INCLISIRAN for Acute coronary syndrome

Inclusion criteria

• {"criterion_text":"- Signed informed consent must be obtained prior to participation in the study."}
• {"criterion_text":"- Males and females, ≥18 years of age at the time of providing written informed consent."}
• {"criterion_text":"- Ability to understand the study's requirements and provide informed consent and comply with all required study procedures."}
• {"criterion_text":"- Hospitalization for an ACS event (STEMI or NSTEMI)."}
• {"criterion_text":"- Receiving treatment for the qualifying ACS event, according to clinical judgement, by means of medical treatment alone or percutaneous coronary revascularization."}
• {"criterion_text":"- Had a successful PCI (with or without stent) for the qualifying event, if PCI is required."}
• {"criterion_text":"- LDL-C value at the Screening visit measured by the local lab of: •\tLDL-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 •\tLDL-C ≥100 mg/dL in participant previously treated with low/moderate-intensity statin for at least 4 weeks before screening or •\tLDL-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)."}
• {"criterion_text":"- The participant must have a Baseline fasting LDL-C ≥70 mg/dL (local lab assessment) to be eligible for randomization."}
• {"criterion_text":"- Randomization within 7 days (≤ 7 days) following hospital admission for the qualifying ACS event and before/at discharge."}

Exclusion criteria

• {"criterion_text":"- 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: •\tHemodynamic instability: hypotension, defined as sustained systolic blood pressure of <90 mmHg due to cardiac failure with associated symptoms requiring inotropes •\tArrhythmic events: Ventricular storm (e.g., torsade, ventricular tachycardia, ventricular flutter) •\tCardiogenic shock or mechanical complication of myocardial infarction •\tNew York Heart Association (NYHA) class IV heart failure •\tLeft 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) •\tUncontrolled severe hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg prior to randomization despite antihypertensive therapy."}
• {"criterion_text":"- Ongoing or medical history of myopathy at the Screening visit."}
• {"criterion_text":"- 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 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)."}
• {"criterion_text":"- Participant who has undergone or is scheduled to undergo CABG for treatment of the qualifying ACS event."}
• {"criterion_text":"- Active liver disease defined as: (i) any known current infectious, neoplastic, or metabolic pathology of the liver or (ii) ALT elevation >3x ULN, or 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."}
• {"criterion_text":"- Renal insufficiency (eGFR <30 mL/min/1.73m2) at the Screening visit."}
• {"criterion_text":"- Fasting triglycerides value >400 mg/dL (4.52 mmol/L; assessed by local labs) at randomization visit."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Secondary hypercholesterolemia (based on medical history)."}
• {"criterion_text":"- Homozygous familial hypercholesterolemia (based on medical history)."}
• {"criterion_text":"- Participant on apheresis at Screening visit."}

Primary endpoints

• {"endpoint_text":"- Percent change in LDL-C from baseline to Day 150","definition_or_measurement_approach":"Measured as percent change in LDL-C from baseline to Day 150 (local laboratory assessments)."}

Secondary endpoints

• {"endpoint_text":"- •\tParticipants achieving LDL-C <70 mg/dL (yes, no) at Day 150 •\tParticipants achieving LDL-C <55 mg/dL (yes, no) at Day 150 •\tParticipants achieving LDL-C <100 mg/dL (yes, no) (among the subset of participants with LDL-C ≥100 mg/dL at baseline) at Day 150 •\tParticipants achieving ≥50% reduction from baseline in LDL-C (yes, no) at Day 150","definition_or_measurement_approach":""}
• {"endpoint_text":"- •\tPercent change from baseline to mean LDL-C over the double-blind treatment period (averaged over all post-baseline visits) •\tAbsolute change from baseline to mean LDL-C over the double-blind treatment period (averaged over all post-baseline visits) •\tPercent change in LDL-C from baseline to Day 30 and Day 90 •\tAbsolute change in LDL-C from baseline to Day 30, Day 90 and Day 150","definition_or_measurement_approach":""}
• {"endpoint_text":"- Percent change and absolute change in PCSK9 from baseline to Day 30, Day 90 and Day 150","definition_or_measurement_approach":""}
• {"endpoint_text":"- Percent change and absolute change from baseline in: apoB, VLDL, non-HDLC, HDL-C, total cholesterol and triglycerides at Day 150","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number and percentage of participants experiencing treatment emergent AEs or SAEs","definition_or_measurement_approach":""}

France

Earliest CTIS Part Ii Submission Date

26-11-2025

Latest Decision Or Authorization Date

16-02-2026

Processing Time Days

82

Number Of Sites

5

Number Of Participants

24

Germany

Earliest CTIS Part Ii Submission Date

21-01-2026

Latest Decision Or Authorization Date

19-02-2026

Processing Time Days

29

Number Of Sites

7

Number Of Participants

21

Hungary

Earliest CTIS Part Ii Submission Date

12-12-2025

Latest Decision Or Authorization Date

20-02-2026

Processing Time Days

70

Number Of Sites

11

Number Of Participants

30

Spain

Earliest CTIS Part Ii Submission Date

29-12-2025

Latest Decision Or Authorization Date

18-02-2026

Processing Time Days

51

Number Of Sites

9

Number Of Participants

34

Poland

Earliest CTIS Part Ii Submission Date

03-11-2025

Latest Decision Or Authorization Date

22-02-2026

Processing Time Days

111

Number Of Sites

4

Number Of Participants

26

Primary sponsor

Full Name

Novartis Pharma AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Syneos Health Inc.

Responsibilities

code 1

Name

IQVIA Limited

Responsibilities

Randomization of Participants, Management of drug supply, logistics, dispensing

Name

Icon Clinical Research Limited

Responsibilities

code 1

Name

Parexel International (IRL) Limited

Responsibilities

code 12

Third parties

• {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"Central Laboratory testing and reporting for China","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central Laboratory testing and reporting","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Randomization of Participants, Management of drug supply, logistics, dispensing","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"Medpace, Reference Laboratories","duties_or_roles":"Fasting PCSK9 testing","organisation_type":"Health care"}
• {"country":"United States","full_name":"Medpace Reference Laboratories LLC","duties_or_roles":"Fasting PCSK9 testing","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code 12","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}