Targeted lipid optimization program to improve LDL-C control in adults with ASCVD

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

This program will test whether a targeted education-based lipid optimization program helps adults with ASCVD and high LDL-C reach recommended LDL-C targets better than usual care.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 326 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Novartis (industry)
• Locations: 1 site (Abu Dhabi)
• Trial ID: NCT07034690 on ClinicalTrials.gov

What this trial studies

This open-label, randomized, pragmatic type I hybrid effectiveness-implementation trial enrolls adults with ASCVD who are at high or very high risk and already on maximum-tolerated statins. Participants are randomized to a targeted lipid optimization education program delivered via clinic visits every four months plus interim virtual sessions, or to standard care, and no active drug is provided. Primary outcomes focus on achieving guideline LDL-C thresholds, with secondary implementation measures such as adherence to the program and feasibility in routine practice. The trial is conducted at a Novartis investigative site in Abu Dhabi and requires participants to be able to view online educational materials.

Who should consider this trial

Good fit: Adults (≥18) with documented ASCVD who are classified as high or very high risk per guidelines, have LDL-C above the study thresholds while on maximum-tolerated statin therapy, are followed by a specialist, and can participate in online education.

Not a fit: Patients who cannot attend the Abu Dhabi clinic visits, cannot access or engage with online education, are not on optimized statin therapy, or whose LDL-C elevation is due to nonmodifiable causes may not receive benefit.

Why it matters

Potential benefit: If successful, the program could help more high-risk patients reach LDL-C targets and potentially reduce future cardiovascular events by improving clinician decision-making and patient adherence to lipid-lowering strategies.

How similar studies have performed: Previous educational and care-coordination programs for lipid management have shown variable but sometimes meaningful improvements in LDL-C control and medication adherence, although large pragmatic hybrid trials are less common.

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

Where this trial is running

Abu Dhabi

• Novartis Investigative Site — Abu Dhabi, United Arab Emirates (RECRUITING)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions: Atherosclerotic Cardiovascular Disease, Dyslipidemia,, ASCVD,, lipid optimization program,, LDL-C target,, educational intervention,, hybrid effectiveness-implementation study