Evaluation of Pharmacist Interventions in Lipid Management for Secondary Prevention

July 2, 2025 updated by: Wake Forest University Health Sciences

Second Time's the Charm: Evaluation of Pharmacist Interventions in Lipid Management for Secondary Prevention

The primary objective of this research project is to compare the effect of pharmacist interventions versus usual care in the implementation of guideline directed lipid lowering therapies for secondary prevention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Studies have shown prevention of cardiovascular adverse events is directly proportional to percent reduction in low-density lipoprotein (LDL). This evidence explains why LDL targets for secondary prevention have continued to be lowered. Cholesterol guidelines have been updated recently and encourage the use of multiple lipid lowering therapies, in addition to statins, for secondary prevention. However, these novel agents can be expensive and difficult to acquire, making prescribing challenging for providers.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Concord, North Carolina, United States, 28025
        • Atrium Health Cabarrus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of coronary artery disease
  • low-density lipoprotein (LDL) > 55
  • Primary Care Physician at 1 of 6 identified clinics

Exclusion Criteria:

  • Patients who are no longer an active patient of one of the internal medicine practices
  • Patients whose cholesterol is managed by another practice
  • Women of childbearing age/potential
  • Patients residing in hospice/Long Term Care facilities
  • End-stage liver disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pharmacist Intervention
Pharmacist review of patient chart and follow up visits to prescribe appropriate therapy for hyperlipidemia.
Other: Pharmacist Intervention in lipid therapy
Pharmacist intervention may include but is not limited to prescribing (statins, ezetimibe, bempedoic acid, PCSK9 inhibitors, etc.), patient education, and medication access.
No Intervention: Control
Chart review only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Who Meet Low-density Lipoprotein (LDL) at Goal (<55)
Time Frame: Month 5
patients with LDL within goal (<55) (yes/no)
Month 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Low-density Lipoprotein (LDL)
Time Frame: Baseline to end of study period up to Month 5
Percent LDL reduction (will use baseline LDL and lowest LDL)
Baseline to end of study period up to Month 5
Number of Participants With Medications Initiated or Titrated
Time Frame: Baseline to end of study period up to Month 5
Number of Medications initiated or titrated
Baseline to end of study period up to Month 5
Prevalence of Elevated Lipoprotein(a)
Time Frame: Baseline to end of study period up to Month 5
Number of Subjects with Prevalence of elevated Lipoprotein(a)
Baseline to end of study period up to Month 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Kayla Marvin, PharmD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2024

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

May 27, 2025

Study Registration Dates

First Submitted

October 16, 2024

First Submitted That Met QC Criteria

October 16, 2024

First Posted (Actual)

October 17, 2024

Study Record Updates

Last Update Posted (Actual)

July 22, 2025

Last Update Submitted That Met QC Criteria

July 2, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00118029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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