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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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).
✓. Receiving treatment for the qualifying ACS event, according to clinical judgement, by means of medical treatment alone or percutaneous coronary revascularization.
✓. Had a successful PCI (with or without stent) for the qualifying event if a PCI was required.
✓. LDL-C value at the Screening visit measured by the local lab of:
✓. The participant must have a Baseline fasting LDL-C ≥70 mg/dL (local lab assessment) to be eligible for randomization.
Exclusion criteria
✕. Participant who is clinically unstable during hospitalization for the qualifying ACS event, defined by any of the following events within 24 hours prior to randomization:
✕. Participant who has undergone or is scheduled to undergo CABG for treatment of the qualifying ACS event.
✕. Active liver disease defined as: (i) any known current infectious, neoplastic, or metabolic pathology of the liver or (ii) alanine aminotransferase (ALT) elevation \>3x ULN or aspartate aminotransferase (AST) elevation \>3x ULN, or total bilirubin elevation \>2x ULN (except participant with Gilbert's syndrome) at the Screening visit, in the context of an ACS, and assessed as related to the index event and/or treatment procedures (such as PCI). Eligibility will be based on Investigator's judgement for participant who will be randomized.