Managing LDL cholesterol levels in patients with cardiovascular disease through a pharmacist-led program
Official title: A Pragmatic INitiative for LDL-C Management by a CLinical Pharmacist-Led Team Among Atherosclerotic CardiovascUlar DisEase Patients (The INCLUDE Trial)
Run by Intermountain Health Care, Inc. · NCT06571162 · Data updated 2026-11-12
This study is testing if a pharmacist-led program can help people with heart disease lower their LDL cholesterol levels better than regular care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Intermountain Health Care, Inc. Academic / other |
| Locations | 1 site (Salt Lake City, Utah) |
| Status | Recruiting |
| Started | January 30, 2025 |
| Main results expected | January 2028 |
| Study ends | September 2028 |
| Registry record updated | May 6, 2025 |
| Trial ID | NCT06571162 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old with a documented diagnosis of ASCVD receiving follow-up care at Intermountain Health.
✕Probably not a fit
Patients under 18 years old, those receiving palliative care, or pregnant or lactating women may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This initiative focuses on patients who have experienced an atherosclerotic cardiovascular disease (ASCVD) event and are receiving follow-up care at Intermountain Health. Eligible participants will be randomly assigned to receive either targeted LDL-C management by a clinical pharmacy team or usual care. The goal is to improve adherence to statin and lipid-lowering therapies and achieve guideline-recommended LDL-C levels of less than 70 mg/dL. Data will be collected for one year following randomization to assess the effectiveness of the intervention.
Why it matters
Potential benefit: If successful, this program could significantly improve cholesterol management and reduce cardiovascular risks for patients with ASCVD.
How similar studies have gone: Other studies have shown that pharmacist-led interventions can effectively improve medication adherence and health outcomes in similar patient populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female \>18 years of age 2. Receive follow-up care with Intermountain Health 3. Value-based patient (as defined in the EDW) 4. Documentation of an ASCVD diagnosis, by 1 of the following: * Coronary artery disease (Primary inpatient CAD diagnosis during index encounter; Primary inpatient MI diagnosis during index encounter; PCI during index encounter; or CABG during index encounter * Cerebrovascular accident (Primary inpatient ischemic stroke diagnosis during index encounter; Carotid endarterectomy during index encounter; or Carotid stent during index encounter) * Peripheral arterial disease (Bypass or percutaneous intervention during index encounter) Exclusion Criteria: 1. Patient age \<18 years. 2. Receipt of or expected receipt of palliative care, expected discharge to hospice, or long-term care facility (i.e., skilled nursing facility). 3. Pregnant or lactating women
Where it's running
-
Intermountain Healthcare Hospitals and Clinics
Salt Lake City, Utah, United States Recruiting
Study contacts
- Study coordinator: Kirk U Knowlton, MD
- Email: kirk.knowlton@imail.org
- Phone: 801-507-4757
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.