Carotid Artery Disease Clinical Trial
— CARUSOOfficial title:
CARotid plaqUe StabilizatiOn and Regression With Evolocumab: the CARUSO Study
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
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliera Ordine Mauriziano di Torino | Torino | Piedmont |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Ordine Mauriziano di Torino |
Italy,
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
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 |
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