410 Participants Needed

Pharmacogenomic Testing for High Cholesterol

Recruiting at 1 trial location
DV
Overseen ByDeepak Voora, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have an active statin prescription in the past 6 months and cannot be on a PCSK9 inhibitor.

What data supports the effectiveness of the drug Pharmacogenomic Informed Statin Prescribing for high cholesterol?

Research shows that using genetic information to guide statin prescriptions can improve how well these drugs work for lowering cholesterol. By identifying genetic variations, doctors can choose the most effective statin for each patient, potentially leading to better treatment outcomes.12345

Is pharmacogenomic testing for high cholesterol safe for humans?

Pharmacogenomic testing for high cholesterol, particularly with statins, is generally considered safe, but some people may experience muscle-related side effects. Genetic testing can help identify those at risk for these side effects, potentially improving safety.12367

How does the drug Pharmacogenomic Informed Statin Prescribing differ from other treatments for high cholesterol?

Pharmacogenomic Informed Statin Prescribing is unique because it uses genetic testing to tailor statin therapy to individual patients, potentially improving effectiveness and reducing side effects compared to standard statin treatments that do not consider genetic differences.12345

Research Team

DM

Dawn M. Bravata, MD

Principal Investigator

Richard L. Roudebush VA Medical Center, Indianapolis, IN

DV

Deepak Voora, MD

Principal Investigator

Durham VA Medical Center, Durham, NC

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.
See 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.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive guideline-based statin recommendations with or without pharmacogenomic test results

12 months
Regular visits as per primary care schedule

Follow-up

Participants are monitored for changes in LDL-cholesterol levels and adherence to statin therapy

3 months

Implementation Planning

Development of an implementation blueprint package for dissemination to Veterans and VHA facilities

Treatment Details

Interventions

  • Pharmacogenomic Informed Statin Prescribing
Trial OverviewThe 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.
Participant Groups
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).

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

References

Combining familial hypercholesterolemia and statin genetic studies as a strategy for the implementation of pharmacogenomics. A multidisciplinary approach. [2022]
Laboratory Medicine in the Clinical Decision Support for Treatment of Hypercholesterolemia: Pharmacogenetics of Statins. [2019]
Pharmacogenomics of cholesterol-lowering therapy. [2007]
Statin pharmacogenomics: pursuing biomarkers for predicting clinical outcomes. [2021]
Pharmacogenetics of HMG-CoA reductase inhibitors: exploring the potential for genotype-based individualization of coronary heart disease management. [2007]
Pharmacogenomics of lipid-lowering therapies. [2022]
Pharmacogenomics of statin response. [2008]