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Heart attack survivors get a digital coach to slash cholesterol

NCT ID NCT07252388

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether an educational smartphone app can help people who have had a heart attack or other acute coronary event achieve their LDL cholesterol targets. About 240 patients across 24 hospitals will be randomly assigned to use the app or receive usual care. The main goal is to see if more app users reach the recommended LDL level below 55 mg/dL after 12 months.

What this could mean

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

Active substance
educational app (patient-oriented educational intervention)
What this could lead to
If it works, this could show that a simple educational app helps heart patients better manage their cholesterol and reduce future heart risks.
What could go wrong
This is an early-stage trial testing an educational tool, not a drug. The effect may be small, and results may not apply to all heart 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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 240 people

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

Expected to start

Dec 2025

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 to 79 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: 1. Age ≥18 and \<80 years old. 2. Males and females at birth. 3. Baseline LDL-Cholesterol: * ≥ 130 mg/dl (in statin-naïve patients or who have not followed a stable (unchanged) statin regimen for at least 4 weeks prior to enrollment) or * ≥110 mg/dl (in patients who have received stable moderate-intensity or low-intensity statin treatment in the 4 weeks prior to enrollment) or * ≥100 mg/dl (in patients who have received stable treatment with high-intensity statins in the 4 weeks prior to enrollment) 4. Discharged at home 5. Ability to understand the requirements of the study and to provide informed consent Exclusion Criteria: 1. Patients who have previously received or currently treated with PCSK9i (evolocumab or alirocumab) or siRNA (inclisiran) 2. Unstable clinical status (hemodynamic or electrical instability) 3. Uncontrolled cardiac arrhythmias, defined as recurrent, symptomatic ventricular tachycardia or atrial fibrillation or flutter with rapid ventricular response 4. Severe renal dysfunction, defined by eGFR \< 30 mL/min/1.73 m2 5. Active liver disease or liver dysfunction, reported in the medical record or defined by AST or ALT levels \> 3 times the upper limit of normal. 6. Reported intolerance to statins defined by the following criteria: inability to tolerate at least two different statins; intolerance associated with confirmed and intolerable statin-related adverse effects or significant biomarker abnormalities; improvement/resolution of symptoms or biomarkers following dose decrease or discontinuation; symptoms or changes in biomarkers not attributable to established predispositions. 7. Treatment with systemic steroids or systemic cyclosporine within the past 3 months (e.g., intravenously, intramuscularly, or orally) 8. Known active infection or severe hematologic, metabolic, or endocrine dysfunction as judged by the Investigator. 9. Current inclusion in other pharmacological and non-pharmacological experimental studies. 10. Pregnancy. For women of childbearing potential (age \< 50 years and last menses \<12 months prior to screening) who have not undergone tubal ligation, oophorectomy, or hysterectomy, pregnancy will be excluded from a pregnancy test prior to inclusion in the study. 11. Active neoplasia or very severe disease compromising short-medium term life expectancy. Only for sites randomized to the interventional group: • Patients without a device suitable for App use (eg. Smartphone or tablet) or patients that do not consent to receive push notifications by the App.

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome

As listed by the trial registrant

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

Acute coronary syndromes Chronic coronary syndromes

How to take part

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

  1. The places running it

    30 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

  • A.O.U. delle Marche - Cardiologia Ospedaliera e UTIC

    Ancona, 60122, Italy

  • AOR Villa Sofia-Cervello P.O. Cervello - U.O. Cardiologia - Cervello

    Palermo, 90146, Italy

  • AOR Villa Sofia-Cervello PO Villa Sofia - UOC Cardiologia e UTIC e Emodinamica-Villa Sofia

    Palermo, 90146, Italy

  • AORN Cardarelli - U.O. Cardiologia con UTIC

    Naples, 80131, Italy

  • AOU S. Giovanni Di Dio-Ruggi D'Aragona - SSD UTIC

    Salerno, 84131, Italy

  • AOU San Luigi Gonzaga - S.C.D.O. Cardiologia

    Orbassano, TO, 10043, Italy

  • ARNAS G. Brotzu - Cardiologia con UTIC

    Cagliari, 09134, Italy

  • ASST Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica

    Milan, 20162, Italy

  • Azienda Ospedaliera Cannizzaro - UOC Cardiologia

    Catania, 95126, Italy

  • Azienda Ospedaliera S. Anna e S. Sebastiano - U.O. Cardiologia d'Emergenza con UTIC

    Caserta, 81100, Italy

  • Azienda Ospedaliera San Pio-PO G. Rummo - Cardiologia Interventistica e UTIC

    Benevento, 82100, Italy

  • Fondazione IRCCS Policlinico San Matteo - UOC Cardiologia

    Pavia, 27100, Italy

  • Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia

    Monza, 20900, Italy

  • Ospedale Belcolle - UOSD UTIC Polo

    Viterbo, 01100, Italy

  • Ospedale Civile - U.O.C. di Cardiologia

    Arzignano, 36071, Italy

  • Ospedale Civile Guglielmo da Saliceto - UOC Cardiologia e UTIC

    Piacenza, 29100, Italy

  • Ospedale Maggiore - U.O. Cardiologia e UTIC

    Crema, 26013, Italy

  • Ospedale Mauriziano Umberto I - SC Cardiologia

    Torino, TO, 10128, Italy

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

    Acquaviva delle Fonti, 70021, Italy

  • Ospedale Padre Antero Micone - SC Cardiologia - UTIC

    Genova, 16100, Italy

  • Ospedale SS. Annunziata - Cardiologia Clinica ed Interventistica

    Sassari, 07100, Italy

  • Ospedale San Camillo - UOC Cardiologia

    Roma, 00152, Italy

  • Ospedale Santo Spirito - Cardiologia con UTIC

    Pescara, 65124, Italy

  • Ospedale Santo Stefano - U.O. Cardiologia

    Prato, 59100, Italy

  • Ospedale Villa Scassi - ASL 3 Ligure - SC Cardiologia UTIC

    Genova, 16149, Italy

  • Ospedali Riuniti - U.O.C. Cardiologia e UTIC

    Livorno, 57124, Italy

  • P.O. San Filippo Neri - ASL ROMA 1 - Cardiologia Clinica e Riabilitativa

    Roma, 00135, Italy

  • PO S. Antonio Abate di Trapani - U.O.C. di Cardiologia, UTIC ed Emodinamica

    Erice, 91016, Italy

  • PO Santa Maria Nuova - AUSL RE IRCCS - SOC Cardiologia Ospedaliera

    Reggio Emilia, 42100, Italy

  • Policlinico Casilino - U.O.C. Cardiologia

    Roma, 00169, Italy

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