Evaluation of Pharmacist Interventions in Lipid Management for Secondary Prevention

NCT ID: NCT06647238

Last Updated: 2025-07-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-05

Study Completion Date

2025-05-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperlipidemia Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Control group will not directly interact with investigators. Will perform retrospective chart review only.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pharmacist Intervention

Pharmacist review of patient chart and follow up visits to prescribe appropriate therapy for hyperlipidemia.

Group Type EXPERIMENTAL

Pharmacist Intervention in lipid therapy

Intervention Type OTHER

Pharmacist intervention may include but is not limited to prescribing (statins, ezetimibe, bempedoic acid, PCSK9 inhibitors, etc.), patient education, and medication access.

Control

Chart review only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kayla Marvin, PharmD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Atrium Health Cabarrus

Concord, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB00118029

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pharmacists Management of Diabetes
NCT00869076 COMPLETED PHASE4
Evaluation of PatientToc in Community Pharmacies
NCT05235620 ENROLLING_BY_INVITATION