Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome

Inclusion Criteria:

• Recent Acute Coronary Syndrome (in-patient/out-patient) within 5 weeks of screening

• Serum LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL

• Fasting triglycerides <4.52 mmol/L (<400 mg/dL) at screening

• Calculated glomerular filtration rate >20 mL/min by estimated glomerular filtrationrate (eGFR)

• Participants are required to be discharged on statin therapy, or have documentedstatin intolerance, as determined by the investigator, following hospitalization foran ACS. Statin intolerant participants are eligible if they had intolerable sideeffects on at least 2 different statins, including one at the lowest standard dose

Exclusion Criteria:

• New York Heart Association (NYHA) class IIIb or IV heart failure or last known leftventricular ejection fraction <25%.

• Significant cardiac arrhythmia within 3 months prior to randomization that is notcontrolled by medication or via ablation at the time of screening.

• Severe concomitant non-cardiovascular disease that carries the risk of reducing lifeexpectancy to less than 2 years.

• Treatment with other investigational products or devices within 30 days or fivehalf˗lives of the screening visit, whichever is longer.

• Planned use of other investigational products or devices during the course of thestudy.

• Treatment with monoclonal antibodies directed towards PCSK9 within 90 days ofscreening.

• Recurrent ACS event within 2 weeks prior to randomization.

• Coronary angiography and revascularization procedure (percutaneous coronaryintervention (PCI) or coronary artery bypass grafting (CABG) surgery) performedwithin 2 weeks prior to the randomization visit or planned after randomization.