Optimizing non-statin cholesterol medicines for people with ASCVD

Using Pharmacy Extenders to Optimize Non-statin Agents for Secondary ASCVD Prevention Outcomes in a Federally Qualified Health Center

This project tests whether coordinated pharmacist support and changes to non-statin cholesterol medicines help people with ASCVD reach their LDL cholesterol goals.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Texas at Austin (Academic / other)
• Locations: 1 site (Austin, Texas)
• Trial ID: NCT07464574 on ClinicalTrials.gov

What this trial studies

This prospective observational project will identify about 1,000 adults with documented clinical ASCVD from CommUnityCare records. Clinical pharmacists and pharmacy interns will contact participants by phone, review medications and recent lipid panels, coordinate follow-up (including local fasting labs if needed), and recommend non-statin therapy changes following current AHA/ACC guidance. Medication changes and counseling are delivered as part of routine clinical pharmacy care, and the team will collect data on visits, medicines, and LDL levels for six months. Follow-up may occur in-person or via telehealth and uses standard-of-care workflows at CommUnityCare.

Who should consider this trial

Good fit: Adults (>18) with documented clinical ASCVD who have seen a CommUnityCare provider in the past 12 months and are not meeting LDL targets (<55 or <70 mg/dL based on risk) are the ideal candidates.

Not a fit: Patients already at LDL targets, managed by an outside cardiologist/lipid specialist, without documented ASCVD, currently pregnant, or not followed at CommUnityCare in the past year are unlikely to receive benefit from this program.

Why it matters

Potential benefit: If successful, it could lower LDL cholesterol and improve medication management to reduce future cardiovascular risk.

How similar studies have performed: Prior pharmacist-led programs and trials of non-statin therapies have demonstrated improved LDL control, so this approach builds on existing evidence.

Eligibility criteria

Inclusion Criteria:

* Adult patients (\>18 years) who have seen a CommUnityCare provider in the previous 12 months at time of enrollment, who have a documented history of clinical ASCVD, and are not achieving LDL targets (either \<55 or \<70 mg/dL based on risk factors)

Exclusion Criteria:

* Patients will be excluded if they do not have a clearly documented history clinical ASCVD, are already achieving LDL targets (either \<55 or \<70 mg/dL based on risk factors), having cholesterol managed by outside provider (e.g. outside cardiologist/lipid specialist), current pregnancy, have not seen a CUC provider in the previous 12 months, or otherwise do not qualify for clinical pharmacy intervention

Where this trial is running

Austin, Texas

• CommUnityCare Health Centers — Austin, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Morgan Stewart, PharmD

Conditions ASCVD Management; non-statin