This study aims to evaluate the effectiveness and safety of implementing a systematic augmented low-density lipoprotein cholesterol (LDL-C) management care pathway initiated in hospitals for patients with Acute Coronary Syndrome. This pathway includes treatment with inclisiran on top of the standard of care (SOC), which consists of statins with or without ezetimibe, compared to a high-intensity SOC regimen alone (statins +/- ezetimibe).
Males and females ≥18 years of age.
Recent ACS (in-patient/out-patient) within 7 days of index admission, as per 2023 ESC guidelines for the management of acute coronary syndrome
Serum LDL-C ≥1.8 mmol/L (≥70 mg/dL) or non-HDL ≥100 mg/dL at screening for participants who were receiving SOC [including lipid lowering therapy and/or ezetimibe] prior enrollment.
Serum LDL-C ≥2.6 mmol/L (≥100 mg/dL) or non-HDL ≥124 mg/dL at screening for participants who were SOC treatment naïve prior enrollment.
Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study and/or put the participant at significant risk (according to investigator's [or delegate] judgment) if he/she participates in the clinical study.
An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.
New York Heart Association (NYHA) class IIIb or IV heart failure or last known left ventricular ejection fraction <25%.
Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening.
Parallel
inclisiran
DrugInclisiran sodium 300 mg
SOC
Drugconsists of statins with or without ezetimibe, compared to a high-intensity SOC regimen alone (statins +/- ezetimibe)
Percent change in LDL-C from baseline at Day 60
Difference in percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) between inclisiran + SOC group and SOC alone group
Absolute change from baseline in LDL-C levels
Absolute change from baseline in LDL-C levels in the inclisiran + SOC group compared to SOC group at Days 14, 30, 60, 90 in phase 1 and Day 150 in all participants in phase 2
Average percent change from baseline in LDL-C levels
Average percent change from baseline in LDL-C levels in the inclisiran + SOC group compared to SOC group at Days 14, 30, 60, 90 in phase 1 and Day 150 in all participants in phase 2.
Average absolute change from baseline in LDL-C levels
Average absolute change from baseline in LDL-C levels in the inclisiran + SOC group compared to SOC group at Days 14, 30, 60, 90 in phase 1 and Day 150 in all participants in phase 2.
Proportion of participants achieving LDL-C levels <1.4 mmol/L
Proportion of participants achieving LDL-C levels \<1.4 mmol/L in each treatment group (inclisiran + SOC vs. SOC alone) at Days 30, 60, 90 in phase 1 and Day 150 in all participants in phase 2.
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