Study to Evaluate the Impact of a Targeted Lipid Optimization Program on LDL-C Control in At-risk Adult Patients With Dyslipidemia
Recruiting now · Phase 4
Conditions studied: Atherosclerotic Cardiovascular Disease
In brief
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.
Key facts
- Study ID
- NCT07034690
- Run by
- Novartis Pharmaceuticals
- People needed
- 326
- Starts
- 2025-11-26
- Expected to finish
- 2028-05-31
- Last updated by the study team
- 2026-05-04
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Novartis Investigative Site — Abu Dhabi, United Arab Emirates (enrolling)
Full record on ClinicalTrials.gov
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