Using an algorithm and team-based care to improve cholesterol in people with atherosclerotic cardiovascular disease

Implementation of an Algorithm- and Multi-professional Team-supported Strategy to Improve Lipid Management of Patients With Atherosclerotic Cardiovascular Disease: OPTIMIZE ASCVD

This project will see if using an algorithm plus a physician-and-pharmacist team to guide lipid treatment lowers LDL cholesterol in people with atherosclerotic cardiovascular disease compared with usual care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Colorado Prevention Center (other)
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT07334834 on ClinicalTrials.gov

What this trial studies

OPTIMIZE-ASCVD is a randomized, open-label, multicenter pilot that will randomize about 100 participants 1:1 to an algorithm- and multi-professional team-supported lipid management strategy or to usual guideline-directed care. The intervention arm uses a prescribing physician who targets an LDL-C goal without iterative titration and a pharmacist who provides medication education and helps with access issues. Usual care participants are managed by their regular providers who receive guideline summaries. The study uses decentralized elements including local CLIA-certified labs, EMR data extraction, electronic patient-reported outcomes, and remote study activities.

Who should consider this trial

Good fit: Adults with documented atherosclerotic vascular disease (coronary, peripheral, carotid, or other arterial beds) and LDL-C over 70 mg/dL who can provide informed consent are ideal candidates.

Not a fit: Patients already at LDL targets, those with very limited life expectancy, or those unable to follow study procedures are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, patients could reach lower LDL-C levels more quickly and consistently through protocol-driven therapy and team support.

How similar studies have performed: Previous implementation and team-based lipid programs have improved LDL control in other settings, but this randomized pilot combining an algorithm with multi-professional support is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Provided informed consent
* Age \>18 years inclusive at screening
* Documented atherosclerotic vascular disease including:

  * Coronary artery disease (prior revascularization, myocardial infarction, imaging evidence of coronary atherosclerosis)
  * Peripheral artery disease (prior revascularization, amputation, ankle: brachial index (ABI) ≤ 0.90, imaging evidence of extra-coronary atherosclerosis)
  * Carotid artery disease (prior endarterectomy or stenting of the extracranial carotid artery or imaging evidence of carotid atherosclerosis)
  * Imaging evidence of atherosclerotic vascular disease in a non-coronary vascular bed (e.g. aorta, mesenteric, renal)
  * LDL-C \>70mg/dL

Exclusion Criteria:

* Any reason that, in the opinion of the investigator, the patient would be unable to adhere to the protocol for the duration of the study (e.g. terminal diagnosis, metastatic cancer) or in whom participation might result in harm.
* Planned active titration of current lipid-lowering therapy
* Myocardial infarction or arterial revascularization within prior 30 days

Where this trial is running

Aurora, Colorado

• University of Colorado Health System (UCHealth) — Aurora, Colorado, United States (RECRUITING)

Study contacts

• Principal investigator: Marc Bonaca, MD — Colorado Prevention Center
• Study coordinator: Marc Bonaca, MD

Conditions: Hyperlipidemia, Lipid Management, Atherosclerotic Cardiovascular Disease, Coronary Artery Disease, Peripheral Artery Disease, Carotid Artery Disease