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Acute Coronary SyndromePhase 3ACSNCT07102628

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

A Phase 3 study testing Inclisiran in people with Acute Coronary Syndrome, run by Novartis Pharmaceuticals at 69 sites in 14 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Inclisiran
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
69 sitesin 14 countries
Study dates
3 Oct 2025to 11 Feb 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant eligible for inclusion in this study must meet all the following criteria:
  • 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).
Show all 15Show fewer
  • 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 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:
  • 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.

Who cannot join

  • 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.
  • 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
Show all 19Show fewer
  • 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 or for whom an apheresis is planned during study (from Day 1 to EOS).
  • 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).

Trial locations and contacts

69 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

+41613241111

novartis.email@novartis.com

Novartis Pharmaceuticals contact

+81337978748

69 sites in 14 countries

China15 sites, 15 recruiting

  • Novartis Investigative Site

    Beijing, China, 100037

    Recruiting

  • Novartis Investigative Site

    Beijing, 100191

    Recruiting

  • Novartis Investigative Site

    Beijing, 100730

    Recruiting

  • Novartis Investigative Site

    Fuzhou, 350001

    Recruiting

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080

    Recruiting

  • Novartis Investigative Site

    Guangzhou, 510260

    Recruiting

  • Novartis Investigative Site

    Guangzhou, 510280

    Recruiting

  • Novartis Investigative Site

    Jining, 272011

    Recruiting

  • Novartis Investigative Site

    Luoyang, Henan, 471002

    Recruiting

  • Novartis Investigative Site

    Nanchang, Jiangxi, 330009

    Recruiting

  • Novartis Investigative Site

    Shanghai, 200032

    Recruiting

  • Novartis Investigative Site

    Shanghai, 200120

    Recruiting

  • Novartis Investigative Site

    Tianjin, 300052

    Recruiting

  • Novartis Investigative Site

    Wenzhou, Zhejiang, 325000

    Recruiting

  • Novartis Investigative Site

    Xuzhou, Jiangsu, 221003

    Recruiting

Other trials in China

Spain9 sites

  • Novartis Investigative Site

    El Palmar, Murcia, 30120

    Active, not recruiting

  • Novartis Investigative Site

    Huelva, Andalusia, 21005

    Active, not recruiting

  • Novartis Investigative Site

    Las Palmas GC, 35010

    Active, not recruiting

  • Novartis Investigative Site

    Madrid, 28034

    Active, not recruiting

  • Novartis Investigative Site

    Madrid, 28046

    Active, not recruiting

  • Novartis Investigative Site

    Salamanca, 37007

    Active, not recruiting

  • Novartis Investigative Site

    Santiago Compostela, A Coruna, 15706

    Active, not recruiting

  • Novartis Investigative Site

    Seville, 41013

    Active, not recruiting

  • Novartis Investigative Site

    Valencia, 46010

    Active, not recruiting

Other trials in Spain

Canada6 sites, 4 recruiting

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 2B7

    Recruiting

  • Novartis Investigative Site

    Hamilton, Ontario, L8L 2X2

    Recruiting

  • Novartis Investigative Site

    London, Ontario, N6A 5W9

    Withdrawn

  • Novartis Investigative Site

    Montreal, Quebec, H1T 1C8

    Recruiting

  • Novartis Investigative Site

    Newmarket, Ontario, J7Y 2P9

    Withdrawn

  • Novartis Investigative Site

    Québec, Quebec, G1V 4G5

    Recruiting

Other trials in Canada

Germany6 sites

  • Novartis Investigative Site

    Coburg, 96450

    Active, not recruiting

  • Novartis Investigative Site

    Erfurt, 99089

    Active, not recruiting

  • Novartis Investigative Site

    Essen, 45147

    Active, not recruiting

  • Novartis Investigative Site

    Hennigsdorf, 16761

    Active, not recruiting

  • Novartis Investigative Site

    Kiel, 24105

    Active, not recruiting

  • Novartis Investigative Site

    Leipzig, Saxony, 04289

    Active, not recruiting

Other trials in Germany

France5 sites

  • Novartis Investigative Site

    Chambray-lès-Tours, 37170

    Active, not recruiting

  • Novartis Investigative Site

    Montpellier, 34295

    Active, not recruiting

  • Novartis Investigative Site

    Nantes, 44093

    Active, not recruiting

  • Novartis Investigative Site

    Pessac, 33604

