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Integrating Pharmacogenetics In Clinical Care (I-PICC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02871934
Recruitment Status : Completed
First Posted : August 18, 2016
Results First Posted : February 21, 2022
Last Update Posted : February 21, 2022
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Genetic: SLCO1B1 Genotype Not Applicable

Detailed Description:

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. The IPICC Study will use a randomized design to determine the impact of the clinical integration of SLCO1B1 genotype testing on important patient outcomes, including statin prescribing, LDL cholesterol, and statin-related myopathy. 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. This randomized-control trial has two primary aims:

Aim 1 (Drug safety): To determine the impact of SLCO1B1 pharmacogenetic testing on concordance with Clinical Pharmacogenetics Implementation Consortium (CPIC) pharmacogenetic guidelines for safe simvastatin prescribing and on the incidence of statin-related myopathy in VA (drug safety).

Aim 2 (Cardiovascular disease, CVD, prevention): To determine the impact of SLCO1B1 pharmacogenetic testing on LDL cholesterol levels and concordance with CVD prevention guidelines.

The I-PICC Study is enrolling 408 statin-naive primary care and women's health patients across the Veteran Affairs Boston Healthcare System. Eligible patients are aged 40-75 and have elevated risk of cardiovascular disease (CVD) according to American College of Cardiology/American Heart Association (ACC/AHA) guidelines. Primary care providers (PCPs) are also research subjects and consent via electronic health record (EHR) alerts. To model pharmacogenotyping at the point of care, the investigators are enrolling patients with recent cholesterol results when their PCPs order laboratory testing, indicating a moment of clinical decision-making about CVD risk. Enrolled patients are randomized to have their PCPs receive results through the EHR immediately (PGx+) vs. after 1 year (PGx-). The investigators will query clinical and pharmacy data for 1-year outcomes: myopathy and concordance with CPIC simvastatin guidelines (drug safety) and cholesterol levels and concordance with ACC/AHA guidelines (CVD risk reduction).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
Official Title: Clinical Safety and Efficacy of Pharmacogenetics in Veteran Care
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PGx+
Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately.
 Genetic: SLCO1B1 Genotype
Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
Other Name: SLCO1B1 Pharmacogenetic Test
Experimental: PGx-
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
Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
Other Name: SLCO1B1 Pharmacogenetic Test


Outcome Measures
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Primary Outcome Measures :
  1. 12-Month Change in LDL Cholesterol [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With an American College of Cardiology/American Heart Association (ACC/AHA) Guideline Concordant Statin Prescription at 12 Months [ Time Frame: 12 months ]
    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.

  2. Number of Participants With Chart Review Documented Statin-related Myotoxicity at 12 Months [ Time Frame: 12 months ]
    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.

  3. Number of Participants Meeting Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for Safe Simvastatin Prescription at 12 Months [ Time Frame: 12 months ]
    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.


Other Outcome Measures:
  1. Participant Response Distributions to Belief in Medications Questionnaire at 12 Months [ Time Frame: 12 months ]
    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."

  2. Number of Participants Recalling Pharmacogenetic Testing at 12 Months [ Time Frame: 12 months ]
    Assessed by phone survey 12 months after enrollment. Whether patient remembers receiving PGx results from provider and, if so, remembers the results and interpretation.

  3. Number of Participants Reporting Statin-related Muscle Side Effects at 12 Months [ Time Frame: 12 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871934


Locations
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United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Jason L Vassy, MD MPH VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Study Protocol and Statistical Analysis Plan  [PDF] January 28, 2019

More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02871934    
Other Study ID Numbers: SPLC-006-15S
IK2CX001262 ( U.S. NIH Grant/Contract )
First Posted: August 18, 2016    Key Record Dates
Results First Posted: February 21, 2022
Last Update Posted: February 21, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Pharmacogenetics
SLCO1B1 protein, human
OATP1B1 protein, human
Simvastatin
Cardiovascular disease
 Cholesterol
Statin-related myotoxicity
Veterans
Point-of-care
Additional relevant MeSH terms:
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Cardiovascular Diseases