Pharmacist Interventions in Cholesterol Management of Very High Risk Patients

Not Applicable

Active, not recruiting

• Conditions: Hyperlipidemia; Coronary Artery Disease

• Registration Number: NCT06647238
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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 Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-16
• Study First Submitted QC: 2024-10-16
• Study First Posted: 2024-10-17
• Study Start: 2024-11-05
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Subjects who meet low-density lipoprotein (LDL) at goal (<55)	Month 5	patients with LDL within goal (\<55) (yes/no)

Secondary Outcome Measures

Name	Time	Method
Percent change in low-density lipoprotein (LDL)	Baseline to end of study period up to Month 5	Percent LDL reduction (will use baseline LDL and lowest LDL)
Number of Medication related problems identified and solved	Baseline to end of study period up to Month 5	Number of Medication related problems identified and solved
Number of Medications initiated or titrated	Baseline to end of study period up to Month 5	Number of Medications initiated or titrated
Number of patients provided assistance with medication access	Baseline to end of study period up to Month 5	Number of patients provided assistance with medication access
Number of Subjects with Prevalence of elevated Lipoprotein(a)	Baseline to end of study period up to Month 5	Number of Subjects with Prevalence of elevated Lipoprotein(a)

Trial Locations

Locations (1)

Atrium Health Cabarrus; 🇺🇸 Concord, North Carolina, United States