CARotid plaqUe StabilizatiOn and Regression With Evolocumab.

Sponsor
Azienda Ospedaliera Ordine Mauriziano di Torino
Study ID
NCT04730973
Phase
PHASE4
Status
Unknown

Conditions

  • Carotid Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — DRUG
    Evolocumab 140 mg s.c. every two weeks on top of optimal lipid lowering therapy
  • lipid-lowering therapy (LLT) — OTHER
    lipid-lowering therapy (LLT)

Study Details

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

Key Dates

Start date
Mar 1, 2021
Status verified
Jul 2021
Primary completion
Mar 31, 2022
Completion
Mar 31, 2022

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Evolocumab
    Subcutaneous evolocumab 140 mg will be administered every 2 weeks on top of optimal lipid-lowering therapy
  • Placebo Comparator: Standard
    No further treatment besides optimal lipid-lowering therapy will be administered

Primary Outcome Measure

Morphological carotid plaque stabilization [ Time Frame: Six months ]

Central Contacts

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