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Acute Coronary SyndromesEARLYNCT07252388

EARLY: Educational Intervention to Improve Patient Awareness on Early LDL-C Lowering in Secondary Prevention

A study testing Patient-oriented educational intervention in people with Acute Coronary Syndromes and Chronic Coronary Syndromes, run by Heart Care Foundation at 30 sites in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Cluster Randomized Trial to test the effectiveness of a patient level delivered educational intervention to improve the awareness on the relevance of obtaining LDL cholesterol recommended goals in patients admitted for an acute coronary syndrome, as compared to usual care. Read more about this study

Who is it for?
Ages 18 to 79 years
What is being tested?
Patient-oriented educational intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
30 sitesItaly
Study dates
11 Dec 2025to 11 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 and <80 years old.
  • Males and females at birth.
  • 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)
  • Discharged at home
  • Ability to understand the requirements of the study and to provide informed consent

Who cannot join

  • Patients who have previously received or currently treated with PCSK9i (evolocumab or alirocumab) or siRNA (inclisiran)
  • Unstable clinical status (hemodynamic or electrical instability)
  • Uncontrolled cardiac arrhythmias, defined as recurrent, symptomatic ventricular tachycardia or atrial fibrillation or flutter with rapid ventricular response
  • Severe renal dysfunction, defined by eGFR < 30 mL/min/1.73 m2
  • 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.
  • 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.
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  • Treatment with systemic steroids or systemic cyclosporine within the past 3 months (e.g., intravenously, intramuscularly, or orally)
  • Known active infection or severe hematologic, metabolic, or endocrine dysfunction as judged by the Investigator.
  • Current inclusion in other pharmacological and non-pharmacological experimental studies.
  • 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.
  • 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.

Trial locations and contacts

30 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Leonardo De Luca, MD contact

+390555101355

early@heartcarefoundation.it

30 sites in 1 country

Italy30 sites

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

    Acquaviva delle Fonti, 70021

    Nicola Vitulano, MD, +39 0803054357, n.vitulano@miulli.it

    Nicola Vitulano, MD

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

    Ancona, 60122

    Matilda Shkoza, MD, +39 071 5965320, matilda.shkoza@ospedaliriuniti.marche.it

    Matilda Shkoza, MD

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

    Arzignano, 36071

    Claudio Bilato, MD, + 39 0444 479191-479106, claudio.bilato@aulss8.veneto.it

    Claudio Bilato, MD

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

    Benevento, 82100

    Marino Scherillo, MD, +39 0824 57679, marino.scherillo@gmail.com

    Marino Scherillo, MD

  • ARNAS G. Brotzu - Cardiologia con UTIC

    Cagliari, 09134

    Giulio Binaghi, MD, +39 070 539512, giulio.binaghi@aob.it

    Giulio Binaghi, MD

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

    Caserta, 81100

    Paolo Calabrò, MD, +39 0823 232352, paolo.calabro@unicampania.it

    Paolo Calabrò, MD

  • Azienda Ospedaliera Cannizzaro - UOC Cardiologia

    Catania, 95126

    Simona Giubilato, MD, +39 095 7264739, simogiub@hotmail.com

    Simona Giubilato, MD

  • Ospedale Maggiore - U.O. Cardiologia e UTIC

    Crema, 26013

    Sabato D'Amore, MD, +39 0373 280033-280097, sabato.damore@asst-crema.it

    Sabato D'Amore, MD

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

    Erice, 91016

    Giovanna Geraci, MD, +39 0923 809317, giovannageraci68@icloud.com

    Giovanna Geraci, MD

  • Ospedale Padre Antero Micone - SC Cardiologia - UTIC

    Genova, 16100

    Kevin Pisani, MD, +39 010 8498401-8498341, kevin.pisani@asl3.liguria.it

    Kevin Pisani, MD

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

    Genova, 16149

    Luisiana Pastorino, MD, +39 010 8492351, luisiana.pastorino@asl3.liguria.it

    Luisiana Pastorino, MD

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

    Livorno, 57124

    Emilio Maria Pasanisi, MD, +39 0586 223387, emiliomariagiovanni.pasanisi@uslnordovest.toscana.it

    Emilio Maria Pasanisi, MD

  • ASST Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica

    Milan, 20162

    Giovanna Viola, MD, +39 02 64441-64442308-2565, giovanna.viola@ospedaleniguarda.it

