Last Update: Jan 30, 2026
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:CKJX839A1AE02
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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.

Atherosclerotic Cardiovascular Disease
Phase4
Recruiting
326
Nov 26, 2025
Jun 30, 2027
All
18 Years - 100 Years (Adult, Older Adult)

Interventions

Other

Educational Material

Health Education Intervention delivered via clinic visits (every 4 months) and virtual sessions (between each clinic visit)
Other

Standard of care

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

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

Novartis Pharmaceuticals

-