An interventional study of Algorithm- and multi-professional team-supported lipid management and Guideline-directed lipid management by usual care provider in Hyperlipidemia, sponsored by Colorado Prevention Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Colorado Prevention Center · Not applicable, Interventional, and Treatment
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).
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).
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.
861 studies on the registry are indexed under Hyperlipidemias; 110 are open to participants now.
This study's planned enrollment of 100 is above the median of 88 across 735 interventional studies indexed under Hyperlipidemias.
Browse Hyperlipidemias studies →Colorado Prevention Center is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Documented atherosclerotic vascular disease including:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Guideline-directed lipid management by usual care provider
Other: Algorithm- and multi-professional team-supported lipid management
Algorithm- and multi-professional team-supported lipid management
Also known as: Experimental
Guideline-directed lipid management by usual care provider
Also known as: Control
The between group difference in LDL-C percent change
Time frame: Baseline to 3 months
Between group difference
LDL-C percent change
Time frame: Baseline to 1 and 6 months
Between group difference
The proportion achieving LDL-C \<55 mg/dL
Time frame: 1, 3 and 6 months
Between group difference
Proportion receiving combination lipid lowering Therapy
Time frame: 1, 3 and 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for May 2027, 17 months after the start.
Of 166 non-industry interventional studies with no phase under Hyperlipidemias, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's planned 17 months is close to that.
Counting every sponsor, half of 171 studies reached it within 15 months; a quarter within 7 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Colorado Prevention Center