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New shot may slash cholesterol after heart attacks

NCT ID NCT06501443

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding inclisiran (a twice-yearly injection) to standard care lowers LDL cholesterol more than standard care alone in 520 patients who recently had a heart attack, stroke, or urgent heart procedure. Participants are randomly assigned to receive inclisiran plus usual care or usual care alone. The main goal is to measure LDL cholesterol change after 330 days.

What this could mean

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

Active substance
Inclisiran (KJX839) injection
What this could lead to
If it works, this could provide a more effective way to lower cholesterol after a heart attack or stroke, reducing the risk of future events.
What could go wrong
This is a Phase 4 real-world study, so it may confirm known benefits but not produce a breakthrough. Results may vary by country and patient adherence.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 520 people

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

Started

Feb 2025

Expected to finish

Nov 2026

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 to 100 years

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: * Admitted for MI (Type 1 NSTEMI or STEMI), urgent (i.e., non-elective) coronary revascularization (PCI or CABG) or confirmed ischemic stroke. * Stable patient: Patient will be considered stable if they did not suffer cardiac arrest at presentation or if in the last 24 hours before randomization: * Was not in cardiogenic shock. * Did not required invasive hemodynamic, inotropic or vasopressor support. * Participants are required to be eligible for receiving inclisiran in accordance to approved local label. * Of note, patients who are initiated on statin therapy during the same hospitalization will not be excluded, as we expect a proportion of patients at baseline to not yet be on statin therapy in this real-world study. This will enhance the generalizability and pragmatic aspects of the study. However, because initiation of statin therapy at or near the time of enrollment could impact the primary outcome (if there is imbalance between the arms, or if there is differential stopping of statin therapy between the arms), we will stratify randomization by this factor and will pre-specify analyses in those who have vs. have not been initiated on statin therapy during the same hospitalization. Exclusion Criteria: * Currently on PCSK9i therapy (within last 3 months) * Current participation in another clinical study with another study drug * Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Baseline Visit * Pregnant or nursing (lactating) women * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception

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Conditions

The condition(s) this trial relates to.

acute myocardial infarction atherosclerosis atherosclerotic cardiovascular disease coronary artery disorder Hypercholesterolemia hypercholesterolemia, familial, 1 ischemic stroke

As listed by the trial registrant

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

Hypercholesterolaemia

How to take part

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

  1. The places running it

    10 sites in 2 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

    RECRUITING

    Corrientes, W3400CDS, Argentina

  • Novartis Investigative Site

    RECRUITING

    Salvador, Estado de Bahia, 40170-130, Brazil

  • Novartis Investigative Site

    RECRUITING

    Belo Horizonte, Minas Gerais, 30000, Brazil

  • Novartis Investigative Site

    RECRUITING

    Belo Horizonte, Minas Gerais, 30110-934, Brazil

  • Novartis Investigative Site

    RECRUITING

    Campo Largo, Paraná, 83606-177, Brazil

  • Novartis Investigative Site

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90560-032, Brazil

  • Novartis Investigative Site

    WITHDRAWN

    Blumenau, Santa Catarina, 89010-500, Brazil

  • Novartis Investigative Site

    RECRUITING

    São José, Santa Catarina, 88103-901, Brazil

  • Novartis Investigative Site

    RECRUITING

    São José, São Paulo, 15015-110, Brazil

  • Novartis Investigative Site

    RECRUITING

    Campina Gde Do Sul, 83430 000, Brazil

  • Novartis Investigative Site

    RECRUITING

    Salvador, 40323-010, Brazil

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