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.

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 is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com