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Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque
Sponsor: Middle East North Africa Stroke and Interventional Neurotherapies Organization
Summary
CAROTID-STABILISE is a phase III, multicentre, randomised, double-blind, placebo-controlled trial evaluating whether alirocumab 150 mg subcutaneously every 2 weeks, added to high-intensity statin therapy, produces greater reduction in intraplaque haemorrhage (IPH) volume at 26 weeks compared with placebo in patients with recently symptomatic carotid stenosis of 50-69% harbouring IPH or lipid-rich necrotic core (LRNC) on high-resolution vessel-wall MRI. The study will enroll 280 participants across multiple centres with a 52-week extension for durability and clinical endpoints assessment.
Official title: Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Trial With High-Resolution Vessel-Wall MRI and Clinical Endpoints
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
280
Start Date
2027-07
Completion Date
2030-09
Last Updated
2026-05-14
Healthy Volunteers
No
Conditions
Interventions
Alirocumab
Alirocumab 150 mg subcutaneous injection every 2 weeks via pre-filled pen for 52 weeks. First dose given at randomisation visit under supervision. Self-administered or caregiver-administered at home for subsequent doses. Alirocumab is a fully human monoclonal antibody that inhibits PCSK9, leading to significant LDL-C reduction beyond that achieved with statins alone.
Placebo
Matched placebo subcutaneous injection every 2 weeks via pre-filled pen for 52 weeks. Visually identical to alirocumab injection. First dose given at randomisation visit under supervision. Self-administered or caregiver-administered at home for subsequent doses.
Atorvastatin
Atorvastatin 80 mg oral tablet once daily as background high-intensity statin therapy for both arms. Rosuvastatin 40 mg daily may be substituted if patient is intolerant to atorvastatin. Administered throughout the entire study duration (52 weeks).
Locations (14)
Alexandria University, Smouha University Comprehensive Stroke Center
Alexandria, Egypt
Ain Shams University
Cairo, Egypt
Cairo University
Cairo, Egypt
Neurology Department, Al-Azhar University
Cairo, Egypt
Amman Specialized IR Center
Amman, Jordan
Centre Hospitalier Universitaire Ibn Sina de Rabat
Rabat, Morocco
Aga Khan University
Karachi, Pakistan
Weill Cornell Medicine-Qatar
Doha, Qatar
King Khalid University
Abhā, Saudi Arabia
King Abdulaziz Medical City
Jeddah, Saudi Arabia
King Abdullah Medical City
Mecca, Saudi Arabia
Institut National de Neurologie
Tunis, Tunisia
Department of Neurology, Eskisehir Osmangazi University
Eskişehir, Turkey (Türkiye)
Neurology Department, Dr. Lutfi Kirdar City Hospital
Istanbul, Turkey (Türkiye)