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

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

This is a randomized, controlled, collaborative, multicenter, pilot implementation science study evaluating the hypothesis that algorithm- and multi-professional team-supported lipid management reduces low density lipoprotein-cholesterol (LDL-C) compared with usual care in patients with atherosclerotic cardiovascular disease (ASCVD).

Study Overview

• Status: Recruiting
• Conditions: Hyperlipidemia
• Intervention / Treatment: Other: Guideline-directed lipid management by usual care provider; Other: Algorithm- and multi-professional team-supported lipid management

Detailed Description

OPTIMIZE-ASCVD is a randomized, controlled, collaborative, open-label, multicenter pilot implementation science study evaluating the hypothesis that algorithm- (Appendix A) and multi-professional team-supported lipid management reduces LDL-C compared with usual care in patients with ASCVD.

Approximately 100 participants will be randomized (1:1).

• Participant preference for injectable vs oral lipid therapy will be recorded at baseline.
• Participants allocated to algorithm-and multi-professional team-supported lipid management will be evaluated by a physician and prescribed lipid therapy which aims to achieve LDL-C target without titration. Participants will be contacted by a pharmacist to provide education about the medication and support any access issues.
• Participants allocated to usual care will be referred for management by their usual care provider who will receive a summary of guideline recommendations

The study will include decentralized clinical trial features including use of local, Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories for blood tests, use of data extracted from the electronic medical record (EMR), electronic collection of patient-reported outcomes (PRO) and remote conduct of study activities. As an open label study with both strategy groups receiving GDMT, no Data and Safety Monitoring Committee will be convened. Study leadership will monitor aggregate data during the trial and may modify the sample size and/or cap enrollment of subgroups to ensure consistency with design assumptions.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc Bonaca, MD; Phone Number: (303) 860-9900; Email: info@cpcmed.org
• Study Contact Backup: Name: Sivan Naveh, MD. RPV; Phone Number: 720-848-5300; Email: sivan.naveh@cpcmed.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Health System (UCHealth)
      • Contact: Marc Bonaca, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control: Guideline-directed lipid management by usual care provider	Other: Guideline-directed lipid management by usual care provider; Guideline-directed lipid management by usual care provider; Other Names: Control
Experimental: Algorithm- and multi-professional team-supported lipid management	Other: Algorithm- and multi-professional team-supported lipid management; Algorithm- and multi-professional team-supported lipid management; Other Names: Experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The between group difference in LDL-C percent change	Baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between group difference	LDL-C percent change	Baseline to 1 and 6 months
Between group difference	The proportion achieving LDL-C <55 mg/dL	1, 3 and 6 months
Between group difference	Proportion receiving combination lipid lowering Therapy	1, 3 and 6 months

Collaborators and Investigators

• Sponsor: Colorado Prevention Center
• Investigators: Principal Investigator: Marc Bonaca, MD, Colorado Prevention Center

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Actual): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Peripheral Artery Disease; Carotid Artery Disease; Atherosclerotic Cardiovascular Disease; Lipid Management
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Coronary Disease; Myocardial Ischemia; Nutritional and Metabolic Diseases; Carotid Artery Diseases; Peripheral Arterial Disease; Coronary Artery Disease; Atherosclerosis; Hyperlipidemias; Mathematical Concepts; Algorithms
• Other Study ID Numbers: 202401CPC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No