Study to Evaluate the Impact of a Targeted Lipid Optimization Program on LDL-C Control in At-risk Adult Patients With Dyslipidemia

Launched by NOVARTIS PHARMACEUTICALS · Jun 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a special program designed to help people with certain heart and blood vessel diseases better control their “bad” cholesterol, known as LDL cholesterol. The goal is to see if this targeted program can improve cholesterol levels in adults who are at high or very high risk of heart problems, despite already taking strong cholesterol-lowering medicines called statins.

People who might join this study are adults aged 18 or older who have conditions like heart disease, blocked arteries, or stroke, and whose cholesterol levels remain higher than recommended even with current treatment. Participants will be those already seeing a heart or hormone specialist and able to take part in an educational program that includes watching videos online. Throughout the study, participants will be closely monitored to see how well their cholesterol improves with the program. This study is not yet open for enrollment, but if eligible, participants can expect support aimed at helping better manage their cholesterol to lower their risk of future heart issues.

Gender

ALL

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