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

Novartis

Status and phase: Not yet enrolling; Phase 4

Conditions: Atherosclerotic Cardiovascular Disease

Treatments: Other: Standard of care; Other: Educational Material

Study type: Interventional

Funder types: Industry

Identifiers

NCT07034690

CKJX839A1AE02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 326 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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326 participants in 2 patient groups

Intervention group

Other group

Description:

Participants receive Health Education Intervention alongside standard of care

Treatment:

Other: Educational Material

Other: Standard of care

Control Group

Other group

Description:

Participants receive Standard of care

Treatment:

Other: Standard of care