NCT06571162

A Pragmatic INitiative for LDL-C Management by a CLinical Pharmacist-Led Team Among Atherosclerotic CardiovascUlar DisEase Patients

A Pragmatic INitiative for LDL-C Management by a CLinical Pharmacist-Led Team Among Atherosclerotic CardiovascUlar DisEase Patients (The INCLUDE Trial)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Intermountain Health Care, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients who had an ASCVD event at an Intermountain hospital will be screened for eligibility to be randomized. Subjects who meet eligibility criteria will be randomized 1:1 to receive targeted care of their LDL-C through a pharmacist-driven management program or not. Patients may opt-out of receiving LDL-C management by the pharmacy team at any time. The purpose of this program is to increase the proportion of patients who achieve guideline-based recommendations of LDL-C levels of \<70 mg/dL by increasing statin and/or LLT adherence and LDL-C testing. Data collection as part of the study will continue until the last person randomized has had 1-year of follow-up.

Conditions

• Atherosclerotic Cardiovascular Disease

Interventions

Type	Name	Description
OTHER	Clinical Pharmacy Team	Patients will receive targeted care of their LDL-C through a pharmacist-driven management program.
OTHER	Usual Care	Patient will receive usual care for their LDL-C management.

Timeline

• Start date: 2025-01-30
• Primary completion: 2028-01-01
• Completion: 2028-09-01
• First posted: 2024-08-26
• Last updated: 2025-05-06

Locations

1 site across 1 country: United States