The purpose of this trial is to learn about the effects of inclisiran in people with serious heart conditions (acute coronary syndromes), when this treatment is started early after hospital admission. To do this, researchers will test the effects of inclisiran compared to placebo, when given with standard treatment.
Signed informed consent must be obtained prior to participation in the study.
Males and females, ≥18 years of age at the time of providing written informed consent.
Ability to understand study's requirements and provide informed consent and comply with all required study procedures.
Hospitalization for a ACS event (STEMI or NSTEMI).
Hemodynamic instability: hypotension, defined as sustained systolic blood pressure of <90 mmHg due to cardiac failure with associated symptoms requiring inotropes
Sustained arrhythmic events such as: ventricular storm (e.g., torsade, ventricular tachycardia, ventricular flutter) not resolved before randomization
Cardiogenic shock or mechanical complication of myocardial infarction
New York Heart Association (NYHA) class IV heart failure
Parallel
Placebo
DrugThe participants will receive placebo subcutaneous at randomization (Day 1, Baseline visit) and Day 90
Inclisiran
DrugThe participants will receive Inclisiran sodium 300 mg subcutaneous at randomization (Day 1, Baseline visit) and Day 90
Percent change in LDL-C
To demonstrate the superiority of inclisiran treatment compared to placebo, when initiated before/at discharge, in combination with standard of care (SoC) (statin therapy +/- LLT (Lipid Lowering Therapy) or non-statin treatment in case of documented statin intolerance) on LDL-C reduction at Day 150
Participants achieving LDL-C <70 mg/dL (yes, no)
To assess the proportion of participants reaching pre-specified LDL-C target (\<70 mg/dL) on inclisiran treatment compared to placebo, on top of SoC
Participants achieving LDL-C <55 mg/dL (yes, no)
To assess the proportion of participants reaching pre-specified LDL-C target (\<55 mg/dL) on inclisiran treatment compared to placebo, on top of SoC
Participants achieving LDL-C <100 mg/dL (yes, no) (among the subset of participants with LDL-C ≥100 mg/dL at baseline)
To assess the proportion of participants reaching pre-specified LDL-C target (\<100 mg/dL) on inclisiran treatment compared to placebo, on top of SoC
Participants achieving ≥50% reduction from baseline in LDL-C (yes, no)
To assess the proportion of participants reaching pre-specified LDL-C target (≥50% reduction from baseline) on inclisiran treatment compared to placebo, on top of SoC
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