Pharmacogenomic Informed Statin Prescribing

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
VA Office of Research and Development
Study ID
NCT06568601
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Pharmacogenetic and polygenic risk testing — GENETIC
    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 control — OTHER
    The control condition involves receipt of a report highlighting the risk of cardiovascular disease and benefits of statins (without genetic test

Study Details

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.

Key Dates

Start date
Apr 1, 2025
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
Jul 28, 2028

Study Design

Enrollment
410 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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).

Primary Outcome Measure

Change in low density lipoprotein cholesterol [ Time Frame: 15-months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Richard L. Roudebush VA Medical Center, Indianapolis, INIndianapolisIndiana46202-2884
Dawn M Bravata, MD
[email protected]
317-988-2676
Ali E Sexson, BS MBA
[email protected]
Dawn M. Bravata, MD (PRINCIPAL_INVESTIGATOR)
Durham VA Medical Center, Durham, NCDurhamNorth Carolina27705-3875
Deepak Voora, MD
[email protected]
919-286-0411
Deepak Voora, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Richard L. Roudebush VA Medical Center, Indianapolis, IN· Indianapolis, INDurham VA Medical Center, Durham, NC· Durham, NC

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