    Giovanna Viola, MD

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

    Monza, 20900

    Andrea Mauro, MD, +39 039 2333304, andrea.mauro@irccs-sangerardo.it

    Andrea Mauro, MD

  • AORN Cardarelli - U.O. Cardiologia con UTIC

    Naples, 80131

    Ciro Mauro, MD, +39 0817472808, ciro.mauro@aocardarelli.it

    Ciro Mauro, MD

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

    Orbassano, TO, 10043

    Carloalberto Biolè, MD, +39 011 9026701-9026706, c.biole@sanluigi.piemonte.it

    Carloalberto Biolè, MD

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

    Palermo, 90146

    Vincenzo Polizzi, MD, +39 091 7802692, v.polizzi@villasofia.it

    Vincenzo Polizzi, MD

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

    Palermo, 90146

    Maria Stella Scaccianoce, MD, +39 091 7808096, stellascaccia@gmail.com

    Maria Stella Scaccianoce, MD

  • Fondazione IRCCS Policlinico San Matteo - UOC Cardiologia

    Pavia, 27100

    Leonardo De Luca, MD, +39 0382 503157, l.deluca@smatteo.pv.it

    Leonardo De Luca, MD

  • Ospedale Santo Spirito - Cardiologia con UTIC

    Pescara, 65124

    Massimo Di Marco, MD, +39 085 4252526, massimo.dimarco@asl.pe.it

    Massimo Di Marco, MD

  • Ospedale Civile Guglielmo da Saliceto - UOC Cardiologia e UTIC

    Piacenza, 29100

    Daniela Aschieri, MD, +39 0523 303209-303215, d.aschieri@ausl.pc.it

    Daniela Aschieri, MD

  • Ospedale Santo Stefano - U.O. Cardiologia

    Prato, 59100

    Emilio Di Vincenzo, MD, +39 0574 803762, emilio.divincenzo@uslcentro.toscana.it

    Emilio Di Vincenzo, MD

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

    Reggio Emilia, 42100

    Alessandro Navazio, MD, +39 0522 296429, alessandro.navazio@ausl.re.it

    Alessandro Navazio, MD

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

    Roma, 00135

    Furio Colivicchi, MD, +39 06 33062429, furio.colivicchi@aslroma1.it

    Furio Colivicchi, MD

  • Ospedale San Camillo - UOC Cardiologia

    Roma, 00152

    Domenico Gabrielli, MD, +39 0658704419, dgabrielli@scamilloforlanini.rm.it

    Domenico Gabrielli, MD

  • Policlinico Casilino - U.O.C. Cardiologia

    Roma, 00169

    Germana Panattoni, MD, +39 06 23188205, gpanattoni@policlinicocasilino.it

    Germana Panattoni, MD

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

    Salerno, 84131

    Amelia Ravera, MD, +39 089 673136, amelia.ravera@sangiovannieruggi.it

    Amelia Ravera, MD

  • Ospedale SS. Annunziata - Cardiologia Clinica ed Interventistica

    Sassari, 07100

    Gavino Casu, MD, +39 079 2646120, gavino.casu@aouss.it

    Gavino Casu, MD

  • Ospedale Mauriziano Umberto I - SC Cardiologia

    Torino, TO, 10128

    Giuseppe Musumeci, MD, +39 011 5081111-5082515-2525, gmusumeci@mauriziano.it

    Giuseppe Musumeci, MD

  • Ospedale Belcolle - UOSD UTIC Polo

    Viterbo, 01100

    Francesco Serra, MD, +39 0761 339435, francesco.serra@asl.vt.it

    Francesco Serra, MD

Other trials in Italy

About this study

Official title: Educational Intervention for Patient's Awareness on eaRly LDL-C Lowering Using Novel Pharmacological Strategies in secondarY Prevention (EARLY)

Cluster Randomized Trial to test the effectiveness of a patient level delivered educational intervention to improve the awareness on the relevance of obtaining LDL cholesterol recommended goals in patients admitted for an acute coronary syndrome, as compared to usual care. Overall, 24 sites (Coronary Care Units) will be included in the study, 12 randomized to the intervention and 12 to usual care. Overall, 240 patients will be enrolled during an acute coronary syndrome hospitalization.

