Lipid Management Interventions for Cardiovascular Disease Risk

Overseen By Shalane R Basque, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Institute for Clinical Evaluative Sciences

Must be taking: Statins

Disqualifiers: Established CVD

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if big data (large sets of information collected over time) can improve the use of cholesterol-lowering statin medications to prevent heart attacks and strokes. The focus is on high-risk areas in Ontario, where communities will either receive new cholesterol management resources (the "lipid management toolbox") or continue with standard care. The trial seeks communities with higher-than-average heart disease rates, large populations of adults aged 40 to 75, and active family doctors. Residents of such communities who have not been diagnosed with heart disease might be suitable participants.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance heart health management in these communities.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It focuses on increasing the use of cholesterol-lowering statin drugs, so you may be able to continue your current medications, but it's best to confirm with the trial coordinators.

What prior data suggests that the lipid management toolbox is safe for cardiovascular disease risk management?

Research has shown that cholesterol-lowering drugs, such as statins, are generally safe and easy for most people to take. Studies have found that statins can lower bad cholesterol (LDL-C) and reduce the risk of heart attacks and strokes. One large review of statin studies found that these drugs help lower the risk of major heart problems.

While some side effects may occur, they are usually mild, such as muscle pain or digestive issues. Most people do not experience serious problems. Statins have been used for many years, providing substantial evidence of their safety in managing cholesterol and reducing the risk of heart disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the lipid management toolbox because it offers a comprehensive, scalable approach to managing cardiovascular disease (CVD) risk. Unlike standard treatments that focus on individual medications or lifestyle changes, this toolbox integrates multiple evidence-based interventions accessible to both doctors and patients. By utilizing online tools and existing communication channels like newsletters and listservs, it enhances accessibility and minimizes costs, making it easier to reach a wider population. This innovative approach aims to optimize lipid levels effectively by empowering communities with practical and scalable resources.

What evidence suggests that this trial's treatments could be effective for cardiovascular disease risk?

Research has shown that statin therapy, a crucial tool for managing cholesterol, effectively reduces heart-related problems. Studies have found that lowering "bad" cholesterol (LDL-C) by 1 mmol/l can decrease heart disease events by about 23%. One study found that taking 10 mg of rosuvastatin, a type of statin, reduced heart problems by 24% in people at moderate risk. Statins are recommended as the first step for those at higher risk of heart disease, as they help lower cholesterol and prevent heart attacks and strokes. These findings support using statins to manage heart disease risk. In this trial, the intervention arm will receive a multicomponent intervention that includes access to a 'toolbox' of lipid management resources, incorporating evidence-based interventions like statin therapy. ^{2 6 7 8 9}

Who Is on the Research Team?

Jacob A Udell, MD, MPH, FRCPC

Principal Investigator

ICES; Women's College Hospital; Peter Munk Cardiac Centre, Toronto General Hospital; University of Toronto

Michael Farkouh, MD, FRCPC, FACC, FAHA

Principal Investigator

Peter Munk Cardiac Centre, Toronto General Hospital; University of Toronto

Are You a Good Fit for This Trial?

This trial is for communities in Ontario with higher-than-average cardiovascular disease rates, a certain number of family physicians, and specific population sizes of adults aged 40-75. It's not for patients who already have established heart conditions.

Inclusion Criteria

I live in a community with high heart disease rates.

The area has between 20 and 130 family doctors who are currently working.

I live in a community with more than 5,000 people aged 40 to 75.

Exclusion Criteria

I have been diagnosed with cardiovascular disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of a multicomponent intervention strategy using a 'toolbox' of lipid management resources for patients and physicians in high-risk communities

3 years

Ongoing community-based interventions

Follow-up

Participants are monitored for safety and effectiveness after intervention, focusing on statin prescription fills and adherence

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Lipid management toolbox

Trial Overview

The CHOICES study is testing how 'big data' can be used in clinical trials to improve cholesterol management using a toolbox of informational strategies aimed at both doctors and patients to prevent heart attacks and strokes.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

The 14 communities that are in the intervention arm of the trial will receive a multicomponent intervention that provides both physicians and patients with access to a 'toolbox' of lipid management resources. The components planned for the 'toolbox' are all evidence-based interventions and chosen after consultations with Canadian family physicians and implementation science experts based on their potential for scalability to the entire population, cost and practicality. Online tools will be used and the trial will leverage pre-existing implementation initiatives (e.g., newsletters, listservs) wherever possible to minimize study costs and increase accessibility.

