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

NCT07252388 | Not Yet Recruiting

• 1 other identifier: K28
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 30

Brief 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. 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.

Conditions

Acute Coronary Syndromes; Chronic Coronary Syndromes

Keywords

educational intervention; Patient awareness; LDL cholesterol; Lipid lowering drugs; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (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.

  12 month

Secondary Outcomes (5)

• LDL-Cholesterol variation

  12 months

• Use of Injective Lipid Lowering Therapy

  1 month

• Use of Injective Lipid Lowering Therapy

  6 month

• Number of participants with lipid lowering treatments related adverse events

  6 months

• Number of participants with lipid lowering treatments related adverse events

  12 months

Other Outcomes (4)

• Cardiovascular death (explorative objective)

  12 month

• New hospitalizations for atherothrombotic events (explorative objective)

  12 month

• All-cause mortality (explorative objective)

  12 month

Study Arms (2)

Quality-improvement educational intervention

EXPERIMENTAL

Patients 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.

Other: Patient-oriented educational intervention

Usual care

NO INTERVENTION

Patients followed in the centers randomized to the control arm will be managed by usual care in accordance with local clinical guidance.

Interventions

Patient-oriented educational intervention OTHER

APP support

Quality-improvement educational intervention

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Heart Care Foundation: lead
• Novartis Farma S.p.A.: collaborator

Study Sites (30)

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

Orbassano, TO, 10043, Italy

Location

Ospedale Mauriziano Umberto I - SC Cardiologia

Torino, TO, 10128, Italy

Location

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

Acquaviva delle Fonti, 70021, Italy

Location

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

Ancona, 60122, Italy

Location

Ospedale Civile - U.O.C. di Cardiologia

Arzignano, 36071, Italy

Location

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

Benevento, 82100, Italy

Location

ARNAS G. Brotzu - Cardiologia con UTIC

Cagliari, 09134, Italy

Location

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

Caserta, 81100, Italy

Location

Azienda Ospedaliera Cannizzaro - UOC Cardiologia

Catania, 95126, Italy

Location

Ospedale Maggiore - U.O. Cardiologia e UTIC

Crema, 26013, Italy

Location

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

Erice, 91016, Italy

Location

Ospedale Padre Antero Micone - SC Cardiologia - UTIC

Genova, 16100, Italy

Location

Ospedale Villa Scassi - ASL 3 Ligure - SC Cardiologia UTIC

Genova, 16149, Italy

Location

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

Livorno, 57124, Italy

Location

ASST Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica

Milan, 20162, Italy

Location

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

Monza, 20900, Italy

Location

AORN Cardarelli - U.O. Cardiologia con UTIC

Napoli, 80131, Italy

Location

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

Palermo, 90146, Italy

Location

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

Palermo, 90146, Italy

Location

Fondazione IRCCS Policlinico San Matteo - UOC Cardiologia

Pavia, 27100, Italy

Location

Ospedale Santo Spirito - Cardiologia con UTIC

Pescara, 65124, Italy

Location

Ospedale Civile Guglielmo da Saliceto - UOC Cardiologia e UTIC

Piacenza, 29100, Italy

Location

Ospedale Santo Stefano - U.O. Cardiologia

Prato, 59100, Italy

Location

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

Reggio Emilia, 42100, Italy

Location

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

Roma, 00135, Italy

Location

Ospedale San Camillo - UOC Cardiologia

Roma, 00152, Italy

Location

Policlinico Casilino - U.O.C. Cardiologia

Roma, 00169, Italy

Location

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

Salerno, 84131, Italy

Location

Ospedale SS. Annunziata - Cardiologia Clinica ed Interventistica

Sassari, 07100, Italy

Location

Ospedale Belcolle - UOSD UTIC Polo

Viterbo, 01100, Italy

Location

Related Publications (5)

• 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.

  PMID: 37213800 BACKGROUND

• 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.

  PMID: 31504418 BACKGROUND

• 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.

  PMID: 33580789 BACKGROUND

• 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.

  PMID: 37090089 BACKGROUND

• 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.

  PMID: 37622654 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Leonardo De Luca, MD

CONTACT

+390555101355; early@heartcarefoundation.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized trial

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 26, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): August 11, 2027
• Study Completion (Estimated): August 11, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (30)