Status:

UNKNOWN

CARotid plaqUe StabilizatiOn and Regression With Evolocumab.

Lead Sponsor:

Azienda Ospedaliera Ordine Mauriziano di Torino

Conditions:

Carotid Artery Disease

Eligibility:

All Genders

18-80 years

Phase:

PHASE4

Brief 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). Primar...

Detailed Description

Optimal lipid-lowering therapy (LLT) is a mainstay for the therapeutic management of atherosclerotic vascular disease. Cardiac and cerebrovascular adverse events and progression of atherosclerosis are...

Eligibility Criteria

Inclusion

  • asymptomatic patients with uni- or bilateral carotid artery stenosis ≥50% and LDL-C values ≥100 mg/dL despite ongoing lipid lowering therapy

Exclusion

  • age \<18 or ≥81 years old
  • known intolerance to evolocumab
  • ongoing or previous treatment with PCSK9i
  • prior stroke or transient ischemic attack
  • total carotid occlusion
  • major active infection or major hematologic, renal, hepatic, or endocrine dysfunction
  • malignancy with life expectancy below 24 months
  • failure to sign informed consent

Key Trial Info

Start Date :

March 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 31 2022

Estimated Enrollment :

130 Patients enrolled

Trial Details

Trial ID

NCT04730973

Start Date

March 1 2021

End Date

March 31 2022

Last Update

July 28 2021

Active Locations (1)

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Azienda Ospedaliera Ordine Mauriziano di Torino

Turin, Piedmont, Italy, 10134