500000 Participants Needed

Lipid Management Interventions for Cardiovascular Disease Risk

LE
SR
Overseen ByShalane R Basque, MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Institute for Clinical Evaluative Sciences
Must be taking: Statins
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of the drug Lipid management toolbox, Statin drugs, Cholesterol-lowering medications for cardiovascular disease risk?

Research shows that statins, a key part of this treatment, are effective in reducing the risk of heart-related problems and death. Adding ezetimibe to statins can further improve outcomes, especially for those with high cholesterol levels.12345

Is statin therapy generally safe for humans?

Statins, which are cholesterol-lowering medications, have been studied extensively and are generally well tolerated by most people. However, they can have side effects, particularly affecting muscles, liver, kidneys, and the nervous system, and some statins have been withdrawn from the market due to safety concerns.26789

How is the drug Lipid management toolbox different from other treatments for cardiovascular disease risk?

The Lipid management toolbox, primarily involving statins, is unique because it not only lowers cholesterol but also has additional benefits like reducing inflammation and improving blood vessel function, which can further decrease cardiovascular risk.210111213

What is the purpose of this trial?

Traditional randomized clinical trials (RCTs) have provided extremely valuable information on medical therapies and procedures that have changed the way heart diseases are treated. However, despite these contributions, traditional RCTs are costly, the findings may not be applicable to patients unlike those in the study, and the use of trial findings may be infrequent. These limitations may be addressed by incorporating 'big data' in RCTs, which is the emerging field using electronic information that is routinely collected in various large administrative health databases. The Community Heart Outcomes Improvement and Cholesterol Education Study (CHOICES) will test the potential of using 'big data' in a 'real-world' clinical trial to measure outcomes using routinely collected health information. CHOICES aims to increase the use of cholesterol-lowering statin drugs to prevent heart attack and stroke in high-risk health regions across Ontario using a 'toolbox' of interventions. The 'toolbox' of interventions are informational strategies targeted for both patients and family physicians to help improve cholesterol management and contribute to shared decision making for heart healthy goals.

Research Team

JA

Jacob A Udell, MD, MPH, FRCPC

Principal Investigator

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

MF

Michael Farkouh, MD, FRCPC, FACC, FAHA

Principal Investigator

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

Eligibility Criteria

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.
See 1 more

Exclusion Criteria

I have been diagnosed with cardiovascular disease.

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 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 ArmActive Control1 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:

πŸ‡ͺπŸ‡Ί
Approved in European Union as Statin drugs for:
  • Hypercholesterolemia
  • Prevention of cardiovascular events
πŸ‡ΊπŸ‡Έ
Approved in United States as Statin drugs for:
  • Hypercholesterolemia
  • Prevention of cardiovascular events
  • Primary prevention of coronary artery disease
πŸ‡¨πŸ‡¦
Approved in Canada as Statin drugs for:
  • Hypercholesterolemia
  • Prevention of cardiovascular events

Find a Clinic Near You

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+

Findings from Research

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.
Optimizing Statins and Ezetimibe in Guideline-Focused Management.Bin Abdulhak, AA., Robinson, JG.[2018]
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.
Statins.McLoughlin, C.[2007]
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.
Interventions to improve adherence to lipid-lowering medication.van Driel, ML., Morledge, MD., Ulep, R., et al.[2023]

References

Optimizing Statins and Ezetimibe in Guideline-Focused Management. [2018]
Statins. [2007]
Interventions to improve adherence to lipid-lowering medication. [2023]
Contemporary rates and correlates of statin use and adherence in nondiabetic adults with cardiovascular risk factors: The KP CHAMP study. [2021]
Proactive pharmaceutical care interventions improve patients' adherence to lipid-lowering medication. [2022]
Diagnosis, prevention, and management of statin adverse effects and intolerance: proceedings of a Canadian Working Group Consensus Conference. [2012]
The safety of HMG-CoA reductase inhibitors in special populations at high cardiovascular risk. [2019]
Statin safety: an overview and assessment of the data--2005. [2022]
Safety issues with statin therapy. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Pleiotropic effects of statins: moving beyond cholesterol control. [2019]
Suboptimal lipid management in patients with acute ischemic stroke. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
An overview of the clinical safety profile of atorvastatin (lipitor), a new HMG-CoA reductase inhibitor. [2019]
13.United Statespubmed.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. [2021]
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