Read the detailed description

Elevated LDL cholesterol levels are associated with an increased risk of adverse events after an acute coronary syndrome. The higher the LDL cholesterol level at patients' admission for acute coronary syndrome, the greater the intensity of lipid-lowering treatment to be adopted to obtain the greatest benefits in terms of reduction of all-cause and cardiovascular mortality.

Despite European Society of Cardiology guideline recommendations to achieve low LDL cholesterol targets in patients with acute coronary syndrome (halving of baseline LDL cholesterol values and reaching LDL cholesterol values < 55 mg/dl or < 40 mg/dl in the case of a second event within two years of the first), this is unlikely to happen in clinical practice. Recent observational studies, such as the Da Vinci and Santorini, provide important insights into the practical management of lipid-lowering therapy in post-ACS patients in daily clinical practice, showing that only about 20% of high- or very-high-risk patients achieve guideline-recommended targets.

On the other hand, aggressive control of modifiable risk factors could prevent up to 80% of premature deaths related to cardiovascular disease. This underscores the importance of healthcare professionals in maximizing prevention efforts. Improvements in community health could prevent millions of serious cardiovascular events each year if properly implemented.

New therapies, such as PCSK9 inhibitors (monoclonal antibodies) or siRNA (inclisiran), offer an option for further and faster LDL cholesterol reduction during the peri- and post-acute coronary syndrome period, associated with a marked improvement in prognosis.

However, the use of these pharmacological strategies is currently quite limited in clinical practice. Several conditions account for the reduced "adherence" of clinicians and patients to the recommended therapies. Health disparities due to socioeconomic status, age, race, gender and cost, limited access to healthcare, perceived side effects associated with lipid-lowering therapies, health literacy and the presence of comorbidities, are all factors contributing to the suboptimal use of proposed therapies. Furthermore, clinical factors, including failure to identify patients requiring LDL cholesterol reassessment, insufficient monitoring, and clinical inertia have been associated with an insufficient use of lipid-lowering therapies.

Recently, the Italian Association of Hospital Cardiologists published a position paper on the treatment of hypercholesterolemia in patients with acute coronary syndrome. In the document, aimed at achieving the lipid targets outlined in the ESC/EAS 2019 guidelines more quickly than those currently recommended (from 8 weeks of the guidelines to 4 weeks of the Italian Association of Hospital Cardiologists document with a progressive and sustainable approach) and including new therapeutic options to reduce LDL cholesterol levels, a personalized therapeutic intervention based on LDL cholesterol levels at the time of hospital admission was proposed.

As a consequence, implementing lipid-lowering treatments early according to patients' clinical risk and the pharmacological options available to clinicians, while improving patients' awareness of cardiovascular risk, remains one of the primary objectives of the clinical cardiologist in secondary prevention.

Technology can effectively serve as an essential aid in achieving therapeutic targets. The introduction of dedicated applications could facilitate doctor-patient communication. On the basis of this evidence, the investigators designed the present study with the aim to evaluate if an educational intervention to improve the awareness on the relevance of obtaining LDL cholesterol recommended goals in patients with confirmed diagnosis of acute coronary syndrome, as compared to usual care can increase the proportion of patients at LDL cholesterol goal as suggested by 2019 ESC/EAS guidelines.

Being tested
Patient-oriented educational intervention
Keywords
educational intervention, Patient awareness, LDL cholesterol, Lipid lowering drugs, Acute Coronary Syndrome
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient-oriented educational interventionOther

    APP support

Study groups in NCT07252388
Study groupRoleWhat they receive
Quality-improvement educational interventionExperimentalPatients included in the interventional arm will be guided to download a smartphone App which will allow them: * To see a 3-minute animated video aimed at explaining in layman terminology the benefits of intensifying LDL cholesterol reduction therapy, gaps in prescribing, reasons for clinical inertia, and motivations for patients to achieve recommended targets. * To see a check-list intended to propose a conscious way of managing dyslipidemia by the patient in relation to the targets to be achieved. * To include the ongoing lipid lowering therapy and enter the control LDL cholesterol value evaluated during hospitalization and that patient will perform in the days preceding the all the follow-up visits showing if goal has been achieved.
Receives: Other: Patient-oriented educational intervention
Usual careNo interventionPatients followed in the centers randomized to the control arm will be managed by usual care in accordance with local clinical guidance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients achieving Guideline recommended LDL-Cholesterol goal

    To compare the rate of patients with acute coronary syndrome who achieve the 2019 European Society of Cardiology/European Atherosclerosis Society guideline recommended LDL-Cholesterol goal (<55 mg/dl or <40 mg/dl in patients with recurrent events in the previous 24 months despite maximal lipid lowering treatment) at 12 months in sites following the interventional education protocol versus those receiving usual care.

