Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes

NCT07102628 | Recruiting Phase 3

• 2 other identifiers: CKJX839A123092025-521670-34
• Study Type: interventional
• Target: 300
• Locations: 13 countries
• Sites: 58

Brief Summary

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.

Conditions

Acute Coronary Syndrome

Keywords

KJX839; Acute Coronary Syndrome; ACS; NSTEMI; STEMI; Inclisiran; LDL-C; Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Percent change in LDL-C

  To demonstrate the superiority of inclisiran treatment compared to placebo, when initiated before/at discharge, in combination with standard of care (SoC) (statin therapy +/- LLT (Lipid Lowering Therapy) or non-statin treatment in case of documented statin intolerance) on LDL-C reduction at Day 150

  From baseline to Day 150

Secondary Outcomes (10)

• Participants achieving LDL-C <70 mg/dL (yes, no)

  At Day 150

• Participants achieving LDL-C <55 mg/dL (yes, no)

  At Day 150

• Participants achieving LDL-C <100 mg/dL (yes, no) (among the subset of participants with LDL-C ≥100 mg/dL at baseline)

  At Day 150

• Participants achieving ≥50% reduction from baseline in LDL-C (yes, no)

  At Day 150

• Percent change from baseline to mean LDL-C over the double-blind treatment period (averaged over all post-baseline visits)

  From baseline to Day 30, Day 90 and Day 150

Study Arms (2)

Inclisiran sodium 300 mg s.c. + Standard treatment

EXPERIMENTAL

* Inclisiran sodium 300 mg subcutaneous (s.c.) on top of HIS (+/- LLT) or non-statin LLT in statin intolerant participants * KJX839 284 mg / 1.5 mL (Dose: 300 mg) * Pharmaceutical Dosage Form: solution for subcutaneous injection

Drug: Inclisiran

Matching placebo + Standard treatment

PLACEBO COMPARATOR

* Matching placebo on top of HIS (+/- LLT) or non-statin LLT in statin intolerant participants * KJX839 Placebo / 1.5 mL (Dose: 0 mg) * Pharmaceutical Dosage Form: solution for subcutaneous injection

Drug: Placebo

Interventions

Placebo DRUG

The participants will receive placebo subcutaneous at randomization (Day 1, Baseline visit) and Day 90

Matching placebo + Standard treatment

Inclisiran DRUG

The participants will receive Inclisiran sodium 300 mg subcutaneous at randomization (Day 1, Baseline visit) and Day 90

Inclisiran sodium 300 mg s.c. + Standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At Screening:
• 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).
• At Randomization:
• 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.

You may not qualify 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.
• 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 \<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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (58)

