Study Description
This study is an open label, randomized, prospective, type I hybrid effectiveness- implementation, pragmatic clinical trial to evaluate the impact of a targeted lipid optimization program on LDL-C control in participants with dyslipidemia who are at high risk or very high risk of cardiovascular events. The treatment of interest is a lipid optimization program in the form of a health education intervention delivered via clinic visits (every 4 months) and virtual sessions (between each clinic visit).
No active drug treatment will be provided. The intervention in this study will involve the implementation of a lipid optimization, education program for patients at high risk and very high risk of cardiovascular events.
Interventions
Educational Material
Standard of care
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of ASCVD (coronary heart disease, peripheral arterial disease and/or cerebrovascular disease)
* High risk or very high risk for cardiovascular events (as per the 2019 ESC/EAS guidelines \[1\] for the management of dyslipidemias)
* Lipid levels:
* High risk: LDL-C ≥70 mg/dl (or \> 1.8 mmol/L) or non-HDL-C ≥100 mg/dl
* Very high risk: LDL-C ≥55 mg/dl (or \> 1.4 mmol/L) or non-HDL-C ≥85 mg/dl
* Male or Female
* 18 years or older
* Seen by a specialist who is prescribing advanced lipid lowering treatments (LLTs) (cardiologist, endocrinologist or any other relevant specialist)
* Currently taking maximum-tolerated statins
* Ability to participate in educational program (must be able to watch online videos)
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria:
* Any surgical or medical condition, which in the opinion of the Investigator, may place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study.
* Unwillingness or inability (e.g., physical or cognitive) to comply with study procedures (including adherence to study visits).
* Participation in any other interventional study.
* Inability to travel to study sites for in-person clinic visits.
* Responsible physician clinical decision not to engage the identified patient.
* Refusal of the potential participant to sign the consent and be included in the model.
Other protocol-defined inclusion/exclusion criteria may apply
Novartis Investigative Site
Recruiting
Abu Dhabi,United Arab Emirates
Worldwide Contacts
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