Trial Outcomes & Findings for Integrating Pharmacogenetics In Clinical Care (NCT NCT02871934)

NCT ID: NCT02871934

Last Updated: 2022-02-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

408 participants

Primary outcome timeframe

12 months

Results posted on

2022-02-21

Participant Flow

Participant milestones

Participant milestones
Measure
PGx+
Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately. SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
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). SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
Overall Study
STARTED
193
215
Overall Study
COMPLETED
193
215
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Integrating Pharmacogenetics In Clinical Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
PGx+
n=193 Participants
Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately. SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
PGx-
n=215 Participants
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). SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
Total
n=408 Participants
Total of all reporting groups
Age, Continuous
64.2 years
STANDARD_DEVIATION 7.8 • n=99 Participants
63.9 years
STANDARD_DEVIATION 7.7 • n=107 Participants
64.1 years
STANDARD_DEVIATION 7.8 • n=206 Participants
Sex: Female, Male
Female
9 Participants
n=99 Participants
16 Participants
n=107 Participants
25 Participants
n=206 Participants
Sex: Female, Male
Male
184 Participants
n=99 Participants
199 Participants
n=107 Participants
383 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=99 Participants
6 Participants
n=107 Participants
8 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
187 Participants
n=99 Participants
208 Participants
n=107 Participants
395 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants
n=99 Participants
1 Participants
n=107 Participants
5 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Asian
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
25 Participants
n=99 Participants
25 Participants
n=107 Participants
50 Participants
n=206 Participants
Race (NIH/OMB)
White
156 Participants
n=99 Participants
185 Participants
n=107 Participants
341 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
3 Participants
n=99 Participants
1 Participants
n=107 Participants
4 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants
n=99 Participants
4 Participants
n=107 Participants
11 Participants
n=206 Participants
Region of Enrollment
United States
193 Participants
n=99 Participants
215 Participants
n=107 Participants
408 Participants
n=206 Participants
Smokers
59 Participants
n=99 Participants
78 Participants
n=107 Participants
137 Participants
n=206 Participants
Meeting ACC/AHA Criteria for Statin Therapy
ASCVD
52 Participants
n=99 Participants
46 Participants
n=107 Participants
98 Participants
n=206 Participants
Meeting ACC/AHA Criteria for Statin Therapy
LDL-C > 190 mg/dL
5 Participants
n=99 Participants
6 Participants
n=107 Participants
11 Participants
n=206 Participants
Meeting ACC/AHA Criteria for Statin Therapy
Diabetes
47 Participants
n=99 Participants
51 Participants
n=107 Participants
98 Participants
n=206 Participants
Meeting ACC/AHA Criteria for Statin Therapy
10-year ASCVD risk >= 7.5%
171 Participants
n=99 Participants
196 Participants
n=107 Participants
367 Participants
n=206 Participants
SLCO1B1 Genotype
Normal function (T/T)
148 Participants
n=99 Participants
140 Participants
n=107 Participants
288 Participants
n=206 Participants
SLCO1B1 Genotype
Decrease function (T/C)
40 Participants
n=99 Participants
70 Participants
n=107 Participants
110 Participants
n=206 Participants
SLCO1B1 Genotype
Poor function (C/C)
5 Participants
n=99 Participants
5 Participants
n=107 Participants
10 Participants
n=206 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
PGx+
n=193 Participants
Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately. SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
PGx-
n=215 Participants
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). SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
12-Month Change in LDL Cholesterol
-1.1 mg/dL
Standard Error 1.2
-2.2 mg/dL
Standard Error 1.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
PGx+
n=193 Participants
Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately. SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
PGx-
n=215 Participants
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). SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
Number of Participants With an American College of Cardiology/American Heart Association (ACC/AHA) Guideline Concordant Statin Prescription at 12 Months
12 Participants
14 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
PGx+
n=193 Participants
Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately. SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
PGx-
n=215 Participants
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). SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
Number of Participants With Chart Review Documented Statin-related Myotoxicity at 12 Months
2 Participants
3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
PGx+
n=193 Participants
Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately. SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
PGx-
n=215 Participants
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). SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
Number of Participants Meeting Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for Safe Simvastatin Prescription at 12 Months
193 Participants
215 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: Data analyzed only for patients who completed the 12-month end-of-study survey.

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."

Outcome measures

Outcome measures
Measure
PGx+
n=169 Participants
Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately. SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
PGx-
n=203 Participants
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). SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
Participant Response Distributions to Belief in Medications Questionnaire at 12 Months
"My health in the future will depend on my medicines." · Strongly agree
28 Participants
30 Participants
Participant Response Distributions to Belief in Medications Questionnaire at 12 Months
"My health in the future will depend on my medicines." · Agree
65 Participants
84 Participants
Participant Response Distributions to Belief in Medications Questionnaire at 12 Months
"My health in the future will depend on my medicines." · Uncertain
29 Participants
37 Participants
Participant Response Distributions to Belief in Medications Questionnaire at 12 Months
"My health in the future will depend on my medicines." · Disagree
29 Participants
40 Participants
Participant Response Distributions to Belief in Medications Questionnaire at 12 Months
"My health in the future will depend on my medicines." · Strongly disagree
17 Participants
12 Participants
Participant Response Distributions to Belief in Medications Questionnaire at 12 Months
"Medicines do more harm than good." · Strongly agree
9 Participants
10 Participants
Participant Response Distributions to Belief in Medications Questionnaire at 12 Months
"Medicines do more harm than good." · Agree
26 Participants
20 Participants
Participant Response Distributions to Belief in Medications Questionnaire at 12 Months
"Medicines do more harm than good." · Uncertain
46 Participants
56 Participants
Participant Response Distributions to Belief in Medications Questionnaire at 12 Months
"Medicines do more harm than good." · Disagree
63 Participants
89 Participants
Participant Response Distributions to Belief in Medications Questionnaire at 12 Months
"Medicines do more harm than good." · Strongly disagree
24 Participants
28 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: Result recall only assessed in intervention arm participants. Control participants received results 12 months after enrollment.

Assessed by phone survey 12 months after enrollment. Whether patient remembers receiving PGx results from provider and, if so, remembers the results and interpretation.

Outcome measures

Outcome measures
Measure
PGx+
n=169 Participants
Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately. SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
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). SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
Number of Participants Recalling Pharmacogenetic Testing at 12 Months
11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: Data analyzed only for patients who completed the 12-month end-of-study survey.

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.

Outcome measures

Outcome measures
Measure
PGx+
n=169 Participants
Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately. SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
PGx-
n=203 Participants
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). SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
Number of Participants Reporting Statin-related Muscle Side Effects at 12 Months
3 Participants
3 Participants

Adverse Events

PGx+

Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths

PGx-

Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jason Vassy

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

Phone: 857-364-2561

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place