MedPath

Pharmacogenomic Informed Statin Prescribing

Not Applicable
Not yet recruiting
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

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

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in low density lipoprotein cholesterol
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath