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

Korábbi kezelés

• Patients who have previously received or currently treated with PCSK9i (evolocumab or alirocumab) or siRNA (inclisiran)
• Treatment with systemic steroids or systemic cyclosporine within the past 3 months (e.g., intravenously, intramuscularly, or orally)
• 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.

Más betegség

• Uncontrolled cardiac arrhythmias, defined as recurrent, symptomatic ventricular tachycardia or atrial fibrillation or flutter with rapid ventricular response
• 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:

Laborértékek

• 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.

Egyéb

• Unstable clinical status (hemodynamic or electrical instability)
• 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.
• Current inclusion in other pharmacological and non-pharmacological experimental studies.
• 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.

• 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