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.
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
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.
Parallel
Educational Material
Other interventionHealth Education Intervention delivered via clinic visits (every 4 months) and virtual sessions (between each clinic visit)
Standard of care
Other interventionStandard of care
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
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
Change of LDL-C
Change of Low-Density Lipoprotein Cholesterol (LDL-C) from baseline at 12 months and 24 months in both study groups
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
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
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