E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
atherosclerosis desead |
MALATTIA ATEROSCLEROTICA |
|
E.1.1.1 | Medical condition in easily understood language |
atherosclerosis desead |
MALATTIA ATEROSCLEROTICA |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10007541 |
E.1.2 | Term | Cardiac disorders |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to evaluate the morphological stabilization of the carotid plaque and its regression after 6 and 12 months of therapy with evolocumab |
valutare la stabilizzazione morfologica della placca carotidea e la regressione di essa dopo 6 e 12 mesi di terapia con evolocumab, rispettivamente. |
|
E.2.2 | Secondary objectives of the trial |
to evaluate the morphological stabilization of the carotid plaque and its regression after 6 and 12 months of therapy with evolocumab |
valutare la stabilizzazione morfologica della placca carotidea e la regressione di essa dopo 6 e 12 mesi di terapia con evolocumab, rispettivamente. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
asymptomatic patients with mono or bilateral carotid stenosis =50% and LDL-C values ¿¿=100 mg / dL despite LLT |
pazienti asintomatici con stenosi carotidea mono o bilaterale di entità =50% e valori di C-LDL =100 mg/dL nonostante LLT |
|
E.4 | Principal exclusion criteria |
<18 years, known intolerance to evolocumab, previous or current therapy with PCSK9 inhibitors, previous stroke or TIA, total carotid occlusion, failure to sign informed consent. Other exclusion criteria are: major active infection or major haematological, renal, hepatic or endocrine disease, tumor disease with a life expectancy of less than 24 months. |
età <18 anni, nota intolleranza a evolocumab, pregressa o attuale terapia con inibitori del PCSK9, pregresso ictus o TIA, occlusione carotidea totale, mancata sottoscrizione del consenso informato. Altri criteri di esclusione sono: infezione attiva maggiore o malattia ematologica, renale, epatica o endocrina maggiore, malattia tumorale con aspettativa di vita inferiore a 24 mesi. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Superiority of evolocumab added to ongoing LLT versus ongoing LLT in determining morphological stabilization and regression of carotid plaque at 6 and 12 months, respectively |
Superiorità di evolocumab aggiunto alla LLT in corso versus la LLT in corso nel determinare la stabilizzazione morfologica e la regressione della placca carotidea, a 6 e 12 mesi, rispettivamente |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Absolute and percentage change in LDL cholesterol (LDL-C) levels in the two groups at 12 months of follow-up Cerebrovascular and cardiac adverse events at 12 and 24 months |
Modifica assoluta ed in percentuale dei livelli di colesterolo LDL (LDL-C) nei due gruppi a 12 mesi di follow-up Eventi avversi cerebrovascolari e cardiaci a 12 e 24 mesi |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
terapia standard (statine + ezetimibe) |
standard therapy (statin + ezetimibe) |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 12 |
E.8.9.2 | In all countries concerned by the trial days | 0 |