Recruiting

Lipid Management

Sponsor:

Colorado Prevention Center

Code:

NCT07334834

Conditions

Hyperlipidemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Algorithm- and multi-professional team-supported lipid management

Guideline-directed lipid management by usual care provider

Study Details

Brief summary:

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).

Conditions

Hyperlipidemia

Study ID

NCT07334834

Start date

Dec 10, 2025

Status verified date

Jan, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Control: Guideline-directed lipid management by usual care provider

experimental: Algorithm- and multi-professional team-supported lipid management

Interventions

Algorithm- and multi-professional team-supported lipid management

Algorithm- and multi-professional team-supported lipid management

Guideline-directed lipid management by usual care provider

Guideline-directed lipid management by usual care provider

Primary outcome measure

  • The between group difference in LDL-C percent change [ Time Frame: Baseline to 3 months ]

Central Contacts and Locations

Central contacts

Marc Bonaca, MD

(303) 860-9900info@cpcmed.org

Sivan Naveh, MD. RPV

720-848-5300sivan.naveh@cpcmed.org

Locations

University of Colorado Health System (UCHealth)

Recruiting

Aurora, Colorado, United States, 80045

More Information

Sponsor

Colorado Prevention Center

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Keywords

  • Lipid Management
  • Atherosclerotic Cardiovascular Disease
  • Coronary Artery Disease
  • Peripheral Artery Disease
  • Carotid Artery Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Colorado Prevention Center on 2026-01-23.