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New shot may slash cholesterol right after a heart attack

NCT ID NCT07102628

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 6 times

Summary

This study tests whether starting inclisiran early during a hospital stay for a heart attack can lower bad cholesterol more than a placebo, when both are added to standard care. About 300 adults hospitalized for a heart attack will receive either inclisiran or a placebo shot at the start and again 90 days later. The main goal is to see if inclisiran leads to greater cholesterol reduction by day 150.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Inclisiran
What this could lead to
If it works, this could provide a new way to quickly lower bad cholesterol after a heart attack, potentially reducing the risk of future heart problems.
What could go wrong
This is still an early Phase 3 trial with 300 participants, so results may not apply to everyone. Inclisiran may not lower cholesterol enough or could have side effects not yet seen.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participant eligible for inclusion in this study must meet all the following criteria: At Screening: 1. Signed informed consent 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: 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 * 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. 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) 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. 4. Renal insufficiency (eGFR \<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).

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome hyperlipidemia Non-ST Elevated Myocardial Infarction ST-elevation myocardial infarction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute coronary syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Novartis Investigative Site

    WITHDRAWN

    Capital Federal, Buenos Aires, B1406, Argentina

  • Novartis Investigative Site

    RECRUITING

    Garran, Australian Capital Territory, 2605, Australia

  • Novartis Investigative Site

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Novartis Investigative Site

    RECRUITING

    Edmonton, Alberta, T6G 2B7, Canada

  • Novartis Investigative Site

    RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • Novartis Investigative Site

    WITHDRAWN

    London, Ontario, N6A 5W9, Canada

  • Novartis Investigative Site

    WITHDRAWN

    Newmarket, Ontario, J7Y 2P9, Canada

  • Novartis Investigative Site

    RECRUITING

    Montreal, Quebec, H1T 1C8, Canada

  • Novartis Investigative Site

    RECRUITING

    Québec, Quebec, G1V 4G5, Canada

  • Novartis Investigative Site

    RECRUITING

    Beijing, China, 100037, China

  • Novartis Investigative Site

    RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Novartis Investigative Site

    RECRUITING

    Luoyang, Henan, 471002, China

  • Novartis Investigative Site

    RECRUITING

    Xuzhou, Jiangsu, 221003, China

  • Novartis Investigative Site

    RECRUITING

    Nanchang, Jiangxi, 330009, China

  • Novartis Investigative Site

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100191, China

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100730, China

  • Novartis Investigative Site

    RECRUITING

    Fuzhou, 350001, China

  • Novartis Investigative Site

    RECRUITING

    Guangzhou, 510260, China

  • Novartis Investigative Site

    RECRUITING

    Guangzhou, 510280, China

  • Novartis Investigative Site

    RECRUITING

    Jining, 272011, China

  • Novartis Investigative Site

    RECRUITING

    Shanghai, 200032, China

  • Novartis Investigative Site

    RECRUITING

    Shanghai, 200120, China

  • Novartis Investigative Site

    RECRUITING

    Tianjin, 300052, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Chambray-lès-Tours, 37170, France

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Montpellier, 34295, France

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Nantes, 44093, France

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Pessac, 33604, France

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Poitiers, 86021, France

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Leipzig, Saxony, 04289, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Coburg, 96450, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Erfurt, 99089, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Essen, 45147, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Hennigsdorf, 16761, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Kiel, 24105, Germany

  • Novartis Investigative Site

    RECRUITING

    Hong Kong, Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    RECRUITING

    Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Pécs, Baranya, 7623, Hungary

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Budapest, 1083, Hungary

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Budapest, 1134, Hungary

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Miskolc, 3526, Hungary

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Belagavi, Karnataka, 590010, India

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Mumbai, Maharashtra, 400012, India

  • Novartis Investigative Site

    RECRUITING

    Nashik, Maharashtra, 422005, India

  • Novartis Investigative Site

    RECRUITING

    Bikaner, Rajasthan, 334003, India

  • Novartis Investigative Site

    COMPLETED

    Chikushino-shi, Fukuka, 8188516, Japan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Kitakyushu, Fukuoka, 8028555, Japan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Kamakura, Kanagawa, 2478533, Japan

  • Novartis Investigative Site

    WITHDRAWN

    Sagamihara, Kanagawa, 2520375, Japan

  • Novartis Investigative Site

    COMPLETED

    Bunkyo Ku, Tokyo, 1138431, Japan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Gdansk, 80-214, Poland

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Katowice, 40-635, Poland

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Krakow, 31-202, Poland

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Opole, 45-401, Poland

  • Novartis Investigative Site

    RECRUITING

    Seoul, Seoul, 06351, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 07804, South Korea

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Huelva, Andalusia, 21005, Spain

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    El Palmar, Murcia, 30120, Spain

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Las Palmas GC, 35010, Spain

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Madrid, 28034, Spain

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Madrid, 28046, Spain

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Salamanca, 37007, Spain

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Seville, 41013, Spain

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Valencia, 46010, Spain

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Bern, 3010, Switzerland

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Geneva, 1211, Switzerland

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Lucerne, 6000, Switzerland

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