Group II: Control Arm Active Control 1 Intervention

The 14 communities that are in the control arm of the trial will receive usual standard of care. The usual standard of care will follow clinical daily practice patterns provided by family physicians in Ontario for CVD prevention. This follows the periodic standard of care provided by Canadian cholesterol, hypertension, and diabetes best practice guideline recommendations utilized based on each physician's clinical judgement, physical assessment, and discretion. Patients also typically have access to existing cardiovascular prevention materials offered online through publicly available websites.

Lipid management toolbox is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Statin drugs for:

• Hypercholesterolemia
• Prevention of cardiovascular events

Approved in United States as Statin drugs for:

• Hypercholesterolemia
• Prevention of cardiovascular events
• Primary prevention of coronary artery disease

Approved in Canada as Statin drugs for:

• Hypercholesterolemia
• Prevention of cardiovascular events

Who Is Running the Clinical Trial?

Institute for Clinical Evaluative Sciences

Lead Sponsor

Trials

37

Recruited

2,509,000+

Heart and Stroke Foundation of Ontario

Collaborator

Trials

67

Recruited

832,000+

Heart & Stroke Richard Lewar Centres of Excellence in Cardiovascular Research

Collaborator

Trials

1

Recruited

500,000+

The Ontario Spor Support Unit

Collaborator

Trials

6

Recruited

508,000+

CorHealth Ontario

Collaborator

Trials

2

Recruited

500,000+

Knowledge Translation Program of St. Michael's Hospital

Collaborator

Trials

1

Recruited

500,000+

Knowledge Translation Program at St. Michael's Hospital

Collaborator

Trials

1

Recruited

500,000+

The Heart and Stroke Foundation

Collaborator

Trials

1

Recruited

500,000+

Heart and Stroke Richard Lewar Centres of Excellence in Cardiovascular Research

Collaborator

Trials

1

Recruited

500,000+

Published Research Related to This Trial

Statins, which are widely prescribed for lowering cholesterol, have been proven safe and effective in reducing cardiovascular risk through their ability to inhibit cholesterol biosynthesis and lower LDL cholesterol levels.

Beyond just lowering cholesterol, statins exhibit pleiotropic effects that may help in managing vascular dysfunction and inflammation, suggesting potential benefits in various medical fields beyond cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pleiotropic effects of statins: moving beyond cholesterol control. Garcia, PJ.[2019]

Although statin-associated adverse effects are rare, their increasing use has led to a notable number of patients experiencing these issues, necessitating referrals to specialists.

This report offers a consensus approach for effectively managing statin-related side effects, aiming to optimize treatment for patients needing cardiovascular risk reduction while minimizing unnecessary testing and referrals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis, prevention, and management of statin adverse effects and intolerance: proceedings of a Canadian Working Group Consensus Conference. Mancini, GB., Baker, S., Bergeron, J., et al.[2012]

Statins have been proven effective in improving lipid levels and significantly reducing the risk of atherosclerotic coronary artery disease (CAD), which leads to lower morbidity and mortality rates associated with CAD.

While statins are generally well tolerated, there are safety concerns regarding potential adverse effects on muscles, liver, kidneys, and the nervous system, with some risks being well-documented and others remaining speculative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statin safety: an overview and assessment of the data--2005. Bays, H.[2022]

Statin therapy can lead to adverse effects, primarily hepatotoxicity and myopathy, but serious liver dysfunction is rare and usually reversible with dose adjustments.

Despite potential risks, the benefits of statins in preventing cardiovascular disease outweigh these risks, especially when considering safer options for vulnerable populations like the elderly or those on multiple medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety issues with statin therapy. Talbert, RL.[2019]

Atorvastatin, evaluated in 21 completed and 23 ongoing clinical trials with a total of 4271 patients, demonstrated a favorable safety profile, with fewer than 2% of patients withdrawing due to adverse events.

