HyperlipidemiaOPTIMIZE ASCVDNCT07334834
Implementation of an Algorithm- and Multi-professional Team-supported Strategy to Improve Lipid Management of Patients With Atherosclerotic Cardiovascular Disease
A study testing Algorithm- and multi-professional team-supported lipid management in people with Hyperlipidemia, run by Colorado Prevention Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Algorithm- and multi-professional team-supported lipid management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Health System (UCHealth)
Aurora, Colorado, 80045
Marc Bonaca, MD
About this study
Official title: Implementation of an Algorithm- and Multi-professional Team-supported Strategy to Improve Lipid Management of Patients With Atherosclerotic Cardiovascular Disease: OPTIMIZE ASCVD
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).
Read the detailed description
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
- Hyperlipidemia
- Being tested
- Algorithm- and multi-professional team-supported lipid management, Guideline-directed lipid management by usual care provider
- Keywords
- Lipid Management, Atherosclerotic Cardiovascular Disease, Coronary Artery Disease, Peripheral Artery Disease, Carotid Artery Disease
- Medical subject headings
- Hyperlipidemias, Atherosclerosis, Coronary Artery Disease, Peripheral Arterial Disease, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algorithm- and multi-professional team-supported lipid managementOther
Also called Experimental
Algorithm- and multi-professional team-supported lipid management
Guideline-directed lipid management by usual care providerOther
Also called Control
Guideline-directed lipid management by usual care provider
| Study group | Role | What they receive |
|---|---|---|
| Control: Guideline-directed lipid management by usual care provider | Other | Not described Receives: Other: Guideline-directed lipid management by usual care provider |
| Algorithm- and multi-professional team-supported lipid management | Experimental | Not described Receives: Other: Algorithm- and multi-professional team-supported lipid management |
What is being measured
The primary outcome is the main question the study is designed to answer.
The between group difference in LDL-C percent change
Measured: Baseline to 3 months
Secondary outcomes (3)
Between group difference
LDL-C percent change
Measured: Baseline to 1 and 6 months
Between group difference
The proportion achieving LDL-C <55 mg/dL
Measured: 1, 3 and 6 months
Between group difference
Proportion receiving combination lipid lowering Therapy
Measured: 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start10 Dec 2025
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative Effectiveness
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado Prevention Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Bonaca, MD, Principal investigator, Colorado Prevention Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334834
- Sponsor's protocol ID
- 202401CPC
- Acronym
- OPTIMIZE ASCVD
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Algorithm- and Multi-professional Team-supported Strategy to Improve Lipid Management of Patients With Atherosclerotic Cardiovascular Disease: OPTIMIZE ASCVD
- ClinicalTrials.gov ID
- NCT07334834
- Acronym / sponsor ID
- OPTIMIZE ASCVD / 202401CPC
- Conditions
- Hyperlipidemia
- Keywords
- Lipid Management, Atherosclerotic Cardiovascular Disease, Coronary Artery Disease, Peripheral Artery Disease, Carotid Artery Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Colorado Prevention CenterUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparative Effectiveness
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provided informed consent
- Age >18 years inclusive at screening
- Documented atherosclerotic vascular disease including:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Algorithm- and multi-professional team-supported lipid managementAlso: ExperimentalAlgorithm- and multi-professional team-supported lipid management | Other | Algorithm- and multi-professional team-supported lipid management |
| Guideline-directed lipid management by usual care providerAlso: ControlGuideline-directed lipid management by usual care provider | Other | Control: Guideline-directed lipid management by usual care provider |
Primary outcome
The between group difference in LDL-C percent change
Time frame: Baseline to 3 months
3 secondary outcomes
Between group difference
Time frame: Baseline to 1 and 6 months
Between group difference
Time frame: 1, 3 and 6 months
Between group difference
Time frame: 1, 3 and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc Bonaca, MD principal investigator
Colorado Prevention Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algorithm- and multi-professional team-supported lipid management in people with Hyperlipidemia, run by Colorado Prevention Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Bonaca, MD ((303) 860-9900, info@cpcmed.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The between group difference in LDL-C percent change (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.