CARotid plaqUe StabilizatiOn and Regression With Evolocumab.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Carotid Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled study

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Single blinded study

Study Groups

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Evolocumab

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

Group Type ACTIVE_COMPARATOR

Evolocumab

Intervention Type DRUG

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

lipid-lowering therapy (LLT)

Intervention Type OTHER

lipid-lowering therapy (LLT)

Standard

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

Group Type PLACEBO_COMPARATOR

lipid-lowering therapy (LLT)

Intervention Type OTHER

lipid-lowering therapy (LLT)

Interventions

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Evolocumab

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

Intervention Type DRUG

lipid-lowering therapy (LLT)

Intervention Type OTHER

Other Intervention Names

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Repatha

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No