Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque

NCT07586540 · tracked via the Priya Life Science Turkey tracker

Sponsor

Middle East North Africa Stroke and Interventional Neurotherapies Organization

Phase

Phase 3

Started

2027-07

Last updated

2026-05-14

Condition(s) studied

Carotid Stenosis

Investigational drug(s) / intervention(s)

Alirocumab →PlaceboAtorvastatin →

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).

Study 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.

Eligibility

Sex

ALL

Min age

40 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. Age ≥ 40 and ≤ 80 years 2. Recently symptomatic (TIA, amaurosis fugax, or non-disabling ischaemic stroke with mRS ≤ 2) referable to a carotid territory within 28 days of randomisation 3. Ipsilateral extracranial internal carotid artery stenosis of 50-69% by NASCET criteria on CTA or DSA 4. HR-VW-MRI evidence of IPH (MPRAGE hyperintensity ≥150% of adjacent sternocleidomastoid) OR LRNC ≥ 10% of plaque volume in the symptomatic plaque 5. 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 6. LDL-C ≥ 70 mg/dL (1.8 mmol/L) at screening 7. Able to undergo 3T MRI (no contraindications) 8. Provides written informed consent Exclusion Criteria: 1. Indication for urgent carotid revascularisation within 14 days per treating team 2. Disabling stroke (mRS \> 2) or NIHSS \> 5 at randomisation 3. Carotid stenosis ≥ 70% or occlusion 4. Cardioembolic stroke source (atrial fibrillation, LV thrombus, endocarditis, PFO with high-risk features) 5. Intracranial haemorrhage within 12 months or any history of symptomatic ICH 6. eGFR \< 30 mL/min/1.73 m² 7. Active hepatobiliary disease or ALT/AST \> 3x ULN 8. Prior exposure to any PCSK9 inhibitor or inclisiran within 6 months 9. Known hypersensitivity to alirocumab or excipients 10. Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential 11. Life expectancy \< 24 months 12. Participation in another interventional trial within 30 days 13. Inability to comply with follow-up or MRI schedule

Primary outcome measure(s)

Absolute change in intraplaque haemorrhage (IPH) volume from baseline to week 26 — Baseline to 26 weeks
Absolute change in intraplaque haemorrhage volume (mm³) from baseline to week 26, measured on MPRAGE sequences by a blinded central imaging core laboratory using semi-automated segmentation. IPH is defined as hyperintensity ≥150% of adjacent sternocleidomastoid muscle signal on 3T MRI.

Trial sites (14)

Facility	City	Region
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)

On this site

📄 Praluent (alirocumab) drug profile → 📄 Lipitor (atorvastatin) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07586540 on ClinicalTrials.gov ↗ ← All trials in Turkey