Novartis Investigative Site

Clayton, Victoria, 3168, Australia

RECRUITING

Novartis Investigative Site

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Novartis Investigative Site

Beijing, China, 100037, China

RECRUITING

Novartis Investigative Site

Guangzhou, Guangdong, 510080, China

RECRUITING

Novartis Investigative Site

Luoyang, Henan, 471002, China

RECRUITING

Novartis Investigative Site

Xuzhou, Jiangsu, 221003, China

RECRUITING

Novartis Investigative Site

Nanchang, Jiangxi, 330009, China

RECRUITING

Novartis Investigative Site

Wenzhou, Zhejiang, 325000, China

RECRUITING

Novartis Investigative Site

Beijing, 100191, China

RECRUITING

Novartis Investigative Site

Beijing, 100730, China

RECRUITING

Novartis Investigative Site

Guangzhou, 510260, China

RECRUITING

Novartis Investigative Site

Guangzhou, 510280, China

RECRUITING

Novartis Investigative Site

Jining, 272011, China

RECRUITING

Novartis Investigative Site

Shanghai, 200032, China

RECRUITING

Novartis Investigative Site

Shanghai, 200120, China

RECRUITING

Novartis Investigative Site

Tianjin, 300052, China

RECRUITING

Novartis Investigative Site

Chambray-lès-Tours, 37170, France

RECRUITING

Novartis Investigative Site

Montpellier, 34295, France

RECRUITING

Novartis Investigative Site

Nantes, 44093, France

RECRUITING

Novartis Investigative Site

Pessac, 33604, France

RECRUITING

Novartis Investigative Site

Poitiers, 86021, France

RECRUITING

Novartis Investigative Site

Leipzig, Saxony, 04289, Germany

RECRUITING

Novartis Investigative Site

Coburg, 96450, Germany

RECRUITING

Novartis Investigative Site

Essen, 45147, Germany

RECRUITING

Novartis Investigative Site

Hennigsdorf, 16761, Germany

RECRUITING

Novartis Investigative Site

Kiel, 24105, Germany

RECRUITING

Novartis Investigative Site

Hong Kong, Hong Kong, 999077, Hong Kong

RECRUITING

Novartis Investigative Site

Hong Kong, 999077, Hong Kong

RECRUITING

Novartis Investigative Site

Pécs, Baranya, 7623, Hungary

RECRUITING

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, 4032, Hungary

RECRUITING

Novartis Investigative Site

Budapest, 1134, Hungary

RECRUITING

Novartis Investigative Site

Budapest, H-1083, Hungary

RECRUITING

Novartis Investigative Site

Miskolc, 3526, Hungary

RECRUITING

Novartis Investigative Site

Belagavi, Karnataka, 590010, India

RECRUITING

Novartis Investigative Site

Nashik, Maharashtra, 422005, India

RECRUITING

Novartis Investigative Site

Bikaner, Rajasthan, 334003, India

RECRUITING

Novartis Investigative Site

Chikushino-shi, Fukuka, 818-8516, Japan

RECRUITING

Novartis Investigative Site

Kitakyushu, Fukuoka, 8028555, Japan

RECRUITING

Novartis Investigative Site

Kamakura, Kanagawa, 247-8533, Japan

RECRUITING

Novartis Investigative Site

Sagamihara, Kanagawa, 252-0375, Japan

RECRUITING

Novartis Investigative Site

Bunkyo Ku, Tokyo, 1138431, Japan

RECRUITING

Novartis Investigative Site

Gdansk, 80-214, Poland

RECRUITING

Novartis Investigative Site

Krakow, 31 202, Poland

RECRUITING

Novartis Investigative Site

Opole, 45-401, Poland

RECRUITING

Novartis Investigative Site

Seoul, Seoul, 06351, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 07804, South Korea

RECRUITING

Novartis Investigative Site

Santiago Compostela, A Coruna, 15706, Spain

RECRUITING

Novartis Investigative Site

Huelva, Andalusia, 21005, Spain

RECRUITING

Novartis Investigative Site

El Palmar, Murcia, 30120, Spain

RECRUITING

Novartis Investigative Site

Las Palmas GC, 35010, Spain

RECRUITING

Novartis Investigative Site

Madrid, 28034, Spain

RECRUITING

Novartis Investigative Site

Madrid, 28046, Spain

RECRUITING

Novartis Investigative Site

Salamanca, 37007, Spain

RECRUITING

Novartis Investigative Site

Seville, 41013, Spain

RECRUITING

Novartis Investigative Site

Valencia, 46010, Spain

RECRUITING

Novartis Investigative Site

Bern, 3010, Switzerland

RECRUITING

Novartis Investigative Site

Geneva, 1211, Switzerland

RECRUITING

Novartis Investigative Site

Lucerne, 6000, Switzerland

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Non-ST Elevated Myocardial Infarction; ST Elevation Myocardial Infarction; Hyperlipidemias

Interventions

ALN-PCS

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+81337978748

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 4, 2025
• Study Start: October 3, 2025
• Primary Completion (Estimated): February 11, 2027
• Study Completion (Estimated): February 11, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

JP (5); CN (14); HK (2); IN (3); KR (2); ES (9); CA (1); FR (5); DE (5); AU (1); PL (3); HU (5); CH (3)