Hypercholesterolaemia
Conditions
Interventions
Drug A: Placebo
The participants will receive placebo subcutaneous on top of HIS (+/- LLT) or non-statin LLT in statin intolerant participants.
Drug B: Inclisiran
The participants will receive Inclis
Sponsors
Maruyama Hideki
Eligibility
Sex/Gender
All
Inclusion criteria
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: - LDL-C >=70 mg/dL in participant previously treated with high-intensity statin (atorvastatin >=40 mg/day or rosuvastatin >=20 mg/day) or equivalent as per national guidelines and local regulation for at least 4 weeks before screening or - LDL-C >=100 mg/dL in participant previously treated with low/moderate-intensity statin for at least 4 weeks before screening or - LDL-C >=125 mg/dL in participant previously not treated with statins for at least 4 weeks before screening, or who never received statins (including statin intolerant participants). The participant must have a Baseline fasting LDL-C >=70 mg/dL (local lab assessment) to be eligible for randomization. Randomization within 7 days (=< 7 days) following hospital admission for the qualifying ACS event and before/at discharge.
Exclusion criteria
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: - Hemodynamic instability: hypotension, defined as sustained systolic blood pressure of 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 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. Renal insufficiency (eGFR 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 =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 protocol-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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in LDL-C | — |
Contacts
Public ContactHideki Maruyama
Novartis Pharma. K.K.
Outcome results
None listed