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
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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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-12-10
2027-07-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control: Guideline-directed lipid management by usual care provider
Guideline-directed lipid management by usual care provider
Guideline-directed lipid management by usual care provider
Algorithm- and multi-professional team-supported lipid management
Algorithm- and multi-professional team-supported lipid management
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
Guideline-directed lipid management by usual care provider
Guideline-directed lipid management by usual care provider
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Planned active titration of current lipid-lowering therapy
* Myocardial infarction or arterial revascularization within prior 30 days
18 Years
ALL
No
Sponsors
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Colorado Prevention Center
OTHER
Responsible Party
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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
Countries
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Central Contacts
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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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