CARotid plaqUe StabilizatiOn and Regression With Evolocumab.

Carotid Artery Disease Clinical Trial

— CARUSO  

Official title:

CARotid plaqUe StabilizatiOn and Regression With Evolocumab: the CARUSO Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04730973
• Other study ID #: 2020-005663-31
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: July 2021
• Source: Azienda Ospedaliera Ordine Mauriziano di Torino
• Contact: Tiziana Claudia Aranzulla, MD
• Phone: +390115085038
• Email: taranzulla[@]mauriziano.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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, indeed, reduced in proportion to the achieved LDL cholesterol (LDL-C) levels.In addition, regression of atherosclerotic plaques with optimal LLT has been observed. However, optimal LLT with statin and ezetimibe, might be limited by the onset of adverse effects (i.e. disabling myalgias, diarrhea) with are usually dose -dependent, and the maximum tolerated statin dose might be insufficient to reach the recommended LDL-C goals. The advent of proprotein convertase subtilisin kexin type 9 inhibitors (PCSK9i) has allowed the achievement of very low LDL-C levels, and the fulfillment of the recommended LDL-C targets. However, while the experience with PCSK9i in patients with coronary artery disease has been wide, and coronary plaque regression has been documented, little is known regarding carotid plaque regression following therapy with PCSK9i. Only a few case reports have been published, and no observational study has been carried out so far. Furthermore, morphological carotid plaque stabilization has a prognostic role, and the possibility of its early achievement with PCSK9i may be relevant, especially in the context of percutaneous or surgical carotid interventions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carotid Artery Disease
• Carotid Artery Diseases

Intervention

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)

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Ordine Mauriziano di Torino	Torino	Piedmont

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Ordine Mauriziano di Torino

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphological carotid plaque stabilization	Morphological stabilization of the carotid plaque evaluated with Carotid duplex ultra-sonography	Six months
Primary	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	Changes of LDL-C	Absolute changes of LDL-C	12 months
Secondary	Major adverse cerebrovascular events	All-cause mortality, cardiovascular mortality, stroke, myocardial infarction, any coronary or peripheral revascularization	12 and 24 months