Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07034690

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Atherosclerotic Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site

Abu Dhabi, United Arab Emirates

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

educational material

Other

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

Standard of care

Other

Standard of care

Primary outcomes

  1. Percentage of participants achieving target LDL-C goals based on CV risk

    Time frame: Baseline, month 12

    Percentage of participants achieving target Low-Density Lipoprotein Cholesterol (LDL-C) goals based on Cardiovascular (CV) risk stratified by group:

    • Very high risk: <55 mg/dl
    • High risk: <70 mg/dl

Secondary outcomes

  1. Percentage of participants achieving or maintaining target LDL-C goals based on CV risk

    Time frame: Baseline, month 24

    Percentage of participants achieving or maintaining target Low-Density Lipoprotein Cholesterol (LDL-C) goals based on Cardiovascular (CV) risk stratified by group:

    • Very high risk: <55 mg/dl
    • High risk: <70 mg/dl

  2. Change of LDL-C

    Time frame: Baseline, month 12 and month 24

    Change of Low-Density Lipoprotein Cholesterol (LDL-C) from baseline at 12 months and 24 months in both study groups

  3. Change in the proportion of participants receiving advanced lipid lowering therapies

    Time frame: Month 12 and Month 24

    Change in the proportion of participants receiving advanced lipid lowering therapies at 12 months and 24 months from baseline, for each group

  4. Proportion of participants from the intervention group who complete all visits

    Time frame: 24 months

    Proportion of participants from the intervention group who complete all:

    • In clinic visits
    • Virtual sessions

  5. Proportion of participants from the intervention group who discontinue the education program

    Time frame: 12 months

    Proportion of participants from the intervention group who discontinue the education program before the 12 month study visit

  6. Proportion of days covered

    Time frame: Baseline, month 12 and month 24

    Proportion of days covered (for statins and non-statin lipid therapies)

  7. Number of hospitalizations

    Time frame: 24 months

    Number of hospitalizations during the 12 month active intervention period and the 12 month follow up period

  8. Number of outpatient visits

    Time frame: 24 months

    Number of outpatient visits during the 12 month active intervention period and the 12 month follow up period

  9. Number of ER visits

    Time frame: 24 months

    Number of Emergency Room (ER) visits during the 12 month active intervention period and the 12 month follow up period

  10. Associated costs

    Time frame: 24 months

    Associated costs during the 12 month active intervention period and the 12 month follow up period

  11. Number of LDL-C tests performed

    Time frame: 24 months

    Number of Low-Density Lipoprotein Cholesterol (LDL-C) tests performed, analyzed according to:

    • Site (clinic)
    • Healthcare Professional (HCP) specialty (Cardiologists, Endocrinologists, internist, etc.)
    • Baseline characteristics (e.g. age, sex, ethnicity, Cardiovascular risk status)

  12. Change in knowledge awareness scores:

    Time frame: Baseline, month 12 and month 24

    Awareness regarding lipid management amongst those participants in the intervention group will be measured using a knowledge awareness questionnaire. The same questionnaire will be administered at baseline, 12 months and 24 months, enabling scores to be compared across the study duration.

    The knowledge awareness questionnaire scale has a minimum score of 0 and maximum score of 17 points. A high score will indicate higher participant awareness.

  13. Change in WHO BREF quality of life scores

    Time frame: Baseline, month 12 and month 24

    WHO BREF questionnaire assesses QoL across four main domains: physical health, psychological health, social relationships, and environmental health.

    Participants will respond to each item using a Likert scale (ranging from 1 to 5) indicating their level of agreement or satisfaction. Higher scores typically indicate better QoL.

  14. Qualitative surveys among focus groups of HCPs and participants to evaluate implementation outcomes

    Time frame: month 12 and month 24

    Implementability of the lipid optimization program will be assessed during focus group sessions that explore satisfaction, costs, and acceptance of the program from the perspective of HCPs and participants

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: OPTIMA

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 24, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.