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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals

About this trial

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.

Eligibility criteria

Qualifiers

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)

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Educational Material
  • Standard of care

Treatment groups

326 Participants
are divided into 2 treatment groups

Sponsors and collaborators