RecruitingPhase 4NCT07034690

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

A Prospective, Type I Hybrid Effectiveness-implementation, Open Label, Randomized Study to Evaluate the Impact of a Targeted Lipid Optimization Program on LDL-C Control in at- Risk Adult Patients From Abu Dhabi, United Arab Emirates (UAE) With Dyslipidemia

Sponsor

Novartis Pharmaceuticals

Enrollment

326 participants

Start Date

Nov 26, 2025

Study Type

INTERVENTIONAL

Conditions

Atherosclerotic Cardiovascular Disease

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria11

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
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 Criteria6

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.

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