RECRUITING

Pharmacogenomic Informed Statin Prescribing

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-01
Study Completion:2028-07-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06568601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Are a Veteran
  2. * Aged 40-75 years
  3. * Diabetes mellitus or cardiovascular disease (coronary, cerebral, or peripheral artery disease)
  4. * An upcoming primary care appointment in the next 4 months
  5. * No active statin prescription (any time/dose, VA, or non-VA) in the prior 6 months
  6. * English speaking
  7. * At least 1 current active VA prescription
  8. * At least 1 primary care appointment within the prior 2 years
  1. * Non-Veterans
  2. * End-stage renal disease
  3. * History of rhabdomyolysis
  4. * Active treatment for non-dermatologic cancer
  5. * Known, prior SLCO1B1 genetic test results
  6. * Liver cirrhosis
  7. * Palliative care or hospice in 1-year prior to admission, during hospital stay, or at discharge
  8. * Active prescription for PCSK9 inhibitor
  9. * 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.
  10. * Active enrollment in a different, interventional clinical trial, at the discretion of PI.
  11. * History of allogeneic stem cell transplant or liver transplant.
  12. * Documentation of specific adverse drug reactions thought to be attributed to statins:
  13. * Myopathy with associated elevation in creatinine kinase \> 10x upper limit of normal
  14. * Angioedema
  15. * Elevated AST/ALT
  16. * Others at discretion of PI

Contacts and Locations

Study Contact

Deepak Voora, MD
CONTACT
(919) 286-0411
deepak.voora@va.gov

Principal Investigator

Deepak Voora, MD
PRINCIPAL_INVESTIGATOR
Durham VA Medical Center, Durham, NC
Dawn M. Bravata, MD
PRINCIPAL_INVESTIGATOR
Richard L. Roudebush VA Medical Center, Indianapolis, IN

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Deepak Voora, MD, PRINCIPAL_INVESTIGATOR, Durham VA Medical Center, Durham, NC
  • Dawn M. Bravata, MD, PRINCIPAL_INVESTIGATOR, Richard L. Roudebush VA Medical Center, Indianapolis, IN

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01
Study Completion Date2028-07-28

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2028-07-28

Terms related to this study

Keywords Provided by Researchers

  • Atherosclerosis
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Pharmacogenomic Testing
  • Genetic Risk Score

Additional Relevant MeSH Terms

  • Hypercholesterolemia