NCT07334834

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Dec 2025Jul 2027

Study Start

First participant enrolled

December 10, 2025

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

December 30, 2025

Last Update Submit

January 22, 2026

Conditions

Hyperlipidemia

Keywords

Lipid ManagementAtherosclerotic Cardiovascular DiseaseCoronary Artery DiseasePeripheral Artery DiseaseCarotid Artery Disease

Outcome Measures

Primary Outcomes (1)

  • The between group difference in LDL-C percent change

    Baseline to 3 months

Secondary Outcomes (3)

  • Between group difference

    Baseline to 1 and 6 months

  • Between group difference

    1, 3 and 6 months

  • Between group difference

    1, 3 and 6 months

Study Arms (2)

Control: Guideline-directed lipid management by usual care provider

OTHER
Other: Guideline-directed lipid management by usual care provider

Algorithm- and multi-professional team-supported lipid management

EXPERIMENTAL
Other: Algorithm- and multi-professional team-supported lipid management

Interventions

Algorithm- and multi-professional team-supported lipid managementOTHER

Algorithm- and multi-professional team-supported lipid management

Also known as: Experimental
Algorithm- and multi-professional team-supported lipid management
Guideline-directed lipid management by usual care providerOTHER

Guideline-directed lipid management by usual care provider

Also known as: Control
Control: Guideline-directed lipid management by usual care provider

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Health System (UCHealth)

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

HyperlipidemiasAtherosclerosisCoronary Artery DiseasePeripheral Arterial DiseaseCarotid Artery Diseases

Interventions

Algorithms

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesPeripheral Vascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Mathematical Concepts

Study Officials

  • Marc Bonaca, MD

    Colorado Prevention Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Bonaca, MD

CONTACT

(303) 860-9900info@cpcmed.org

Sivan Naveh, MD. RPV

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparative Effectiveness
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2025

First Posted

January 12, 2026

Study Start

December 10, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)