Lipid Management Interventions for Cardiovascular Disease Risk
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Institute for Clinical Evaluative Sciences
Must be taking: Statins
Disqualifiers: Established CVD
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
26789How 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.
210111213Eligibility 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.
+1 more
Exclusion Criteria
I have been diagnosed with cardiovascular disease.
Trial 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
Participant Groups
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.
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:
🇪🇺 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
ICESToronto, Canada
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Who Is Running the Clinical Trial?
Institute for Clinical Evaluative SciencesLead Sponsor
Heart and Stroke Foundation of OntarioCollaborator
Heart & Stroke Richard Lewar Centres of Excellence in Cardiovascular ResearchCollaborator
The Ontario Spor Support UnitCollaborator
CorHealth OntarioCollaborator
Knowledge Translation Program of St. Michael's HospitalCollaborator
Knowledge Translation Program at St. Michael's HospitalCollaborator
The Heart and Stroke FoundationCollaborator
Heart and Stroke Richard Lewar Centres of Excellence in Cardiovascular ResearchCollaborator
References
Optimizing Statins and Ezetimibe in Guideline-Focused Management. [2018]Statins are essential medications in the management of patients with clinical atherosclerotic cardiovascular disease, and have been supported by numerous clinical trials. Emerging evidence suggests that adding ezetimibe to statin therapy is associated with a net benefit and improved hard clinical outcomes, particularly in patients with significantly elevated atherosclerotic cardiovascular disease risk and elevated low-density lipoprotein cholesterol levels.
Statins. [2007]Statins are a lipid-lowering medication. They are increasingly being used for the primary and secondary prevention of cardiovascular disease, as a growing body of research shows that they reduce mortality rates. Carol McLoughlin explains how they work, discusses contraindications, and offers advice on educating patients in their use.
Interventions to improve adherence to lipid-lowering medication. [2023]Lipid-lowering drugs are widely underused, despite strong evidence indicating they improve cardiovascular end points. Poor patient adherence to a medication regimen can affect the success of lipid-lowering treatment.
Contemporary rates and correlates of statin use and adherence in nondiabetic adults with cardiovascular risk factors: The KP CHAMP study. [2021]Statin therapy is highly efficacious in the prevention of fatal and nonfatal atherosclerotic events in persons at increased cardiovascular risk. However, its long-term effectiveness in practice depends on a high level of medication adherence by patients.
Proactive pharmaceutical care interventions improve patients' adherence to lipid-lowering medication. [2022]Lipid-lowering drugs are effective preventive medication for patients at risk of cardiovascular complications. However, medication adherence is suboptimal, thereby decreasing therapy effectiveness. Pharmaceutical care interventions may increase therapy adherence.
Diagnosis, prevention, and management of statin adverse effects and intolerance: proceedings of a Canadian Working Group Consensus Conference. [2012]While the proportion of patients with significant statin-associated adverse effects or intolerance is very low, the increasing use and broadening indications have led to a significant absolute number of such patients commonly referred to tertiary care facilities and specialists. This report provides a comprehensive overview of the evidence pertaining to a broad variety of statin-associated adverse effects followed by a consensus approach for the prevention, assessment, diagnosis, and management. The overview is intended both to provide clarification of the untoward effects of statins and to impart confidence in managing the most common issues in a fashion that avoids excessive ancillary testing and/or subspecialty referral except when truly necessary. The ultimate goal is to ensure that patients who warrant cardiovascular risk reduction can be treated optimally, safely, and confidently with statin medications or alternatives when warranted.
