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RecruitingNCT07102628ACSUpdated Sep 16, 2026

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

A Phase 3 interventional study of Placebo and Inclisiran in Acute Coronary Syndrome, sponsored by Novartis Pharmaceuticals. Recruiting at 69 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year 1 month later.
Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This is a multicenter, prospective, randomized, double-blind, placebo-controlled, two arms, parallel groups clinical trial in participants experiencing an ACS (STEMI or NSTEMI) of recent onset. The study drug treatment (inclisiran/placebo) will be initiated at randomization (Day 1) and before discharge.

The study consists of:

  1. Screening visit within 7 days (≤ 7 days) from hospital admission. Screening visit might happen at hospital admission day or any time after hospital admission and before randomization (Day 1).

  2. Randomization/Baseline visit (Day 1) within 7 days (≤ 7 days) from hospital admission and before or at day of discharge.

    The discharge can happen any time after randomization and first study drug administration (Day 1).

  3. Double-blinded treatment period (150 days).
  4. Scheduled safety calls in between visits during the double-blind treatment period (they do not replace on-site visits)
  5. Safety Follow-up call (30 days after EOS visit)

Screening and randomization visits must happen during the in-hospital phase, within 7 days (≤ 7 days), and before discharge. The Screening period, of no more than 6 days after the date of hospital admission, will be used to determine if patients qualify to enter the double-blind treatment phase of the study. Screening and Randomization/Day 1 visits cannot occur on the same day. The overall study duration is 150 days.

02

Conditions studied

  • Acute Coronary Syndrome

Keywords

  • KJX839
  • Acute Coronary Syndrome
  • ACS
  • NSTEMI
  • STEMI
  • Inclisiran
  • LDL-C
  • Hyperlipidemia
03

In context

Acute Coronary Syndrome

1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.

This study's planned enrollment of 300 is above the median of 200 across 865 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.

Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.

Browse Novartis Pharmaceuticals studies →All Novartis studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Participant eligible for inclusion in this study must meet all the following criteria:

At Screening:

  1. Signed must be obtained prior to participation in the study.
  2. Males and females, ≥18 years of age at the time of providing written informed consent.
  3. Ability to understand study's requirements and provide informed consent and comply with all required study procedures.
  4. Hospitalization for a ACS event (STEMI or NSTEMI).
  5. Receiving treatment for the qualifying ACS event, according to clinical judgement, by means of medical treatment alone or percutaneous coronary revascularization.
  6. Had a successful PCI (with or without stent) for the qualifying event if a PCI was required.

  7. LDL-C values measured by the local lab either at the Screening visit or results from local lab tests performed prior to ICF signature, strictly as part of the routine clinical practice in this emergency ACS setting and not older than 2 days 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 ≥80 mg/dL in participant previously treated with low/moderate-intensity statin for at least 4 weeks before screening or
    • LDL-C ≥100 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:

  8. The participant must have a Baseline fasting LDL-C ≥70 mg/dL (local lab assessment) to be eligible for randomization.
  9. Randomization within 7 days (≤ 7 days) following hospital admission for the qualifying ACS event and before/at discharge.

Exclusion criteria

Exclusion Criteria:

Participant meeting any of the following criteria is not eligible for inclusion in this study.

Only for Japan: For exclusion criteria 6, investigator judgment should be documented in the source data document.

