Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Carotid Stenosis

In brief

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.

Key facts

Study ID

NCT07586540

Run by

Middle East North Africa Stroke and Interventional Neurotherapies Organization

People needed

280

Starts

2027-07-01

Expected to finish

2030-09-01

Last updated by the study team

2026-05-14

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 40 and ≤ 80 years
• Recently symptomatic (TIA, amaurosis fugax, or non-disabling ischaemic stroke with mRS ≤ 2) referable to a carotid territory within 28 days of randomisation
• Ipsilateral extracranial internal carotid artery stenosis of 50-69% by NASCET criteria on CTA or DSA
• HR-VW-MRI evidence of IPH (MPRAGE hyperintensity ≥150% of adjacent sternocleidomastoid) OR LRNC ≥ 10% of plaque volume in the symptomatic plaque
• On a stable dose of high-intensity statin (atorvastatin 40-80 mg or rosuvastatin 20-40 mg) for ≥ 4 weeks, or able and willing to initiate atorvastatin 80 mg daily at randomisation
• LDL-C ≥ 70 mg/dL (1.8 mmol/L) at screening
• Able to undergo 3T MRI (no contraindications)
• Provides written informed consent

You may not qualify if…

• Indication for urgent carotid revascularisation within 14 days per treating team
• Disabling stroke (mRS > 2) or NIHSS > 5 at randomisation
• Carotid stenosis ≥ 70% or occlusion
• Cardioembolic stroke source (atrial fibrillation, LV thrombus, endocarditis, PFO with high-risk features)
• Intracranial haemorrhage within 12 months or any history of symptomatic ICH
• eGFR < 30 mL/min/1.73 m²
• Active hepatobiliary disease or ALT/AST > 3x ULN
• Prior exposure to any PCSK9 inhibitor or inclisiran within 6 months
• Known hypersensitivity to alirocumab or excipients
• Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential
• Life expectancy < 24 months
• Participation in another interventional trial within 30 days
• Inability to comply with follow-up or MRI schedule

Where it is running

• 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)

Full record on ClinicalTrials.gov

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