Trial Outcomes & Findings for Evaluation of Pharmacist Interventions in Lipid Management for Secondary Prevention (NCT NCT06647238)
NCT ID: NCT06647238
Last Updated: 2025-07-22
Results Overview
patients with LDL within goal (\<55) (yes/no)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Month 5
Results posted on
2025-07-22
Participant Flow
Participant milestones
| Measure |
Pharmacist Intervention
Pharmacist review of patient chart and follow up visits to prescribe appropriate therapy for hyperlipidemia.
|
Control
Chart review only
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Pharmacist Interventions in Lipid Management for Secondary Prevention
Baseline characteristics by cohort
| Measure |
Pharmacist Intervention
n=40 Participants
Pharmacist review of patient chart and follow up visits to prescribe appropriate therapy for hyperlipidemia.
|
Control
n=40 Participants
Chart review only
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.13 years
STANDARD_DEVIATION 12.53 • n=99 Participants
|
74.3 years
STANDARD_DEVIATION 8.43 • n=107 Participants
|
70.7 years
STANDARD_DEVIATION 11.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
44 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
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
CVD History
STEMI
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
CVD History
NSTEMI
|
5 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
CVD History
Ischemic stroke
|
26 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
CVD History
Symptomatic PAD
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
CVD History
Other
|
14 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Pertinent Past Medical History
Prior CABG/PCI
|
10 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Pertinent Past Medical History
Diabetes
|
30 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Pertinent Past Medical History
Hypertension
|
36 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Pertinent Past Medical History
Chronic Kidney Disease
|
17 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Pertinent Past Medical History
Chronic Heart Failure
|
8 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Pertinent Past Medical History
Current Smoker
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
LDL
|
88.36 md/dL
STANDARD_DEVIATION 30.02 • n=99 Participants
|
88.45 md/dL
STANDARD_DEVIATION 34.03 • n=107 Participants
|
88.41 md/dL
STANDARD_DEVIATION 31.91 • n=206 Participants
|
|
History of Statin Intolerance
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Baseline Treatment
High-intensity statin
|
28 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Baseline Treatment
Low or moderate-intensity statin
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Baseline Treatment
Ezetimibe
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Baseline Treatment
Bile Acid Sequestrant
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Baseline Treatment
Fish Oil
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Baseline Treatment
Fibrate
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Baseline Treatment
None
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Baseline Treatment
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Insurance Type
Medicaid
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Insurance Type
Medicare
|
25 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Insurance Type
Commercial
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Insurance Type
Tricare
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Insurance Type
Self-pay
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Insurance Type
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Month 5patients with LDL within goal (\<55) (yes/no)
Outcome measures
| Measure |
Pharmacist Intervention
n=40 Participants
Pharmacist review of patient chart and follow up visits to prescribe appropriate therapy for hyperlipidemia.
|
Control
n=40 Participants
Chart review only
|
|---|---|---|
|
Number of Subjects Who Meet Low-density Lipoprotein (LDL) at Goal (<55)
|
17 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline to end of study period up to Month 5Percent LDL reduction (will use baseline LDL and lowest LDL)
Outcome measures
| Measure |
Pharmacist Intervention
n=40 Participants
Pharmacist review of patient chart and follow up visits to prescribe appropriate therapy for hyperlipidemia.
|
Control
n=40 Participants
Chart review only
|
|---|---|---|
|
Percent Change in Low-density Lipoprotein (LDL)
|
-32.9 percent of change in low-density lipopro
Standard Deviation 0.24
|
-6.8 percent of change in low-density lipopro
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Baseline to end of study period up to Month 5Number of Medications initiated or titrated
Outcome measures
| Measure |
Pharmacist Intervention
n=40 Participants
Pharmacist review of patient chart and follow up visits to prescribe appropriate therapy for hyperlipidemia.
|
Control
n=40 Participants
Chart review only
|
|---|---|---|
|
Number of Participants With Medications Initiated or Titrated
Statin Adjustment
|
10 Participants
|
3 Participants
|
|
Number of Participants With Medications Initiated or Titrated
Ezetimibe Initiation
|
18 Participants
|
1 Participants
|
|
Number of Participants With Medications Initiated or Titrated
PCKS9i initiation
|
6 Participants
|
0 Participants
|
|
Number of Participants With Medications Initiated or Titrated
Fenofibrate initiation
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to end of study period up to Month 5Population: No patients in the control arm had lipoprotein(a) tested during the study period.
Number of Subjects with Prevalence of elevated Lipoprotein(a)
Outcome measures
| Measure |
Pharmacist Intervention
n=24 Participants
Pharmacist review of patient chart and follow up visits to prescribe appropriate therapy for hyperlipidemia.
|
Control
Chart review only
|
|---|---|---|
|
Prevalence of Elevated Lipoprotein(a)
|
7 Participants
|
0 Participants
|
Adverse Events
Pharmacist Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place