  1. 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
    • Sustained arrhythmic events such as: ventricular storm (e.g., torsade, ventricular tachycardia, ventricular flutter) not resolved before randomization
    • Cardiogenic shock or mechanical complication of myocardial infarction
    • (NYHA) class IV heart failure
    • \<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.
  2. Participant who has undergone or is scheduled to undergo CABG for treatment of the qualifying ACS event.
  3. Active liver disease defined as: (i) any known current infectious, neoplastic, or metabolic pathology of the liver or (ii) (ALT) elevation >3x or aspartate aminotransferase (AST) elevation >3x ULN, or total 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.
  4. Renal insufficiency ( \<30 mL/min/1.73m2) at the Screening visit.
  5. Fasting triglycerides value >400 mg/dL (4.52 mmol/L; assessed by local labs) at randomization visit.
  6. 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.
  7. Secondary hypercholesterolemia (based on medical history).
  8. Homozygous familial hypercholesterolemia (based on medical history).
  9. Participant on apheresis at the Screening visit or for whom an apheresis is planned during study (from Day 1 to EOS).
  10. Ongoing or medical history of myopathy at the Screening visit.
  11. 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).
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Inclisiran sodium 300 mg s.c. + Standard treatment

    * 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

  • Placebo comparator
    Matching placebo + Standard treatment

    * 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

  • DrugPlacebo

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

  • DrugInclisiran

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

06

What researchers measure

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

    Time frame: From baseline to Day 150

Secondary outcomes

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

    To assess the proportion of participants reaching pre-specified LDL-C target (\<70 mg/dL) on inclisiran treatment compared to placebo, on top of SoC

    Time frame: At Day 90 and Day 150

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

    To assess the proportion of participants reaching pre-specified LDL-C target (\<55 mg/dL) on inclisiran treatment compared to placebo, on top of SoC

    Time frame: At Day 90 and Day 150

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

    To assess the proportion of participants reaching pre-specified LDL-C target (\<100 mg/dL) on inclisiran treatment compared to placebo, on top of SoC

    Time frame: At Day 90 and Day 150

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

    To assess the proportion of participants reaching pre-specified LDL-C target (≥50% reduction from baseline) on inclisiran treatment compared to placebo, on top of SoC

    Time frame: At Day 90 and Day 150

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

    To assess the mean change (averaged over all post-baseline visits), and the change by visit, from baseline in LDL-C for participants receiving inclisiran treatment compared to placebo, on top of SoC

    Time frame: From baseline to Day 30, Day 90 and Day 150

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

    To assess the mean change (averaged over all post-baseline visits), and the change by visit, from baseline in LDL-C for participants receiving inclisiran treatment compared to placebo, on top of SoC

    Time frame: From baseline to Day 30, Day 90 and Day 150

  7. Percent change in LDL-C

    To assess the mean change (averaged over all post-baseline visits), and the change by visit, from baseline in LDL-C for participants receiving inclisiran treatment compared to placebo, on top of SoC

    Time frame: From baseline to Day 30 and Day 90

  8. Absolute change in LDL-C

    To assess the mean change (averaged over all post-baseline visits), and the change by visit, from baseline in LDL-C for participants receiving inclisiran treatment compared to placebo, on top of SoC

    Time frame: From baseline to Day 30, Day 90 and Day 150

  9. Percent change and absolute change in PCSK9

    To assess the change of PCSK9 from baseline to Day 150 in participants on inclisiran treatment compared to placebo, on top of SoC

    Time frame: From baseline to Day 30, Day 90 and Day 150

  10. Percent change and absolute change from baseline in: apoB, VLDL, non-HDLC, HDL-C, total cholesterol and triglycerides

    To assess the change in plasma lipoproteins and triglycerides from baseline to Day 150 in participants on inclisiran treatment compared to placebo, on top of SoC

    Time frame: At Day 150

07

Study locations

27 of 69 sites recruiting
  • Novartis Investigative Site
    Capital Federal, Buenos Aires B1406, Argentina
    Withdrawn

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Garran, Australian Capital Territory 2605, Australia
    Recruiting
  • Novartis Investigative Site
    Clayton, Victoria 3168, Australia
    Recruiting
  • Novartis Investigative Site
    Edmonton, Alberta T6G 2B7, Canada
    Recruiting
  • Novartis Investigative Site
    Hamilton, Ontario L8L 2X2, Canada
    Recruiting
  • Novartis Investigative Site
    London, Ontario N6A 5W9, Canada
    Withdrawn