    Measured: 12 month

Secondary outcomes (5)

  1. LDL-Cholesterol variation

    Change in LDL-Cholesterol from baseline.

    Measured: 12 months

  2. Use of Injective Lipid Lowering Therapy

    Rate of patients who received PCSK9i inhibitors (monoclonal antibodies) or inclisiran during hospitalization (very fast track)

    Measured: 1 month

  3. Use of Injective Lipid Lowering Therapy

    Rate of patients who received PCSK9i inhibitors (monoclonal antibodies) or inclisiran during hospitalization (very fast track)

    Measured: 6 month

  4. Number of participants with lipid lowering treatments related adverse events

    In the eCRF at the 6-month follow-up visit discontinuation of lipid-lowering treatments will be recorded together with side effects most frequently associated with these treatments (e.g., arthralgia, limb pain, flu-like symptoms/malaise, myalgia, back pain, and elevated transaminases).

    Measured: 6 months

  5. Number of participants with lipid lowering treatments related adverse events

    In the eCRF at the 12-month follow-up visit discontinuation of lipid-lowering treatments will be recorded together with side effects most frequently associated with these treatments (e.g., arthralgia, limb pain, flu-like symptoms/malaise, myalgia, back pain, and elevated transaminases).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2025
  2. Study start11 Dec 2025 (estimated)
  3. Primary completion11 Aug 2027 (estimated)
  4. Study completion11 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster randomized trial
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07252388
Sponsor's protocol ID
K28
Acronym
EARLY
Status last verified
Nov 2025
First submitted
14 Nov 2025
Last updated
26 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • De Luca L, Riccio C, Navazio A, Valente S, Cipriani M, Corda M, De Nardo A, Francese GM, Napoletano C, Tizzani E, Roncon L, Caldarola P, Gulizia MM, Gabrielli D, Oliva F, Colivicchi F. ANMCO position paper on the management of hypercholesterolaemia in patients with acute coronary syndrome. Eur Heart J Suppl. 2023 May 18;25(Suppl D):D312-D322. doi: 10.1093/eurheartjsupp/suad100. eCollection 2023 May.

    PubMed 37213800

  • Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available.

    PubMed 31504418

  • Ray KK, Molemans B, Schoonen WM, Giovas P, Bray S, Kiru G, Murphy J, Banach M, De Servi S, Gaita D, Gouni-Berthold I, Hovingh GK, Jozwiak JJ, Jukema JW, Kiss RG, Kownator S, Iversen HK, Maher V, Masana L, Parkhomenko A, Peeters A, Clifford P, Raslova K, Siostrzonek P, Romeo S, Tousoulis D, Vlachopoulos C, Vrablik M, Catapano AL, Poulter NR; DA VINCI study. EU-Wide Cross-Sectional Observational Study of Lipid-Modifying Therapy Use in Secondary and Primary Care: the DA VINCI study. Eur J Prev Cardiol. 2021 Sep 20;28(11):1279-1289. doi: 10.1093/eurjpc/zwaa047.

    PubMed 33580789

  • Ray KK, Haq I, Bilitou A, Manu MC, Burden A, Aguiar C, Arca M, Connolly DL, Eriksson M, Ferrieres J, Laufs U, Mostaza JM, Nanchen D, Rietzschel E, Strandberg T, Toplak H, Visseren FLJ, Catapano AL; SANTORINI Study Investigators. Treatment gaps in the implementation of LDL cholesterol control among high- and very high-risk patients in Europe between 2020 and 2021: the multinational observational SANTORINI study. Lancet Reg Health Eur. 2023 Apr 5;29:100624. doi: 10.1016/j.lanepe.2023.100624. eCollection 2023 Jun.

    PubMed 37090089

  • Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.

    PubMed 37622654

Questions about this trial

What is this clinical trial studying?

A study testing Patient-oriented educational intervention in people with Acute Coronary Syndromes and Chronic Coronary Syndromes, run by Heart Care Foundation at 30 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Leonardo De Luca, MD (+390555101355, early@heartcarefoundation.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients achieving Guideline recommended LDL-Cholesterol goal (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07252388, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.

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