The most common side effects were mild, including constipation and abdominal pain, and serious adverse events were rare, with only 0.7% of patients experiencing significant liver enzyme elevations, indicating atorvastatin is well-tolerated compared to other statins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview of the clinical safety profile of atorvastatin (lipitor), a new HMG-CoA reductase inhibitor. Black, DM., Bakker-Arkema, RG., Nawrocki, JW.[2019]

Intensified patient care interventions, such as electronic reminders and pharmacist-led support, significantly improve adherence to lipid-lowering medications, with a moderate-quality evidence showing nearly double the adherence rates compared to usual care in over 11,000 participants.

These interventions not only enhance adherence but also lead to meaningful reductions in total cholesterol and LDL-cholesterol levels, indicating their effectiveness in managing lipid levels over both short and long-term periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to improve adherence to lipid-lowering medication. van Driel, ML., Morledge, MD., Ulep, R., et al.[2023]

Statins are effective lipid-lowering medications that help prevent cardiovascular disease and have been shown to reduce mortality rates.

Understanding how statins work and their contraindications is crucial for educating patients on their safe and effective use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statins. McLoughlin, C.[2007]

Statins are beneficial for nearly all patients, including those with normal LDL cholesterol levels, and recent trials confirm their safety and effectiveness in high-risk cardiovascular patients.

Different statins have varying properties that affect their safety and efficacy, particularly in special populations such as the elderly and those with conditions like diabetes or organ transplants, highlighting the importance of choosing the right statin to minimize side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of HMG-CoA reductase inhibitors in special populations at high cardiovascular risk. Corsini, A.[2019]

A systematic review of 20 studies involving 109,807 patients found that various interventions can significantly increase statin-prescribing rates, with patient-education initiatives being the most effective.

Tailored interventions that provide personalized cardiovascular risk information and dynamic decision-support tools were more successful than generic physician education, highlighting the importance of targeted approaches in improving medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Interventions Aimed at Increasing Statin-Prescribing Rates in Primary Cardiovascular Disease Prevention: A Systematic Review of Randomized Clinical Trials. Sparrow, RT., Khan, AM., Ferreira-Legere, LE., et al.[2021]

Statins are crucial for treating patients with atherosclerotic cardiovascular disease, backed by extensive clinical trial evidence.

Adding ezetimibe to statin therapy can enhance patient outcomes, especially for those at high risk with elevated LDL cholesterol levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Statins and Ezetimibe in Guideline-Focused Management. Bin Abdulhak, AA., Robinson, JG.[2018]

In a study of 92 hospitalized patients with ischemic stroke or transient ischemic attack, 75 patients had poorly managed LDL-cholesterol levels despite many being on lipid-lowering therapy, highlighting a gap in effective treatment.

Only 8 out of 21 patients on high-intensity lipid-lowering therapy achieved their LDL-C targets, indicating a need for better optimization of lipid management to meet international guidelines for stroke prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suboptimal lipid management in patients with acute ischemic stroke. Vandewalle, L., Duchi, F., Verhelle, K., et al.[2023]

A proactive pharmaceutical care intervention program called Medication Monitoring and Optimization (MeMO) significantly reduced therapy discontinuation rates for lipid-lowering drugs, with only 13.6% discontinuation in the intervention group compared to 25.9% in the usual care group, indicating a 51% lower risk of discontinuation.

Patient satisfaction with the MeMO program was very high, highlighting the importance of pharmacists in providing medication information and support, which can enhance adherence and potentially lower healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proactive pharmaceutical care interventions improve patients' adherence to lipid-lowering medication. Stuurman-Bieze, AG., Hiddink, EG., van Boven, JF., et al.[2022]

In a study of 209,704 nondiabetic adults with cardiovascular risk factors, 32.5% initiated statin therapy, but only 42% maintained consistent treatment after 12 months, highlighting a significant gap in medication adherence.

Certain groups, such as older adults and those with a history of heart issues, were more likely to continue their statin therapy, suggesting targeted interventions could improve adherence among at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemporary rates and correlates of statin use and adherence in nondiabetic adults with cardiovascular risk factors: The KP CHAMP study. Go, AS., Fan, D., Sung, SH., et al.[2021]

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