Status:
RECRUITING
Pharmacogenomic Informed Statin Prescribing
Lead Sponsor:
VA Office of Research and Development
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Background: Despite the proven efficacy and safety of statins, nearly 250,000 Veterans at high-risk for cardiovascular disease (CVD) seen annually in primary care are not taking them leading to higher...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 28 2028
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT06568601
Start Date
April 1 2025
End Date
July 28 2028
Last Update
April 8 2025
Active Locations (2)
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1
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
2
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705-3875