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

NCT ID: NCT07334834

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-10

Study Completion Date

2027-07-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparative Effectiveness
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control: Guideline-directed lipid management by usual care provider

Group Type OTHER

Guideline-directed lipid management by usual care provider

Intervention Type OTHER

Guideline-directed lipid management by usual care provider

Algorithm- and multi-professional team-supported lipid management

Group Type EXPERIMENTAL

Algorithm- and multi-professional team-supported lipid management

Intervention Type OTHER

Algorithm- and multi-professional team-supported lipid management

Interventions

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Algorithm- and multi-professional team-supported lipid management

Algorithm- and multi-professional team-supported lipid management

Intervention Type OTHER

Guideline-directed lipid management by usual care provider

Guideline-directed lipid management by usual care provider

Intervention Type OTHER

Other Intervention Names

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Experimental Control

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Colorado Prevention Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Bonaca, MD

Role: PRINCIPAL_INVESTIGATOR

Colorado Prevention Center

Locations

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University of Colorado Health System (UCHealth)

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Marc Bonaca, MD

Role: CONTACT

(303) 860-9900

Sivan Naveh, MD. RPV

Role: CONTACT

720-848-5300

Facility Contacts

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Marc Bonaca, MD

Role: primary

Other Identifiers

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202401CPC

Identifier Type: -

Identifier Source: org_study_id

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