Efficacy and safety of Evoluocumab added Standard of Care in high cardiovascular risk haemodialized statin intolerant patients with hypercholesterolemia.

Phase IV study for efficacy and safety of Evolocumab added to Ezetimibe (Standard of Care) in high cardiovascular risk haemodialized statin intolerant patients with hypercholesterolemia. - EV01

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001491-11-IT

Enrollment

Registered

2021-05-24

Start date

2020-07-24

Completion date

Unknown

Last updated

2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High cardiovascular risk haemodialized statin intolerant patients with hypercholesterolemia. MedDRA version: 20.0 Level: HLGT Classification code 10013317 Term: Lipid metabolism disorders System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.0 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: SOC Classification code 10047065 Term: Vascular disorders System Organ Class: 100

Interventions

Trade Name: REPATHA - 140 MG- SOLUZIONE INIETTABILE- USO SOTTOCUTANEO- SIRINGA PRERIEMPITA (VETRO) (SURECLICK) 1 ML- 1 PENNA PRERIEMPITA Product Name: REPATHA Product Code: [C10AX13] Pharmaceutical Fo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients will be included in the study if all of the following criteria are met: - Age = 18; both genders. - High cardiovascular risk patients defined as: patients with established coronary heart disease (CHD), OR patients with CHD risk equivalents (ischemic stroke, peripheral artery disease, diabetes mellitus plus at least 2 additional risk factors); - Statin-intolerant patients with not adequately controlled LDL-C levels (=70 mg/dL) - Patients with uremia on periodic haemodialysis treatment. 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 25

Exclusion criteria

Exclusion criteria: - LDL-C <70 mg/dL - Age < 18 years.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary endpoint of this trial is to determine whether the treatment with a new therapeutic strategy (Evolocumab + Ezetimibe) is non-inferior to Ezetimibe alone, in reducing the LDL-C percentage from baseline to week 24, considering an ITT approach, in high cardiovascular risk statin-intolerant patients with hypercholesterolemia and ESRD, receiving maintenance haemodialysis.;Secondary Objective: To assess whether the new treatment with Evolocumab+Ezetimibe is non-inferior to usual therapy with Ezetimibe alone in terms of LDL-C reduction, comparing baseline measures versus 4, 12, 24 weeks measures; To evaluate the changes of other lipid parameters (HDL cholesterol, non-HDL cholesterol, triglycerides) from baseline to week 24 (ITT/on-treatment analysis); To evaluate the percentage of patients that reach the LDL-C < 70 mg/dL target at week 24 (ITT/on-treatment analysis); To evaluate the tolerability of Evolocumab, analyzing adverse events reports and laboratory values from the time of signed informed consent until the end of the study, and the hemodynamic stability during haemodialysis.;Primary end point(s): Observing in high cardiovascular risk statin-intolerant patients with hypercholesterolemia and ESRD, receiving maintenance haemodialysis, a LDL-C level reduction of at least 20 mg/dL;Timepoint(s) of evaluation of this end point: The survey will take place at the 24th week	—

Measure

Time frame

Main Objective: The primary endpoint of this trial is to determine whether the treatment with a new therapeutic strategy (Evolocumab + Ezetimibe) is non-inferior to Ezetimibe alone, in reducing the LDL-C percentage from baseline to week 24, considering an ITT approach, in high cardiovascular risk statin-intolerant patients with hypercholesterolemia and ESRD, receiving maintenance haemodialysis.;Secondary Objective: To assess whether the new treatment with Evolocumab+Ezetimibe is non-inferior to usual therapy with Ezetimibe alone in terms of LDL-C reduction, comparing baseline measures versus 4, 12, 24 weeks measures; To evaluate the changes of other lipid parameters (HDL cholesterol, non-HDL cholesterol, triglycerides) from baseline to week 24 (ITT/on-treatment analysis); To evaluate the percentage of patients that reach the LDL-C < 70 mg/dL target at week 24 (ITT/on-treatment analysis); To evaluate the tolerability of Evolocumab, analyzing adverse events reports and laboratory values from the time of signed informed consent until the end of the study, and the hemodynamic stability during haemodialysis.;Primary end point(s): Observing in high cardiovascular risk statin-intolerant patients with hypercholesterolemia and ESRD, receiving maintenance haemodialysis, a LDL-C level reduction of at least 20 mg/dL;Timepoint(s) of evaluation of this end point: The survey will take place at the 24th week

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Secondary

Measure	Time frame
Secondary end point(s): - To observe a LDL-C reduction comparing baseline measures versus 4, 12, 24 weeks measures, considering the new treatment with Evolocumab+Ezetimibe versus Ezetimibe alone; - To describe the changes of other lipid parameters (HDL cholesterol, non-HDL cholesterol, triglycerides) from baseline to week 24 (ITT/on-treatment analysis); - To observe the percentage of patients that reach the LDL-C < 70 mg/dL target at week 24 (ITT/on-treatment analysis). - To evaluate the tolerability of Evolocumab, analyzing adverse events reports and laboratory values from the time of signed informed consent until the end of the study, and the hemodynamic stability during haemodialysis.;Timepoint(s) of evaluation of this end point: The surveys will be carried out at 4,12 and 24 weeks	—

Measure

Time frame

Secondary end point(s): - To observe a LDL-C reduction comparing baseline measures versus 4, 12, 24 weeks measures, considering the new treatment with Evolocumab+Ezetimibe versus Ezetimibe alone; - To describe the changes of other lipid parameters (HDL cholesterol, non-HDL cholesterol, triglycerides) from baseline to week 24 (ITT/on-treatment analysis); - To observe the percentage of patients that reach the LDL-C < 70 mg/dL target at week 24 (ITT/on-treatment analysis). - To evaluate the tolerability of Evolocumab, analyzing adverse events reports and laboratory values from the time of signed informed consent until the end of the study, and the hemodynamic stability during haemodialysis.;Timepoint(s) of evaluation of this end point: The surveys will be carried out at 4,12 and 24 weeks

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Countries

Italy

Contacts

Public ContactDirezione scientifica

IRCCS San Raffaele Pisana

astrid.vanrijn@sanraffaele.it0652253405

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026