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New cholesterol drug tested right after heart attack to stop second one

NCT ID NCT07142265

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Updated 2 times

Summary

This study tests whether starting inclisiran early after a heart attack can lower bad cholesterol and reduce the risk of another heart attack or stroke. About 300 adults in Russia who had a recent heart attack and have high cholesterol will receive inclisiran injections. Researchers will track heart events, cholesterol levels, and safety over one year.

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.

Participants

About 300 people

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

Started

Sep 2025

Expected to finish

Sep 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.

Who is studied

The study will include patients with inclisiran initiation in 14 ± 5 days after STEMI/non-STEMI. Index event is a first diagnosed STEMI/non-STEMI.

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: * Adult patients of both genders * Myocardial Infarction diagnosis * Dyslipidemia diagnosis * The first injection of inclisiran no later than 14 ± 5 days after the STEMI/non-STEMI * LDL-C \> 5 mmol/L (statin-naive patients) or LDL-C \> 2.5 mmol/L (on the basis of statin MTD) at the time of hospitalization or no target LDL-C level (\> 1.4 mmol/L or no LDL-C level decrease by 50% on statin MTD + ezetimibe) * Signed Informed Consent Form (ICF) Exclusion Criteria: * Severe oncological and somatic diseases with system and organ failure\* * Competing diseases that caused emergency hospitalization (pulmonary thromboembolism, aortic dissection) * History of therapy with PCSK9 inhibitors * Active inflammatory liver disease or the levels of AST, ALT \> 3 times, or total bilirubin \> 2 times higher than the upper limit of norm * Any other MACE in the anamnesis

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Conditions

The condition(s) this trial relates to.

myocardial infarction

As listed by the trial registrant

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

Myocardial infarction

How to take part

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

  1. The places running it

    18 sites. 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

    Cheboksary, 428000, Russia

  • Novartis Investigative Site

    RECRUITING

    Grozny, 364051, Russia

  • Novartis Investigative Site

    RECRUITING

    Kaluga, 248000, Russia

  • Novartis Investigative Site

    RECRUITING

    Kemerovo, 650002, Russia

  • Novartis Investigative Site

    RECRUITING

    Khanty-Mansiysk, 628012, Russia

  • Novartis Investigative Site

    RECRUITING

    Moscow, 105203, Russia

  • Novartis Investigative Site

    RECRUITING

    Moscow, 119607, Russia

  • Novartis Investigative Site

    RECRUITING

    Moscow, 121552, Russia

  • Novartis Investigative Site

    RECRUITING

    Novosibirsk, 630051, Russia

  • Novartis Investigative Site

    RECRUITING

    Orenburg, 460018, Russia

  • Novartis Investigative Site

    RECRUITING

    Penza, 440026, Russia

  • Novartis Investigative Site

    RECRUITING

    Petrozavodsk, 185019, Russia

  • Novartis Investigative Site

    RECRUITING

    Rostov-on-Don, 344010, Russia

  • Novartis Investigative Site

    RECRUITING

    S Petersburg, 192242, Russia

  • Novartis Investigative Site

    RECRUITING

    Samara, 443070, Russia

  • Novartis Investigative Site

    RECRUITING

    Syktyvkar, 167981, Russia

  • Novartis Investigative Site

    RECRUITING

    Tomsk, 634009, Russia

  • Novartis Investigative Site

    RECRUITING

    Ulan-Ude, 670031, Russia

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