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Newmarket, Ontario J7Y 2P9, Canada
    Withdrawn

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Montreal, Quebec H1T 1C8, Canada
    Recruiting
  • Novartis Investigative Site
    Québec, Quebec G1V 4G5, 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
    Fuzhou, 350001, 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
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Montpellier, 34295, France
    Active, not recruiting

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  • Novartis Investigative Site
    Nantes, 44093, France
    Active, not recruiting

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  • Novartis Investigative Site
    Pessac, 33604, France
    Active, not recruiting

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  • Novartis Investigative Site
    Poitiers, 86021, France
    Active, not recruiting

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  • Novartis Investigative Site
    Leipzig, Saxony 04289, Germany
    Active, not recruiting

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  • Novartis Investigative Site
    Coburg, 96450, Germany
    Active, not recruiting

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  • Novartis Investigative Site
    Erfurt, 99089, Germany
    Active, not recruiting

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  • Novartis Investigative Site
    Essen, 45147, Germany
    Active, not recruiting

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  • Novartis Investigative Site
    Hennigsdorf, 16761, Germany
    Active, not recruiting

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  • Novartis Investigative Site
    Kiel, 24105, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • 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
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Debrecen, Hajdu Bihar Megye 4032, Hungary
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Budapest, 1083, Hungary
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Budapest, 1134, Hungary
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Miskolc, 3526, Hungary
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Belagavi, Karnataka 590010, India
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Mumbai, Maharashtra 400012, India
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Nashik, Maharashtra 422005, India
    Recruiting
  • Novartis Investigative Site
    Bikaner, Rajasthan 334003, India
    Recruiting
  • Novartis Investigative Site
    Chikushino-shi, Fukuka 8188516, Japan
    Completed

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Kitakyushu, Fukuoka 8028555, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Kamakura, Kanagawa 2478533, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Sagamihara, Kanagawa 2520375, Japan
    Withdrawn

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Bunkyo Ku, Tokyo 1138431, Japan
    Completed

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Gdansk, 80-214, Poland
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Katowice, 40-635, Poland
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Krakow, 31-202, Poland
    Active, not recruiting

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  • Novartis Investigative Site
    Opole, 45-401, Poland
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • 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
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Huelva, Andalusia 21005, Spain
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    El Palmar, Murcia 30120, Spain
    Active, not recruiting

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  • Novartis Investigative Site
    Las Palmas GC, 35010, Spain
    Active, not recruiting

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  • Novartis Investigative Site
    Madrid, 28034, Spain
    Active, not recruiting

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  • Novartis Investigative Site
    Madrid, 28046, Spain
    Active, not recruiting

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  • Novartis Investigative Site
    Salamanca, 37007, Spain
    Active, not recruiting

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  • Novartis Investigative Site
    Seville, 41013, Spain
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Valencia, 46010, Spain
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Bern, 3010, Switzerland
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Geneva, 1211, Switzerland
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Novartis Investigative Site
    Lucerne, 6000, Switzerland
    Active, not recruiting

    Not enrolling at this site — choose another above.

08

References and documents

Individual participant data

Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Feb 2027, 16 months after the start.

Of 39 phase 3 interventional studies under Acute Coronary Syndrome, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 52. This study's planned 16 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 31, 2025
First posted
Aug 4, 2025
StartActual
Oct 3, 2025
Primary completionEst.
Feb 11, 2027
CompletionEst.
Feb 11, 2027
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07102628
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Aug 4, 2025
Start date
Oct 3, 2025
Primary completion
Feb 11, 2027 (estimated)
Completion
Feb 11, 2027 (estimated)
Last update
Sep 16, 2026

Study contacts

Novartis Pharmaceuticals
Contact
novartis.email@novartis.com
+41613241111
Novartis Pharmaceuticals
Contact
+81337978748
Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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