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NOT YET RECRUITING
NCT07586540
PHASE3

Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque

Sponsor: Middle East North Africa Stroke and Interventional Neurotherapies Organization

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.

DRUG

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)