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New triple drug combo aims to slash cholesterol after heart attacks

NCT ID NCT07440381

Disease control Sponsor: Heart Care Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether giving a triple combination of cholesterol-lowering drugs (a high-intensity statin, ezetimibe, and bempedoic acid) right after a heart attack works better than usual care. About 600 adults hospitalized for a heart attack will be randomly assigned to the triple therapy or standard treatment. The main goal is to see if the triple therapy lowers LDL cholesterol more at 8 weeks.

What this could mean

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

Active substance
bempedoic acid (a cholesterol-lowering drug) combined with a high-intensity statin and ezetimibe
What this could lead to
If it works, this could show that starting a triple cholesterol-lowering pill early after a heart attack is better than usual care at quickly reducing bad cholesterol.
What could go wrong
This is a phase 3 trial, but it has not started recruiting yet. The benefit may be modest, and bempedoic acid can cause side effects like muscle pain or gout. Results may not apply to all patients.

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 600 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Age ≥18 years * Male and females at birth * Admitted for ACS caused by an atherothrombotic coronary event; * Calculated LDL-c: 70-140 mg/dL within 24 hours from admission for the ACS index event * Lipid lowering therapy on admission consisting of a low/moderate intensity statin or a high intensity statin (HIS); or no lipid lowering therapy (naïve patients) * Lipid-lowering therapy at discharge (at the time of randomization) consisting of HIS or HIS + ezetimibe * Scheduled home discharge * Written informed consent provided; patients who are unable to give informed consent for any reason will be excluded from the study. Exclusion Criteria: * Patients already treated with HIS+Ezetimibe on admission for the ACS event, * Patients currently, previously or planned to be treated with PCSK9i or inclisiran, * Patients treated currently or in the last 3 months with bempedoic acid or in whom this treatment is planned in the following 8 weeks, * Known allergy, sensitivity or intolerance to bempedoic acid and/or study drugs' formulation ingredients (e.g. lactose intolerance), * Patients with history of documented intolerance to statins, ezetimibe or bempedoic acid * Patients with known Familial Hypercholesterolemia (FH; heterozygous or homozygous), * Patients with plasma triglycerides concentration exceeding 400 mg/dL (4.52 mmol/L), * Patients with dysbetalipoproteinemia (type III hyperlipoproteinemia), * Unstable clinical status (hemodynamic or electrical instability), * Severe renal dysfunction (eGFR \<30 ml/min/1.73m2 using the CKD-EPI formula), * Active liver disease or hepatic dysfunction (AST or ALT levels \> 3xUNL), * Current enrolment in another investigational device or drug study, * Current pregnancy, lactation or women of childbearing potential, unless using highly effective contraception, * Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome hyperlipidemia

As listed by the trial registrant

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

Acute coronary syndromes LIPIDS Secondary prevention

How to take part

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

  1. The places running it

    35 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

  • Aor San Carlo - Ospedale San Carlo - Ssd Terapia Intensiva Cardiologica

    Potenza, Italy

  • Aorn San Giuseppe Moscati - U.O. Cardiologia/Utic 'D. Rotiroti'

    Avellino, Italy

  • Aou Careggi - Interventistica Cardiologica Strutturale

    Florence, Italy

  • Aou Policlinico P. Giaccone - U.O.C. Cardiologia

    Palermo, Italy

  • Arcispedale Sant'Anna - U.O. Cardiologia

    Ferrara, Italy

  • Arnas P.O. Civico E Benfratelli - Uoc Utic

    Palermo, Italy

  • Asst Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica

    Milan, Italy

  • Azienda Ospedaliera Cannizzaro - Uoc Cardiologia

    Catania, Italy

  • Azienda Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia D'Emergenza Con Utic

    Caserta, Italy

  • FONDAZIONE IRCCS POLICLINICO SAN MATTEO - UOC Cardiologia

    Pavia, Italy

  • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico - Uoc Malattie Cardiovascolari

    Milan, Italy

  • Irccs Ospedale Galeazzi - Sant'Ambrogio - Cardiologia Universitaria Ed Imaging Cardiaco

    Milan, Italy

  • Nuovo Ospedale Di Vimercate - S.C. Cardiologia E Utic

    Vimercate, Italy

  • OSPEDALE CA' FONCELLO - UOC Cardiologia

    Treviso, Italy

  • OSPEDALE CIVILE FORNAROLI - UO Cardiologia

    Magenta, Italy

  • OSPEDALE DEGLI INFERMI - SC Cardiologia

    Rivoli, Italy

  • OSPEDALE PIO XI - UOC di Cardiologia

    Desio, Italy

  • OSPEDALE SANTA CHIARA - Divisione di Cardiologia

    Trento, Italy

  • Ospedale Del Tigullio Polo Lavagna - Sc Cardiologia E Utic

    Lavagna, Italy

  • Ospedale Della Murgia - Fabio Perinei - S.C. Cardiologia-Utic

    Altamura, Italy

  • Ospedale Giovanni Paolo Ii - U.O.C. Cardiologia-Utic

    Ragusa, Italy

  • Ospedale Miulli - U.O.C. CARDIOLOGIA - UTIC

    Acquaviva delle Fonti, Italy

  • Ospedale Policlinico - Uoc Di Cardiologia

    Modena, Italy

  • Ospedale San Camillo - Uoc Cardiologia

    Roma, Italy

  • Ospedale San Donato - U.O.C Cardiologia

    Arezzo, Italy

  • Ospedale San Jacopo - Soc Cardiologia

    Pistoia, Italy

  • Ospedale San Paolo - Cardiologia-Utic

    Bari, Italy

  • Ospedale Santo Spirito - Cardiologia Con Utic

    Pescara, Italy

  • Ospedale Santo Spirito - SC Cardiologia

    Casale Monferrato, Italy

  • P.O. Levante - Ospedale San Paolo - S.C. Cardiologia Levante

    Savona, Italy

  • P.O. San Filippo Neri - Asl Roma 1 - Cardiologia Clinica E Riabilitativa

    Roma, Italy

  • PRESIDIO OSPEDALIERO - UO Cardiologia

    Sanremo, Italy

  • Po Santa Maria Nuova - Ausl Re Irccs - Soc Cardiologia Ospedaliera

    Reggio Emilia, Italy

  • Policlinico Riuniti - S.C. Di Cardiologia Universitaria-Utic

    Foggia, Italy

  • Presidio Ospedaliero "Santa Maria Del Prato" - U.O.C. Di Cardiologia-Utic

    Feltre, Italy

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