Clinical trial • Cardiology

Evolocumab for Carotid artery stenosis

Clinical trial of Evolocumab for Carotid artery stenosis.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Carotid artery stenosis
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
23-12-2024
First CTIS Authorization Date
29-01-2025

Trial design

Randomised, open-label, ongoing lipid-lowering therapy (llt) alone; no specific drug, dose, or schedule specified-controlled trial across 1 site in Italy.

Randomised
Yes
Open Label
Yes
Comparator
Ongoing lipid-lowering therapy (LLT) alone; no specific drug, dose, or schedule specified
Target Sample Size
100
Trial Duration For Participant
730

Eligibility

Recruits 100 Vulnerable population not selected; informed consent is required and lack of consent excludes participation. Consent is obtained at screening and reconfirmed during treatment visits..

Vulnerable Population
Vulnerable population not selected; informed consent is required and lack of consent excludes participation. Consent is obtained at screening and reconfirmed during treatment visits.

Inclusion criteria

  • {"criterion_text":"- asymptomatic patients with carotid stenosis mono or bilateral magnitude ≥50% and LDL-C values ​​≥100 mg/dL despite maximal LLT..."}

Exclusion criteria

  • {"criterion_text":"- 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 endpoints

  • {"endpoint_text":"- Superiority of evolocumab added to ongoing LLT versus ongoing LLT in determining morphological stabilization and carotid plaque regression, at 6 and 12 months, respectively","definition_or_measurement_approach":"Morphological stabilization at 6 months: regression of 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. Regression at 12 months: reduction in the extent of stenosis and PSV of at least 5% compared to baseline values."}

Other endpoints

  • {"endpoint_text":"- evaluate the absolute and percentage change in LDL-C values ​​in the two groups at 12 months follow-up","definition_or_measurement_approach":"Absolute and percentage change in LDL-C at 12 months compared to baseline."}

Recruitment

Planned Sample Size
100
Recruitment Window Months
48
Consent Approach
Informed consent is obtained at screening for eligible patients and reconfirmed during treatment visits. Non-subscription of informed consent is an exclusion criterion. A subject information and informed consent document is listed in the trial documents.

Geography

Total Number Of Sites
1
Total Number Of Participants
100

Italy

Earliest CTIS Part Ii Submission Date
23-01-2025
Latest Decision Or Authorization Date
29-01-2025
Processing Time Days
6
Number Of Sites
1
Number Of Participants
100

Sites

Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
Cardiologia
Principal Investigator Name
Tiziana Aranzulla
Principal Investigator Email
taranzulla@mauriziano.it
Contact Person Name
Tiziana Aranzulla
Contact Person Email
taranzulla@mauriziano.it

Sponsor

Primary sponsor

Full Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
Repatha 140 mg solution for injection in pre-filled syringe
Active Substance
Evolocumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
Route
Intravenous or Subcutaneous
Authorisation Status
Authorised (marketing authorisation: EU/1/15/1016/001)
Starting Dose
140 mg
Maximum Dose
140 mg
Combination Treatment
Yes

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