Pharmacogenomic Informed Statin Prescribing
Reducing Veterans' Risk of Atherosclerotic Cardiovascular Disease Through Pharmacogenomics Informed Statin Prescribing
2 other identifiers
interventional
410
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2024
CompletedFirst Posted
Study publicly available on registry
August 23, 2024
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 28, 2028
April 13, 2026
April 1, 2026
2.2 years
August 21, 2024
April 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in low density lipoprotein cholesterol
The primary effectiveness outcome will be the change in LDL-cholesterol level from baseline to 15-months.
15-months
Study Arms (2)
Genetic testing arm
EXPERIMENTALThe 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.
Control
ACTIVE COMPARATORThe control condition involves receipt of a report highlighting the risk of cardiovascular disease and benefits of statins (without genetic test results).
Interventions
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.
The control condition involves receipt of a report highlighting the risk of cardiovascular disease and benefits of statins (without genetic test
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884, United States
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deepak Voora, MD
Durham VA Medical Center, Durham, NC
- PRINCIPAL INVESTIGATOR
Dawn M. Bravata, MD
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2024
First Posted
August 23, 2024
Study Start
April 1, 2025
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
July 28, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share