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Recruiting NCT07034690

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

Phase IV Interventional Atherosclerotic Cardiovascular Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Educational Material, Standard of care.
Who it may be relevant to
Registry conditions: Atherosclerotic Cardiovascular Disease. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Arab Emirates
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Detailed description

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.

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

Primary outcome measures

  • Percentage of participants achieving target LDL-C goals based on CV risk [Time frame: Baseline, month 12]
Secondary outcome measures (12)
  • Percentage of participants achieving or maintaining target LDL-C goals based on CV risk [Time frame: Baseline, month 24]
  • Change of LDL-C [Time frame: Baseline, month 12 and month 24]
  • Change in the proportion of participants receiving advanced lipid lowering therapies [Time frame: Month 12 and Month 24]
  • Proportion of participants from the intervention group who complete all visits [Time frame: 24 months]
  • Proportion of participants from the intervention group who discontinue the education program [Time frame: 12 months]
  • Proportion of days covered [Time frame: Baseline, month 12 and month 24]
  • Number of hospitalizations [Time frame: 24 months]
  • Number of outpatient visits [Time frame: 24 months]
  • Number of ER visits [Time frame: 24 months]
  • Associated costs [Time frame: 24 months]
  • Number of LDL-C tests performed [Time frame: 24 months]
  • Change in knowledge awareness scores: [Time frame: Baseline, month 12 and month 24]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United Arab Emirates · 1 center
  • Novartis Investigative Site — Abu Dhabi

Identifiers

NCT: NCT07034690 · CKJX839A1AE02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