primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia in atherosclerotic cardiovascular disease MedDRA version: 21.0 Level: LLT Classification code 10020604 Term: Hypercholesterolemia System Organ Class: 100000004861 MedDRA version: 20.0 Level: LLT Classification code 10054380 Term: Familial hypercholesterolemia System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10077966 Term: Primary hypercholesterolemia System Organ C
Conditions
Interventions
Trade Name: Leqvio
Pharmaceutical Form: Injection
Sponsors
Semmelweis University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female = 18 years of age at signing of informed consent. Written informed consent must be obtained before any assessment is performed. Subject agrees to the Maximum dose Statin therapy (Rosuvastatin min. 20 mg or Atorvastatin min. 40 mg) Fasting LDL-C local lab value at the Screening Visit = 1.8 mmol/L proved atherosclerotic coronary disease (at least 1 of the below): 1) non-obstructive coronary plaques on CT scan in the last 6 months without revascularization, at least in 4 four regions (1-69% stenosis is 2 regions and 25-69% stenosis in 2 other regions); 2)proved acute coronary syndrome in one year with multi-vessel disease (at least 50% stenosis on another artery; post-PCI patient with at least 2 coronary arteries involved Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: Pregnant or nursing (lactating) women. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception Ongoing malignancy at the time of the first study visit Renal insufficiency (eGFR <30 mL/min/1.73m2) as measured by the Modification of Diet in Renal Disease (MDRD) formula at the Screening Visit. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Screening Visit. Participants who enter must have AST and ALT =3x ULN Use of other investigational drugs within 5 half-lives of the first study visit (Screening Visit), within 30 days (e.g., small molecules), or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or if required by local regulations. COVID-19 vaccines granted Emergency Use Authorization are not considered investigational drugs for the purpose of this study. Heart failure New York Heart Association (NYHA) class IV at the Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show that a dicrease in LDL-level is achievable with establishing a complex, intensive lipid management program.;Secondary Objective: To assess the efficacy of the program in reaching LDL-target and plaque regression.;Primary end point(s): absolute and percent change in LDL-level from first to last visit (mmol/L) absolute and percent LDL-change from visit to visit ;Timepoint(s) of evaluation of this end point: Last visit (5th), at a mean of 21 months from start | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): change (from first to last visit) in percent of patients reaching LDL target (LDL<1.4 mmol/L) teljes plakk volumen változás; ún. „low-attenuation” plakk volumen változás; Agatston score változás; plakk kompozíció változás; perikoronariás és perikardiális zsírszövetmennyiség változása Ultrasound (femoral/carotid) endpoints: change in (from first to last visit): Total plaque area (mm2) Intima:media thickness plaque composition CCTA endpoints (for those entering with a former CTAA): Total plaque volume (mm3) Low attenuation plaque volume (%) Agatston – score plaque composition Change in BMI Change in lifestyle, diet and health behaviour ;Timepoint(s) of evaluation of this end point: Last visit (5th), at a mean of 21 months from start, and from visit to visit (1-3-9-15 months from start) | — |
Countries
Hungary
Contacts
Public ContactVSZÉK study coordinator
Semmelweis University
Outcome results
None listed