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Clinical Trials in Italy / NCT07252388
Starting soon Not applicable

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

NCT07252388 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-12-11
Last updated
2025-11-26

Condition(s) studied

Acute Coronary SyndromesChronic Coronary Syndromes

Investigational drug(s) / intervention(s)

Patient-oriented educational intervention

Patient-oriented educational intervention: APP support

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
79 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (30)

FacilityCityRegionStatus
AOU San Luigi Gonzaga - S.C.D.O. Cardiologia Orbassano TO
Ospedale Mauriziano Umberto I - SC Cardiologia Torino TO
Ospedale Miulli - U.O.C. Cardiologia - UTIC Acquaviva delle Fonti Italy
A.O.U. delle Marche - Cardiologia Ospedaliera e UTIC Ancona Italy
Ospedale Civile - U.O.C. di Cardiologia Arzignano Italy
Azienda Ospedaliera San Pio-PO G. Rummo - Cardiologia Interventistica e UTIC Benevento Italy
ARNAS G. Brotzu - Cardiologia con UTIC Cagliari Italy
Azienda Ospedaliera S. Anna e S. Sebastiano - U.O. Cardiologia d'Emergenza con UTIC Caserta Italy
Azienda Ospedaliera Cannizzaro - UOC Cardiologia Catania Italy
Ospedale Maggiore - U.O. Cardiologia e UTIC Crema Italy
PO S. Antonio Abate di Trapani - U.O.C. di Cardiologia, UTIC ed Emodinamica Erice Italy
Ospedale Padre Antero Micone - SC Cardiologia - UTIC Genova Italy
Ospedale Villa Scassi - ASL 3 Ligure - SC Cardiologia UTIC Genova Italy
Ospedali Riuniti - U.O.C. Cardiologia e UTIC Livorno Italy
ASST Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica Milan Italy
Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia Monza Italy
AORN Cardarelli - U.O. Cardiologia con UTIC Naples Italy
AOR Villa Sofia-Cervello P.O. Cervello - U.O. Cardiologia - Cervello Palermo Italy
AOR Villa Sofia-Cervello PO Villa Sofia - UOC Cardiologia e UTIC e Emodinamica-Villa Sofia Palermo Italy
Fondazione IRCCS Policlinico San Matteo - UOC Cardiologia Pavia Italy
Ospedale Santo Spirito - Cardiologia con UTIC Pescara Italy
Ospedale Civile Guglielmo da Saliceto - UOC Cardiologia e UTIC Piacenza Italy
Ospedale Santo Stefano - U.O. Cardiologia Prato Italy
PO Santa Maria Nuova - AUSL RE IRCCS - SOC Cardiologia Ospedaliera Reggio Emilia Italy
P.O. San Filippo Neri - ASL ROMA 1 - Cardiologia Clinica e Riabilitativa Roma Italy
Ospedale San Camillo - UOC Cardiologia Roma Italy
Policlinico Casilino - U.O.C. Cardiologia Roma Italy
AOU S. Giovanni Di Dio-Ruggi D'Aragona - SSD UTIC Salerno Italy
Ospedale SS. Annunziata - Cardiologia Clinica ed Interventistica Sassari Italy
Ospedale Belcolle - UOSD UTIC Polo Viterbo Italy

More Heart Care Foundation trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07252388 on ClinicalTrials.gov ↗ ← All trials in Italy