The safety of HMG-CoA reductase inhibitors in special populations at high cardiovascular risk. [2019]Controlled clinical studies and clinical experience over many years have proven that virtually all patients benefit from lipid-lowering therapy with statins, even those with normal LDL cholesterol levels. Several recent large outcome trials have further demonstrated the clinical benefits and safety of statins in patients with a wide-range of high risks for cardiovascular disease. Those patients at highest absolute cardiovascular risk generally have the most to gain from statin therapy. A variety of statins are available to lower plasma lipids to guideline levels, but all differ in their pharmacokinetic properties, drug interaction profiles, and risk of myotoxicity. This has been highlighted by the withdrawal of cerivastatin from the market as a result of serious safety concerns. This review examines the safety and effectiveness of statins in special populations at high risk of cardiovascular disease-patients with coronary heart disease, dyslipidaemia, diabetes, hypertension, nephrotic disease, HIV, organ transplant patients and the elderly-with a focus on clinically relevant differences in the properties of individual statins that may influence the risk of drug interactions and side effects.
Statin safety: an overview and assessment of the data--2005. [2022]The 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, or statin drugs, have been studied in numerous controlled human research trials involving hundreds of thousands of study participants. Statins have been prescribed for millions of patients. Based on this vast research and clinical experience, statins have been shown to improve lipid blood levels and reduce atherosclerotic coronary artery disease (CAD) risk, resulting in reduced CAD morbidity and mortality, and in several studies, reduced overall ("all-cause") mortality. From a safety perspective, both research trial evidence and clinical practice experience have demonstrated that statins are generally well tolerated. However, as with all pharmaceuticals, safety considerations exist with both monotherapy and combination statin therapy, mainly involving potential adverse effects on muscle, liver, kidney, and the nervous system. The evidence supporting statin-related potential adverse experiences on these organ systems is sometimes strong and based on clear clinical trial evidence (such as the increased risk of muscle enzyme elevation with higher statin doses). The evidence is at other times more speculative, being based on case reports and inconclusive clinical trial data (such as possible favorable or unfavorable effects of statins on cognition). Because the use of statins is so widespread, it is useful for the clinician to understand statin safety issues and the level of available evidence supporting the contention that various adverse effects are caused by statins. This review presents an assessment of statin safety based on an overview of the current statin safety data and their clinical implications.
Safety issues with statin therapy. [2019]To describe the most important potential adverse effects related to statin therapy, discuss mechanisms of toxicity and drug interactions, and suggest approaches for enhancing safety with statin therapy.
Pleiotropic effects of statins: moving beyond cholesterol control. [2019]3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors or "statin" medications are the most commonly prescribed therapy for lowering cholesterol. In use for over a decade, they have demonstrated both safety and tolerability across a broad range of patients. The ability to inhibit the biosynthesis of cholesterol and reduce low-density lipoprotein cholesterol levels is known to play a major part in reducing cardiovascular risk. Multiple clinical trials have cemented their role in both primary and secondary prevention of atherosclerotic disease. Clinical evidence also supports the principle that reductions in cardiovascular risk are interdependent on mechanisms beyond cholesterol reduction alone. These pleiotropic effects of statins have underscored a widening focus and understanding into the mechanisms of vascular dysfunction, inflammation, and injury. They have also brought a new perspective to a broad spectrum of clinical uses that has implications for specialties as varied as infectious disease, rheumatology, and oncology.
Suboptimal lipid management in patients with acute ischemic stroke. [2023]Lipid-lowering drugs are among the most widely used drugs in cardiovascular prevention. Statins are often abandoned due to side effects, or under dosed, leading to unreached LDL-cholesterol goals and increased occurrence of cardiovascular events.
An overview of the clinical safety profile of atorvastatin (lipitor), a new HMG-CoA reductase inhibitor. [2019]Statins (3-hydroxy-3-methylglutaryl-coenzyme A [HMG-CoA] reductase inhibitors) have been used for a decade to lower low-density lipoprotein (LDL) cholesterol levels and to improve cardiovascular disease and clinical outcomes.
Effectiveness of Interventions Aimed at Increasing Statin-Prescribing Rates in Primary Cardiovascular Disease Prevention: A Systematic Review of Randomized Clinical Trials. [2021]Statins are a cornerstone medication in cardiovascular disease prevention, but their use in clinical practice remains suboptimal, with less than half of people who are indicated for statins actually taking the medication.