Pharmacogenomic Informed Statin Prescribing

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorVA Office of Research and Development

About 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 does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Non-Veterans

End-stage renal disease

History of rhabdomyolysis

Active treatment for non-dermatologic cancer

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

410 Participants
are divided into 2 treatment groups
Group A: Genetic testing armExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in low density lipoprotein cholesterol

The primary effectiveness outcome will be the change in LDL-cholesterol level from baseline to 15-months.

Time frame
15-months

Secondary outcomes

Other outcomes

Sponsors and contacts

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