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

Phase 4RecruitingNCT07034690

Novartis Pharmaceuticals326 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

326

Conditions

Atherosclerotic Cardiovascular Disease

Interventions

Educational MaterialOTHER

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

Standard of careOTHER

Standard of care

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Investigative Site

Abu Dhabi, United Arab Emirates

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Baseline, month 12

Secondary Outcomes

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

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

Time frame: Baseline, month 24

Change of LDL-C

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

Time frame: Baseline, month 12 and month 24

Change in the proportion of participants receiving advanced lipid lowering therapies

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

Time frame: Month 12 and Month 24

Proportion of participants from the intervention group who complete all visits

Proportion of participants from the intervention group who complete all: * In clinic visits * Virtual sessions

Time frame: 24 months

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

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

Central Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

novartis.email@novartis.com

Data from ClinicalTrials.gov

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