Integrating Pharmacogenetics In Clinical Care

NCT02871934 | Completed Results

• 2 other identifiers: SPLC-006-15SIK2CX001262
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Disease

Keywords

Pharmacogenetics; SLCO1B1 protein, human; OATP1B1 protein, human; Simvastatin; Cardiovascular disease; Cholesterol; Statin-related myotoxicity; Veterans; Point-of-care

Outcome Measures

Primary Outcomes (1)

• 12-Month Change in LDL Cholesterol

  The primary CVD prevention outcome is 12-month change in low-density lipoprotein (LDL) cholesterol, defined as LDL value at 12 months minus LDL value at baseline.

  12 months

Secondary Outcomes (3)

• Number of Participants With an American College of Cardiology/American Heart Association (ACC/AHA) Guideline Concordant Statin Prescription at 12 Months

  12 months

• Number of Participants With Chart Review Documented Statin-related Myotoxicity at 12 Months

  12 months

• Number of Participants Meeting Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for Safe Simvastatin Prescription at 12 Months

  12 months

Other Outcomes (3)

• Participant Response Distributions to Belief in Medications Questionnaire at 12 Months

  12 months

• Number of Participants Recalling Pharmacogenetic Testing at 12 Months

  12 months

• Number of Participants Reporting Statin-related Muscle Side Effects at 12 Months

  12 months

Study Arms (2)

PGx+

EXPERIMENTAL

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

Genetic: SLCO1B1 Genotype

PGx-

EXPERIMENTAL

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

Genetic: SLCO1B1 Genotype

Interventions

SLCO1B1 Genotype GENETIC

Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.

Also known as: SLCO1B1 Pharmacogenetic Test

PGx+; PGx-

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• year CVD risk of 7.5%, calculated with the ACC/AHA 2013 pooled risk equations

You may not qualify if:

• Patients will be ineligible if they:
• Pregnant
• Incarcerated or institutionalized

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

Related Publications (3)

• 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.

  PMID: 30367991 BACKGROUND

• 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 Dec 1;3(12):e2027092. doi: 10.1001/jamanetworkopen.2020.27092.

  PMID: 33270123 RESULT

• 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. 2020 Mar;13(2):381-390. doi: 10.1111/cts.12723. Epub 2019 Dec 18.

  PMID: 31808996 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Jason Vassy
• Organization: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

jvassy@partners.org

857-364-2561

Study Officials

• Jason L Vassy, MD MPH

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 18, 2016
• Study Start: August 1, 2016
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 21, 2022
• Results First Posted: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)