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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Pharmacogenetic and polygenic risk testing
GeneticThe 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 interventionThe control condition involves receipt of a report highlighting the risk of cardiovascular disease and benefits of statins (without genetic test
Treatment groups
Trial outcomes
Primary outcomes
Change in low density lipoprotein cholesterol
The primary effectiveness outcome will be the change in LDL-cholesterol level from baseline to 15-months.
Sponsors and contacts
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