CARotid plaqUe StabilizatiOn and Regression With Evolocumab.

NCT04730973 | Unknown Phase 4

• 1 other identifier: 2020-005663-31
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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). 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

Outcome Measures

Primary Outcomes (2)

• Morphological carotid plaque stabilization

  Morphological stabilization of the carotid plaque evaluated with Carotid duplex ultra-sonography

  Six months

• Carotid plaque regression

  Carotid plaque regression evaluated with Carotid duplex ultra-sonography and defined as reduction of the entity of the stenosis and/or peak systolic velocity by at least 5%, as compared to baseline.

  12 months

Secondary Outcomes (2)

• Changes of LDL-C

  12 months

• Major adverse cerebrovascular events

  12 and 24 months

Study Arms (2)

Evolocumab

ACTIVE COMPARATOR

Subcutaneous evolocumab 140 mg will be administered every 2 weeks on top of optimal lipid-lowering therapy

Drug: Evolocumab; Other: lipid-lowering therapy (LLT)

Standard

PLACEBO COMPARATOR

No further treatment besides optimal lipid-lowering therapy will be administered

Other: lipid-lowering therapy (LLT)

Interventions

Evolocumab DRUG

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

Also known as: Repatha

Evolocumab

lipid-lowering therapy (LLT) OTHER

lipid-lowering therapy (LLT)

Evolocumab; Standard

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Ordine Mauriziano di Torino: lead

Study Sites (1)

Azienda Ospedaliera Ordine Mauriziano di Torino

Turin, Piedmont, 10134, Italy

RECRUITING

Related Publications (2)

• Aranzulla TC, Piazza S, Ricotti A, Musumeci G, Gaggiano A. CARotid plaqUe StabilizatiOn and regression with evolocumab: Rationale and design of the CARUSO study. Catheter Cardiovasc Interv. 2021 Jul 1;98(1):E115-E121. doi: 10.1002/ccd.29743. Epub 2021 Apr 24.

  PMID: 33893754 RESULT

• Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.

  PMID: 37565307 DERIVED

MeSH Terms

Conditions

Carotid Artery Diseases

Interventions

evolocumab

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tiziana Claudia Aranzulla, MD

  A.O. Ordine Mauriziano di Torino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiziana Claudia Aranzulla, MD

CONTACT

+390115085038; taranzulla@mauriziano.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single blinded study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Model Details: randomized controlled study

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: January 29, 2021
• Study Start: March 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)