Algorithm-Supported Lipid Management for Atherosclerosis

(OPTIMIZE ASCVD Trial)

Overseen By Marc Bonaca, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Colorado Prevention Center

Disqualifiers: Terminal diagnosis, Metastatic cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage cholesterol in people with atherosclerosis, a condition where plaque buildup narrows arteries and leads to heart problems. The study compares two approaches: one uses a special algorithm and a team of health professionals (algorithm- and multi-professional team-supported lipid management), while the other follows standard care by a regular doctor (guideline-directed lipid management by usual care provider). The goal is to determine if the new method can lower bad cholesterol (LDL-C) more effectively. Suitable participants have atherosclerosis and a cholesterol level over 70mg/dL but have not had recent heart procedures or changes in their treatment plan. This trial offers a chance to try a new treatment approach. As an unphased trial, it provides a unique opportunity to explore innovative treatment strategies that could enhance health management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are planning to change your current lipid-lowering therapy, you may not be eligible to participate.

What prior data suggests that this algorithm- and multi-professional team-supported lipid management is safe for patients with atherosclerotic cardiovascular disease?

Research has shown that lipid-lowering therapies, which reduce cholesterol, are generally well-tolerated. These treatments lower "bad" cholesterol (LDL-C) levels, reducing the risk of heart disease. Past studies have demonstrated significant drops in LDL-C with few serious side effects. While some individuals may experience minor issues like muscle aches, these are uncommon.

In this trial, a team and a computer program will organize and guide the treatment process. The trial does not test a new drug; instead, it uses existing treatments in a new way. Therefore, the safety of these treatments is expected to align with existing knowledge. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how an algorithm, combined with a multi-professional team, can enhance lipid management for atherosclerosis. Unlike standard treatments that rely solely on a healthcare provider's guidance, this approach uses technology to tailor care, which could lead to more personalized and effective management of blood lipid levels. By integrating input from various health professionals, it aims to optimize treatment strategies beyond traditional methods, potentially improving outcomes for patients with atherosclerosis.

What evidence suggests that this trial's treatments could be effective for atherosclerosis?

Research has shown that a computer program combined with a team of healthcare professionals can significantly lower LDL cholesterol, often called "bad" cholesterol, in people with heart disease. In this trial, participants will receive either algorithm- and multi-professional team-supported lipid management or guideline-directed lipid management by their usual care provider. Studies have found that combining different treatments, such as medications and lifestyle changes, effectively reduces LDL levels. These computer programs offer an accurate way to address high cholesterol, helping doctors better achieve treatment goals. This method aims not only to lower cholesterol but also to reduce the overall risk of heart disease. ^{1 3 4 6 7}

Who Is on the Research Team?

Marc Bonaca, MD

Principal Investigator

Colorado Prevention Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with documented atherosclerotic vascular disease, such as coronary artery disease, peripheral artery disease, or carotid artery disease. Participants must have LDL cholesterol levels above 70mg/dL and be able to follow the study protocol. Those who've had recent heart attacks or revascularization, or can't adhere to the study are excluded.

Inclusion Criteria

I have heart or blood vessel disease and my LDL cholesterol is over 70mg/dL.

Provided informed consent

I am over 18 years old.

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

I am adjusting my current cholesterol medication.

I have not had a heart attack or any artery-opening procedures in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participant preference for injectable vs oral lipid therapy is recorded

1 week

Treatment

Participants receive algorithm- and multi-professional team-supported lipid management or usual care

6 months

Remote conduct of study activities with decentralized clinical trial features

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Algorithm- and multi-professional team-supported lipid management
• Guideline-directed lipid management by usual care provider

Trial Overview

The study compares usual care lipid management with an innovative approach using algorithms and a multi-professional team. It aims to see if this new method is more effective in reducing bad cholesterol (LDL-C) in patients with cardiovascular diseases linked to atherosclerosis.

How Is the Trial Designed?

Group I: Control: Guideline-directed lipid management by usual care provider Experimental Treatment 1 Intervention

Group II: Algorithm- and multi-professional team-supported lipid management Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Colorado Prevention Center

Lead Sponsor

Trials

13

Recruited

22,600+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07334834

NCT07334834 | Implementation of an Algorithm- and Multi- ...

This is a randomized, controlled, collaborative, multicenter, pilot implementation science study evaluating the hypothesis that algorithm- and ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12277597/

A Critical Appraisal of Lipid Management in the Post-Statin Era

Lipid-lowering therapies (LLT) are a cornerstone in the management of ASCVD risk by causing significant reductions in LDL-C and adverse ...

3.

endocrinepractice.org

endocrinepractice.org/article/S1530-891X(25)00972-3/fulltext

Algorithm for Management of Adults with Dyslipidemia ...

This 2025 algorithm emphasizes lifestyle modification, the importance of managing atherosclerotic risk factors, and provides a framework regarding ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666667726000115

Progress in Risk Assessment and Management

An ASCVD risk-based approach should be the foundation for determining LDL-C goals with consideration that multiple lipid-lowering therapies are ...

5.

escardio.org

escardio.org/The-ESC/Press-Office/Press-releases/New-guidance-recommends-a-new-approach-to-assess-cardiovascular-risk-and-reach-treatment-goals-for-lipid-levels

New guidance recommends a new approach to assess ...

The algorithms will allow clinicians to take a more precise approach to reducing cardiovascular risk in patients with high LDL cholesterol ...

6.

ctv.veeva.com

ctv.veeva.com/study/implementation-of-an-algorithm-and-multi-professional-team-supported-strategy-to-improve-lipid-mana

Implementation of an Algorithm- and Multi-professional Team ...

This is a randomized, controlled, collaborative, multicenter, pilot implementation science study evaluating the hypothesis that algorithm- and ...

7.

atherosclerosis-journal.com

atherosclerosis-journal.com/article/S0021-9150(25)01377-2/fulltext

2025 Focused Update of the 2019 ESC/EAS Guidelines for ...

Their presence may support reclassifying an individual to a higher risk category than would be calculated by the SCORE2 or SCORE2-OP algorithm, ...