Lipid Management Interventions for Cardiovascular Disease Risk
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?
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have side effects, particularly affecting muscles, liver, kidneys, and the nervous system, and some statins have been withdrawn from the market due to safety concerns.26789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?
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
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Implementation of a multicomponent intervention strategy using a 'toolbox' of lipid management resources for patients and physicians in high-risk communities
Follow-up
Participants are monitored for safety and effectiveness after intervention, focusing on statin prescription fills and adherence
Treatment Details
Interventions
- Lipid management toolbox
Lipid management toolbox is already approved in European Union, United States, Canada for the following indications:
- Hypercholesterolemia
- Prevention of cardiovascular events
- Hypercholesterolemia
- Prevention of cardiovascular events
- Primary prevention of coronary artery disease
- Hypercholesterolemia
- Prevention of cardiovascular events
Find a Clinic Near You
Who Is Running the Clinical Trial?
Institute for Clinical Evaluative Sciences
Lead Sponsor
Heart and Stroke Foundation of Ontario
Collaborator
Heart & Stroke Richard Lewar Centres of Excellence in Cardiovascular Research
Collaborator
The Ontario Spor Support Unit
Collaborator
CorHealth Ontario
Collaborator
Knowledge Translation Program of St. Michael's Hospital
Collaborator
Knowledge Translation Program at St. Michael's Hospital
Collaborator
The Heart and Stroke Foundation
Collaborator
Heart and Stroke Richard Lewar Centres of Excellence in Cardiovascular Research
Collaborator