Actively Recruiting
Implementation of an Algorithm- and Multi-professional Team-supported Strategy to Improve Lipid Management of Patients With Atherosclerotic Cardiovascular Disease
Led by Colorado Prevention Center · Updated on 2026-01-23
100
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a strategy supported by an algorithm and a multi-professional team can better manage lipid levels compared to usual care in patients with atherosclerotic cardiovascular disease (ASCVD). This randomized, controlled, multicenter pilot study aims to see if this approach reduces low-density lipoprotein cholesterol (LDL-C) more effectively. The study involves about 100 participants and explores different lipid management methods to improve cardiovascular health. Participants will be randomly assigned to one of two groups. One group receives lipid management guided by an algorithm and supported by a team including physicians and pharmacists who provide education and help with medication access. The other group receives guideline-directed lipid management from their usual care providers. Participants' preferences for injectable or oral lipid therapy are recorded at the start. This open-label study uses local certified labs for blood tests and collects patient-reported outcomes electronically. During the study, participants will undergo evaluations including LDL-C measurements at baseline, 1, 3, and 6 months. Data from electronic medical records and patient questionnaires will be used to monitor progress. The main outcome is the difference in LDL-C percentage change from baseline to 3 months between groups. Safety and adherence will be monitored by study leadership, and participation is expected to last at least 6 months with ongoing data collection and support.
CONDITIONS
Brief Title
Implementation of an Algorithm- and Multi-professional Team-supported Strategy to Improve Lipid Management of Patients With Atherosclerotic Cardiovascular Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent
- Age over 18 years at screening
- Documented atherosclerotic vascular disease such as coronary artery disease, peripheral artery disease, carotid artery disease, or atherosclerosis in other vascular areas
- LDL cholesterol greater than 70 mg/dL
You will not qualify if you...
- Unable to adhere to the study protocol or participation might cause harm (e.g., terminal illness, metastatic cancer)
- Planned active adjustment (titration) of current lipid-lowering therapy
- Heart attack or arterial revascularization within the past 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 6 months
Participants receive either algorithm- and multi-professional team-supported lipid management or guideline-directed lipid management by their usual care provider to manage LDL cholesterol.
Visits or contacts at baseline, 1 month, 3 months, and 6 months
Trial Site Locations
Total: 1 location
1
University of Colorado Health System (UCHealth)
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
M
Marc Bonaca, MD
S
Sivan Naveh, MD. RPV
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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