    Active, not recruiting

  • Novartis Investigative Site

    Poitiers, 86021

    Active, not recruiting

Other trials in France

Hungary5 sites

  • Novartis Investigative Site

    Budapest, 1083

    Active, not recruiting

  • Novartis Investigative Site

    Budapest, 1134

    Active, not recruiting

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032

    Active, not recruiting

  • Novartis Investigative Site

    Miskolc, 3526

    Active, not recruiting

  • Novartis Investigative Site

    Pécs, Baranya, 7623

    Active, not recruiting

Other trials in Hungary

Japan5 sites

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 1138431

    Completed

  • Novartis Investigative Site

    Chikushino-shi, Fukuka, 8188516

    Completed

  • Novartis Investigative Site

    Kamakura, Kanagawa, 2478533

    Active, not recruiting

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 8028555

    Active, not recruiting

  • Novartis Investigative Site

    Sagamihara, Kanagawa, 2520375

    Withdrawn

Other trials in Japan

India4 sites, 2 recruiting

  • Novartis Investigative Site

    Belagavi, Karnataka, 590010

    Active, not recruiting

  • Novartis Investigative Site

    Bikaner, Rajasthan, 334003

    Recruiting

  • Novartis Investigative Site

    Mumbai, Maharashtra, 400012

    Active, not recruiting

  • Novartis Investigative Site

    Nashik, Maharashtra, 422005

    Recruiting

Other trials in India

Poland4 sites

  • Novartis Investigative Site

    Gdansk, 80-214

    Active, not recruiting

  • Novartis Investigative Site

    Katowice, 40-635

    Active, not recruiting

  • Novartis Investigative Site

    Krakow, 31-202

    Active, not recruiting

  • Novartis Investigative Site

    Opole, 45-401

    Active, not recruiting

Other trials in Poland

Switzerland3 sites

  • Novartis Investigative Site

    Bern, 3010

    Active, not recruiting

  • Novartis Investigative Site

    Geneva, 1211

    Active, not recruiting

  • Novartis Investigative Site

    Lucerne, 6000

    Active, not recruiting

Other trials in Switzerland

Australia2 sites, 2 recruiting

  • Novartis Investigative Site

    Clayton, Victoria, 3168

    Recruiting

  • Novartis Investigative Site

    Garran, Australian Capital Territory, 2605

    Recruiting

Other trials in Australia

Hong Kong2 sites, 2 recruiting

  • Novartis Investigative Site

    Hong Kong, Hong Kong, 999077

    Recruiting

  • Novartis Investigative Site

    Hong Kong, 999077

    Recruiting

Other trials in Hong Kong

South Korea2 sites, 2 recruiting

  • Novartis Investigative Site

    Seoul, Seoul, 06351

    Recruiting

  • Novartis Investigative Site

    Seoul, 07804

    Recruiting

Other trials in South Korea

Argentina1 site

  • Novartis Investigative Site

    Capital Federal, Buenos Aires, B1406

    Withdrawn

Other trials in Argentina

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes: Victorion - RIDES

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.

Being tested
Placebo, Inclisiran
Keywords
KJX839, Acute Coronary Syndrome, ACS, NSTEMI, STEMI, Inclisiran, LDL-C, Hyperlipidemia
Medical subject headings
Acute Coronary Syndrome, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

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

  • InclisiranDrug

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

Study groups in NCT07102628
Study groupRoleWhat they receive
Inclisiran sodium 300 mg s.c. + Standard treatmentExperimental* 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
Receives: Drug: Inclisiran
Matching placebo + Standard treatmentPlacebo 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
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From baseline to Day 150

Secondary outcomes (10)

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: At Day 150

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2025
  2. Study start3 Oct 2025
  3. Primary completion11 Feb 2027 (estimated)
  4. Study completion11 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07102628
Sponsor's protocol ID
CKJX839A12309
Other IDs
2025-521670-34, 2025
Acronym
ACS
Status last verified
Sep 2026
First submitted
31 Jul 2025
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inclisiran in people with Acute Coronary Syndrome, run by Novartis Pharmaceuticals at 69 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in China, Spain, Canada, Germany, France and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change in LDL-C (time frame: From baseline to Day 150). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07102628.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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