CARotid plaqUe StabilizatiOn and Regression With Evolocumab.

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera Ordine Mauriziano di Torino
• Treatments: Evolocumab

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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