VA Cooperative Studies Program (CSP)

Investigator Access

What's Available

Available Documentation

Contact Charles.Brunette@va.gov for research data information, documentation, and other inquiries

Dates Data are Available

• Start date: Pending completion of study objectives and the establishment of a research data repository
• End date: No end date

Access Criteria

Investigators associated with VA or non-VA nonprofit, academic, or research institutions may submit a data request to Charles.Brunette@va.gov. Investigators may be asked to provide a study proposal, including scientific rationale for data access. Data may be used to achieve the aims outlined in the approved research proposal; for reproducibility of original data analyses; and for individual participant data meta-analysis.

All approved data requests require Institutional Review Board (IRB) and/or VA Research and Development (R&D) Committee approval. Prior to data provisioning, approved data requestors must sign a VA data use and transfer agreement. Approved data requestors must comply with VA data security, privacy, and human subjects research requirements.

Study Characteristics

Objectives

To 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.

Era of Service

All

Population

Statin-naïve VA Boston Healthcare System patients with elevated cardiovascular disease (CVD) risk per 2013 American College of Cardiology/American Heart Association (ACC/ACH) Guidelines for statin therapy (6% Female; 14% Non-white race)

Study Design

Randomized, pragmatic, point-of-care clinical trial

Intervention 

Immediate Results Group: PGx+ 

• Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately

Delayed Results Group: PGx- 

• Patients in the PGx- (control) arm will have their SLCO1B1 results reported to their ordering provider at the end of the study (after 12 months)

Time Period

August 2016 – December 2020

Setting

Local (VA Boston Healthcare System)

N

408 participants

Response Rate

12-month outcome data culled from EHR for all participants; 92% end-of-study survey response rate

Recruitment Method

Providers and patients from 8 sites across the VA Boston Healthcare System were recruited to participate in the I-PICC study. Providers enrolled in the study through the electronic health record (EHR). Patients were notified of the study by letter and consented to participate by telephone. Consenting patients were enrolled into the study at the discretion of their provider, using an extant clinical specimen collected during routine clinical care.

Compensation

None

Data Collected

Primary outcomes

• The primary CVD prevention outcome is change in low-density lipoprotein cholesterol (LDL-C), defined as LDL-C at baseline subtracted from the LDL-C one year after enrollment

Secondary outcomes

• Concordance with ACC/ACH Guidelines for statin use in CVD prevention over a period of 12 months  
• The proportion of patients in each arm who experienced statin-related muscle side effects during the observation period over a period of 12 months 
• Concordance with Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for simvastatin use over a period of 12 months

Other assessments

• Demographics 
• Belief in medications 
• Recall of genetic results 
• Statin-related muscle side effects

Data Collection Methods 

•  Electronic health record
•  Medical chart abstraction
•  Participant telephone survey

Funding Source

VA Clinical Science Research and Development (CSR&D)

Investigators

Principal Investigator: Jason Vassy, MD, MPH, SM

Contact

Project Manager: Charles Brunette, PhD; Charles.Brunette@va.gov 

Selected Publications

Vassy, JL, Gaziano JM, Green RC, Ferguson RE, Advani S, Miller SJ, Chun S, Hage AK, Seo SJ, Majahalme N, MacMullen L, Zimolzak AJ, Brunette CA. Effect of Pharmacogenetic Testing for Statin Myopathy Risk vs Usual Care on Blood Cholesterol: A Randomized Clinical Trial. JAMA Netw Open. 2020 Dec1;3(12):e2027092. Doi: 10.1001/jamanetworkopen.2020.27092.

Brunette CA, Dong OM, Vassy JL, Danowski ME, Alexander N, Antwi AA, Christensen KD. A Cost-Consequence Analysis of Preemptive SLCO1B1 Testing for Statin Myopathy Risk Compared to Usual Care. J Pers Med. 2021 Oct 31;11(11):1123. doi: 10.3390/jpm11111123.

Vassy JL, Brunette CA, Majahalme N, Advani S, MacMullen L, Hau C, Zimolzak AJ, Miller SJ. The Integrating Pharmacogenetics in Clinical Care (I-PICC) Study: Protocol for a point-of-care randomized controlled trial of statin pharmacogenetics in primary care. Contemp Clin Trials. 2018 Dec;75:40-50. doi: 10.1016/j.cct.2018.10.010. Epub 2018 Oct 24.

Brunette CA, Miller SJ, Majahalme N, Hau C, MacMullen L, Advani S, Ludin SA, Zimolzak AJ, Vassy JL. Pragmatic trials in genomic medicine: The Integrating Pharmacogenetics in Clinical Care (I-PICC) Study. Clin Transl Sci. 2019 Dec 6. doi: 10.1111/cts.12723. [Epub ahead of print]

More Information

• Study ClinicalTrials.gov site
• ClinicalTrials.gov Identifier: NCT02871934
• Dimensions for VA summary (Requires an account to access outside the VA network. Dimensions for VA is a database that connects publications, grants, patents, clinical trials, and policy documents)