatinine kinase > 10x upper limit of<br> normal<br><br> - Angioedema<br><br> - Elevated AST/ALT<br><br> - Others at discretion of PI
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in low density lipoprotein cholesterol
- Secondary Outcome Measures
Name Time Method