Pharmacogenomic Testing for High Cholesterol

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byDawn M. Bravata, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for individuals with high cholesterol who are at risk for cardiovascular disease (CVD) but may be hesitant to take statins due to concerns about their effectiveness or potential side effects. Participants should not currently be on statin therapy.

Inclusion Criteria

Patients who are Veterans

I have a primary care appointment scheduled within the next 4 months.

I haven't taken statins in the last 6 months.

+5 more

Exclusion Criteria

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

I am currently prescribed a PCSK9 inhibitor medication.

I have liver cirrhosis.

+9 more

Participant Groups

The study tests whether genetic testing can help predict the benefits and risks of taking statins, potentially improving patient acceptance and adherence by personalizing treatment plans based on individual genetic profiles.

2Treatment groups

Experimental Treatment

Active Control

Group I: Genetic testing armExperimental Treatment1 Intervention

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.

Group II: ControlActive Control1 Intervention

The control condition involves receipt of a report highlighting the risk of cardiovascular disease and benefits of statins (without genetic test results).