SNPMiner Trials (Home Page)
Report for Clinical Trial NCT02871934
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
Clinical Safety and Efficacy of Pharmacogenetics in Veteran Care
This study will determine whether using a genetic test (for the SLCO1B1 gene) can help patients and providers choose the right type and dose of cholesterol-lowering statin medications to lower the risk of cardiovascular disease, while minimizing the muscle pain side effects that sometimes occur with statins.
NCT02871934 Cardiovascular Disease MeSH:Cardiovascular Diseases
HPO:Abnormality of the cardiovascular system
1 Interventions
Name: SLCO1B1 Genotype
Description: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
Type: Genetic
Group Labels: 2 PGx+ PGx-
Primary Outcomes
Description: The primary CVD prevention outcome is change in LDL, defined as LDL at baseline subtracted from the LDL one year after enrollment.
Measure: LDL cholesterol Time: 12 monthsSecondary Outcomes
Description: In 2013, the ACC/AHA endorsed guidelines that recommended prescribing statins of specific intensities (moderate or high) for distinct populations. Using patient characteristics and prescription data, the investigators will generate a 2-level CVD prevention outcome (concordant vs. non-concordant) for each participant, a measure of whether a patient's statin prescription is adequate for his/her level of CVD risk.
Measure: Concordance with American College of Cardiology/American Heart Association (ACC/AHA) guidelines for statin use in CVD prevention Time: 12 monthsDescription: Chart review of all patient notes during the 12 months after enrollment will be used to determine the proportion of patients in each arm who experienced statin-related muscle side effects during the observation period.
Measure: Documentation of statin-related myotoxicity Time: 12 monthsDescription: Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines recommend specific simvastatin doses when a patient's SLCO1B1 genotype is known. The investigators will compare each patient's medication prescriptions one year after enrollment to this guideline to generate a 2-level safety outcome (potentially safe vs. potentially unsafe simvastatin prescription) for each participant.
Measure: Concordance with CPIC guidelines for simvastatin use Time: 12 monthsOther Outcomes
Description: Assessed by phone survey 12 months after enrollment. Consists of 2 items: "Do you agree or disagree with these statements?: "My health in the future will depend on my medicines" and "Medicines do more harm than good."
Measure: Belief in medications Time: 12 monthsDescription: Assessed by phone survey 12 months after enrollment. Whether patient remembers receiving PGx results from provider and, if so, remembers the results and interpretation.
Measure: Recall of genetic results Time: 12 monthsDescription: Assessed by phone survey 12 months after enrollment. Whether patient attributes muscle pains, weakness, or cramps to a statin taken in the prior 12 months.
Measure: Statin-related muscle side effects Time: 12 monthsPurpose: Diagnostic
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 rs4149056
Patients: - Aged 40-75 years - Have no history of statin use - Have received VA care for at least the prior 6 months - Are a patient of an enrolled provider - Meet at least 1 of the following criteria: - cardiovascular disease (CVD) - diabetes - LDL cholesterol value >= 190 mg/dL - 10-year CVD risk of 7.5%, calculated with the ACC/AHA 2013 pooled risk equations Exclusion Criteria: - Patients will be ineligible if they: - Do not meet the inclusion criteria - Pregnant - Incarcerated or institutionalized Cardiovascular Disease Cardiovascular Diseases Variants at rs4149056 in the SLCO1B1 gene are associated with a greater risk of simvastatin-related myopathy.
Despite the growing implementation of SLCO1B1 rs4149056 genotyping in health systems across the United States, there is little randomized controlled trial data on the impact of SLCO1B1 testing on clinical outcomes.
In addition, by enrolling statin-naive patients with a recent cholesterol panel, this trial will capture a moment of clinical decision-making when SLCO1B1 rs4149056 genotype might be most clinically relevant.