Trial intelligence / Profile preview

Alirocumab in Asymptomatic Intracranial Atherosclerotic Stenosis

NCT06080256Phase 3

Key facts

Status: Not yet recruiting
Start: Dec 2023
Primary completion: Dec 2024
Countries: 1
Sponsor: Jiangsu Provincial People's Hospital
Modality: Monoclonal Antibodies

Drugs: alirocumab
Conditions: intracranial atherosclerosis (ICAD)

Overview

Phase 3, randomised, open-label trial of alirocumab in intracranial atherosclerosis (ICAD) (2 arms), sponsored by Jiangsu Provincial People's Hospital. Primary endpoints: Plaque burden (PB) at 6 months, Degree of stenosis caused by the plaque at 6 months and 5 more. Planned start Dec 2023; status: not yet recruiting.

Design

2 arms

Study design: RandomizedOpen-label

Alirocumab + Statin
Alirocumab (75 mg every 2 weeks) added to statin (Atorvastatin 20-40mg)
Statin
Atorvastatin 20-40mg

Who it enrols

Patients aged 30-75 with 50-99% asymptomatic intracranial atherosclerotic stenosis, no recent stroke/TIA (<12 months), and no prior stenting/angioplasty of the target lesion.

Endpoints

Primary

Plaque burden (PB)6 months
Degree of stenosis caused by the plaque6 months
Plaque enhancement6 months
Remodeling index (RI) of the plaque6 months
Presence of T1 hyperintensity in the plaque6 months

Secondary

Any stroke (ischemic or hemorrhagic) or death6 months
Changes in LDL-cholesterol levels6 months

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