N/A
N=408
Integrating Pharmacogenetics In Clinical Care
Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT02871934 ↗Enrolled (actual)
408
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: 12-Month Change in LDL Cholesterol — -1.1; -2.2 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SLCO1B1 Genotype (Genetic)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 12-Month Change in LDL Cholesterol |
-1.1; -2.2 | — |
| SECONDARY Number of Participants With an American College of Cardiology/American Heart Association (ACC/AHA) Guideline Concordant Statin Prescription at 12 Months |
12; 14 | — |
| SECONDARY Number of Participants With Chart Review Documented Statin-related Myotoxicity at 12 Months |
2; 3 | — |
| SECONDARY Number of Participants Meeting Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for Safe Simvastatin Prescription at 12 Months |
193; 215 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
Providers:
- All providers in Primary Care and Women's Health at VA Boston Healthcare System will be eligible to participate.
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
Data sourced from ClinicalTrials.gov (NCT02871934). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.