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CARotid plaqUe StabilizatiOn and Regression With Evolocumab.

NCT04730973 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2021-07-28

No results posted yet for this study

Summary

The CARUSO trial aims at investigating the efficacy of evolocumab in promoting carotid plaque morphological stabilization and regression as compared to traditional lipid lowering therapy (LLT). Primary end-point of the study is the superiority of evolocumab on top of ongoing LLT versus ongoing LLT in carotid plaque morphological stabilization and regression at 6 and 12 months, respectively. Secondary end-points are: LDL-Cholesterol (LDL-C) absolute and percentage changes in the two groups at 12 month follow-up, and adverse cerebrovascular and cardiac events at 12 and 24 months

Conditions

  • Carotid Artery Disease

Interventions

DRUG

Evolocumab

Evolocumab 140 mg s.c. every two weeks on top of optimal lipid lowering therapy

OTHER

lipid-lowering therapy (LLT)

lipid-lowering therapy (LLT)

Sponsors & Collaborators

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    lead OTHER

Principal Investigators

  • Tiziana Claudia Aranzulla, MD · A.O. Ordine Mauriziano di Torino

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04730973 on ClinicalTrials.gov