CARotid plaqUe StabilizatiOn and regression with evolocumab

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites · Protocol CARUSO

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)

Status Authorised, recruitment pending

Participants planned 100

Countries 1

Sites 1

carotid stenosis

Key facts

Sponsor: Azienda Ospedaliera Ordine Mauriziano Di Torino
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Decision date (initial): 2025-01-29
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2024-518566-27-00
EudraCT number: 2020-005663-31

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

evaluate the superiority of evolocumab in addition to ongoing LLT
compared to LLT alone with regards to:
a) morphological stabilization of the carotid plaque at 6 months, defined as regression of the
ulcerations and "soft" components and obtaining a regular morphology of the
plaque with prevalence of fibrous atheroma (type III and IV), evaluated with DUS and/or MRI, or CT
b) regression of the carotid plaque at 12 months, defined as reduction in the extent of
stenosis and PSV of at least 5% compared to baseline values.

Secondary objectives 1

evaluate the absolute and percentage change in LDL-C values in the two groups at 12 months follow-up

Conditions and MedDRA coding

carotid stenosis

Study design 3 periods

#	Title	Allocation	Blinding
1	Screening the investigator takes the medical history, the blood chemistry tests are viewed and in particular the LDL-C values and the carotid DUS is performed. The criteria are checked inclusion and exclusion and if the patient is eligible, informed consent is obtained and yes 6 proceeds to the randomization which, as already specified, occurs through randomization lists which are consulted after obtaining informed consent.	Randomised Controlled	None
2	Treatment the treatment regarding the study will last 12 months. At six months and 12 months the clinical evaluation will be repeated, the viewing of the blood chemistry tests (total cholesterol, LDL-C, HDL-C, triglycerides, blood count, blood sugar, GOT, GPT, CPK, creatinine) and Doppler ultrasound performed carotid. During the treatment period, all possible adverse events are evaluated related to therapy (allergic reactions or gastrointestinal or hepatic intolerance to evolocumab) which cardiac and cerebrovascular ones (mortality from all causes, cardiovascular mortality, stroke, myocardial infarction, any cardiac or peripheral revascularization). He will come during the visits consent to participate in the study was reconfirmed. The occurrence of serious adverse events and the revocation of consent will be the criteria for elimination from the study	Not Applicable	None
3	Follow up the study ends 12 months after enrollment, but the patient will be followed for up to 24 months including telephone contact with his treating doctors.	Not Applicable	None

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

asymptomatic patients with carotid stenosis mono or bilateral magnitude ≥50% and LDL-C values ≥100 mg/dL despite maximal LLT...

Exclusion criteria 1

age <18 years, known intolerance to evolocumab, previous or current therapy with PCSK9 inhibitors, previous stroke or TIA, total carotid occlusion, non-subscription of informed consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Superiority of evolocumab added to ongoing LLT versus ongoing LLT in determining morphological stabilization and carotid plaque regression, at 6 and 12 months, respectively

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Repatha 140 mg solution for injection in pre-filled syringe

PRD3018595 · Product

Active substance: Evolocumab
Substance synonyms: AMG145
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
Max daily dose: 140 1X 100 milligrams/millilitre
Max total dose: 140 1X 100 milligrams/millilitre
Max treatment duration: 112 Week(s)
Authorisation status: Authorised
ATC code: C10AX13 — -
Marketing authorisation: EU/1/15/1016/001
MA holder: AMGEN EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Ospedaliera Ordine Mauriziano Di Torino

Sponsor organisation: Azienda Ospedaliera Ordine Mauriziano Di Torino
Address: Via Ferdinando Magellano 1
City: Turin
Postcode: 10128
Country: Italy

Scientific contact point

Organisation: Azienda Ospedaliera Ordine Mauriziano Di Torino
Contact name: Clinical Trial Unit

Public contact point

Organisation: Azienda Ospedaliera Ordine Mauriziano Di Torino
Contact name: Clinical Trial Unit

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Italy	Authorised, recruitment pending	100	1
Rest of world	—	0	—

Investigational sites

Italy

1 site · Authorised, recruitment pending

Azienda Ospedaliera Ordine Mauriziano Di Torino

Cardiologia, Via Ferdinando Magellano 1, 10128, Turin

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	protocollo CARUSO	1
Recruitment arrangements (for publication)	NA	1
Subject information and informed consent form (for publication)	Informativa v1 25112020	1
Summary of Product Characteristics (SmPC) (for publication)	RCP EVOLOCUMAB	1
Summary of Product Characteristics (SmPC) (for publication)	RCP EZETIMIBE	1
Summary of Product Characteristics (SmPC) (for publication)	RCP ROSUVASTATINA	1
Synopsis of the protocol (for publication)	SINOSSI CARUSO	1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-12-23	Italy	Acceptable 2025-01-24	2025-01-29