CARotid plaqUe StabilizatiOn and regression with evolocumab

CARotid plaqUe StabilizatiOn and regression with evolocumab) - CARUSO

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005663-31-IT

Enrollment

100

Registered

2021-06-04

Start date

2022-10-04

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

atherosclerosis desead MedDRA version: 20.0 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: REPATHA - 140 MG- SOLUZIONE INIETTABILE- USO SOTTOCUTANEO- SIRINGA PRERIEMPITA (VETRO) (SURECLICK) 1 ML- 1 PENNA PRERIEMPITA Product Name: REPATHA Product Code: [044317030] Pharmaceutical

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: asymptomatic patients with mono or bilateral carotid stenosis =50% and LDL-C values ¿¿=100 mg / dL despite LLT 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: to evaluate the morphological stabilization of the carotid plaque and its regression after 6 and 12 months of therapy with evolocumab;Secondary Objective: to evaluate the morphological stabilization of the carotid plaque and its regression after 6 and 12 months of therapy with evolocumab;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;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: to evaluate the morphological stabilization of the carotid plaque and its regression after 6 and 12 months of therapy with evolocumab;Secondary Objective: to evaluate the morphological stabilization of the carotid plaque and its regression after 6 and 12 months of therapy with evolocumab;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;Timepoint(s) of evaluation of this end point: 12 months

—

Secondary

Measure	Time frame
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;Timepoint(s) of evaluation of this end point: 12 months	—

Countries

Italy

Contacts

Public ContactUfficio Sperimentazioni

A.O. Ordine Mauriziano di Torino

sperimentazioni@mauriziano.it0115082293

Outcome results

None listed

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