Testing Inclisiran against a placebo for acute coronary syndrome

Exclusion

• −Participant meeting any of the following criteria is not eligible for inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → in this study.
• −Only for Japan: For exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → 6, investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → judgment should be documented in the source data document.
• −Participant who is clinically unstable during hospitalization for the qualifying ACS event, defined by any of the following events within 24 hours prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →:
• −Hemodynamic instability: hypotension, defined as sustained systolic blood pressure of \<90 mmHg due to cardiac failure with associated symptoms requiring inotropes
• −Arrhythmic events: Ventricular storm (e.g., torsade, ventricular tachycardia, ventricular flutter)
• −Cardiogenic shock or mechanical complication of myocardial infarction
• −New York Heart Association (NYHA) class IV heart failure
• −Left ventricular ejection fraction \<20% at randomization (after all treatment procedures, based on the latest assessment of the LVEF using invasive or non-invasive assessment modalities)
• −Uncontrolled severe hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg prior to randomization despite antihypertensive therapy.
• −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 visitScreeningThe checks done before joining, to see whether a study fits.Read more →, in the context of an ACS, and assessed as related to the index event and/or treatment procedures (such as PCI). EligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → will be based on Investigator's judgement for participant who will be randomized.
• −Renal insufficiency (eGFR \<30 mL/min/1.73m2) at the Screening visit.
• −Fasting triglycerides value \>400 mg/dL (4.52 mmol/L; assessed by local labs) at randomization visit.
• −Participant, who based on the Investigator's judgement, could reach the LDL-C target value of \<55 mg/dL after 4 weeks on statin treatment only.
• −Secondary hypercholesterolemia (based on medical history).
• −Homozygous familial hypercholesterolemia (based on medical history).
• −Participant on apheresis at the Screening visit.
• −Ongoing or medical history of myopathy at the Screening visit.
• −CK values ≥5x ULN at Screening visit and confirmed by repeat test during Screening (local lab) , 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 (who will be switched to or initiated on the protocolProtocolThe detailed plan a study must follow.Read more →-specified dose of high-intensity statin of atorvastatin ≥40 mg QD or rosuvastatin ≥20 mg QD). Unless a more stringent CK value threshold is mandated by a local regulatory authority (e.g., ≥3x ULN in Korea according to MFDS internal guideline).