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

NCT07034690 | Recruiting Phase 4

• 1 other identifier: CKJX839A1AE02
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atherosclerotic Cardiovascular Disease

Keywords

Dyslipidemia,; ASCVD,; lipid optimization program,; LDL-C target,; educational intervention,; hybrid effectiveness-implementation study

Outcome Measures

Primary Outcomes (1)

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

  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

  Baseline, month 12

Secondary Outcomes (14)

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

  Baseline, month 24

• Change of LDL-C

  Baseline, month 12 and month 24

• Change in the proportion of participants receiving advanced lipid lowering therapies

  Month 12 and Month 24

• Proportion of participants from the intervention group who complete all visits

  24 months

• Proportion of participants from the intervention group who discontinue the education program

  12 months

Study Arms (2)

Intervention group

OTHER

Participants receive Health Education Intervention alongside standard of care

Other: Educational Material; Other: Standard of care

Control Group

OTHER

Participants receive Standard of care

Other: Standard of care

Interventions

Standard of care OTHER

Standard of care

Control Group; Intervention group

Educational Material OTHER

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

Intervention group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Abu Dhabi, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Atherosclerosis; Dyslipidemias

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

novartis.email@novartis.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 24, 2025
• Study Start: November 26, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

AE (1)