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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Genetic, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN
RECRUITING
Indianapolis
North Carolina
Durham VA Medical Center, Durham, NC
NOT_YET_RECRUITING
Durham
Contact Information
Primary
Deepak Voora, MD
deepak.voora@va.gov
(919) 286-0411
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2028-07-28
Participants
Target number of participants: 410
Treatments
Experimental: Genetic testing arm
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.
Active_comparator: Control
The control condition involves receipt of a report highlighting the risk of cardiovascular disease and benefits of statins (without genetic test results).
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov