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Evaluation of efficacy and safety of early in hospital initiation of inclisiran treatment in patients with acute coronary syndromes
EU CTIS ID: 2025-521670-34-00
What this study is testing
To demonstrate the superiority of inclisiran treatment compared to placebo, when initiated before/at discharge, in combination with SoC (statin therapy +/- LLT or non-statin treatment in case of documented statin intolerance) on LDL-C reduction at Day 150
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 the study's requirements and provide informed consent and comply with all required study procedures.
- Hospitalization for an 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 PCI is required.
You likely can't join if
- 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 <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.
- 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 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).
- 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) 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.
- Renal insufficiency (eGFR <30 mL/min/1.73m2) at the Screening visit.
See the full eligibility criteria
Who can join
- 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 the study's requirements and provide informed consent and comply with all required study procedures.
- Hospitalization for an 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 PCI is 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.
What rules you out
- 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 <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.
- 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 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).
- 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) 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.
- 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 Screening visit.
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- Japan
- India
- China
- Korea, Republic of
- Hong Kong
- Australia
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; Japan; India; China; Korea, Republic of; Hong Kong and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.