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Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque (CAROTID-STABIL)

8 maggio 2026 aggiornato da: Ossama Mansour, Middle East North Africa Stroke and Interventional Neurotherapies Organization

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

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

BACKGROUND: Symptomatic carotid stenosis of 50-69% carries a 30-day recurrent-stroke risk of 5-8% and a 2-year risk of 15-20% on best medical therapy alone. A substantial proportion of patients are either surgically deferred or anatomically borderline where revascularisation benefit is debated. PCSK9 inhibitors have demonstrated carotid plaque regression, reduction in lipid-rich necrotic core, and reduction in arterial inflammation. However, no RCT has tested whether PCSK9 inhibition can reduce intraplaque haemorrhage or LRNC in symptomatic carotid plaque.

DESIGN: This is a phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group superiority trial with a 26-week primary endpoint assessment and a 52-week extension. Patients with recently symptomatic carotid stenosis (50-69%) with MRI-confirmed vulnerable plaque features (IPH or LRNC) will be randomised 1:1 to alirocumab 150 mg SC q2w or matched placebo, both on background high-intensity statin therapy.

PRIMARY ENDPOINT: Absolute change in IPH volume (mm³) from baseline to week 26, measured on MPRAGE sequences by a blinded central imaging core lab using semi-automated segmentation.

SECONDARY ENDPOINTS: Include percent change in LRNC volume, absolute change in minimum fibrous cap thickness, percent change in total plaque wall volume at weeks 26 and 52, composite of ipsilateral recurrent stroke or TIA through week 52, and proportion avoiding carotid revascularisation through week 52.

SAFETY: Monitored by an independent Data and Safety Monitoring Board (DSMB) with pre-specified interim analyses at 50% and 75% enrolment.

Tipo di studio

Interventistico

Iscrizione (Stimato)

280

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Arabia Saudita
      • Abhā, Arabia Saudita
        • King Khalid University
      • Jeddah, Arabia Saudita
        • King Abdulaziz Medical City
      • Mecca, Arabia Saudita
        • King Abdullah Medical City
  • Egitto
      • Alexandria, Egitto
        • Alexandria University, Smouha University Comprehensive Stroke Center
      • Cairo, Egitto
        • Cairo university
      • Cairo, Egitto
        • Ain shams university
      • Cairo, Egitto
        • Neurology Department, Al-Azhar University
  • Giordania
      • Amman, Giordania
        • Amman Specialized IR Center
  • Marocco
      • Rabat, Marocco
        • Centre Hospitalier Universitaire Ibn Sina de Rabat
  • Pakistan
      • Karachi, Pakistan
        • Aga Khan University
  • Qatar
      • Doha, Qatar
        • Weill Cornell Medicine-Qatar
  • Tunisia
      • Tunis, Tunisia
        • Institut National de Neurologie
  • Turchia (Türkiye)
      • Eskişehir, Turchia (Türkiye)
        • Department of Neurology, Eskisehir Osmangazi University
      • Istanbul, Turchia (Türkiye)
        • Neurology Department, Dr. Lutfi Kirdar City Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Alirocumab + High-Intensity Statin
Alirocumab 150 mg subcutaneous injection every 2 weeks via pre-filled pen, self-administered or caregiver-administered, from randomisation through week 52. Plus atorvastatin 80 mg daily (or rosuvastatin 40 mg if intolerant) as background therapy.
Droga: 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.
Droga: 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.
Droga: 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).
Comparatore placebo: Placebo + High-Intensity Statin
Matched placebo subcutaneous injection every 2 weeks via pre-filled pen from randomisation through week 52, visually identical to alirocumab. Plus atorvastatin 80 mg daily (or rosuvastatin 40 mg if intolerant) as background therapy.
Droga: 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.
Droga: 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.
Droga: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Absolute change in intraplaque haemorrhage (IPH) volume from baseline to week 26
Lasso di tempo: 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.
Baseline to 26 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent change in lipid-rich necrotic core (LRNC) volume at week 26
Lasso di tempo: Baseline to 26 weeks
Percent change in lipid-rich necrotic core volume from baseline to week 26, measured on high-resolution vessel-wall MRI by a blinded central imaging core laboratory.
Baseline to 26 weeks
Absolute change in minimum fibrous cap thickness at week 26
Lasso di tempo: Baseline to 26 weeks
Absolute change in minimum fibrous cap thickness (mm) from baseline to week 26, measured on post-contrast T1 black-blood MRI by a blinded central imaging core laboratory.
Baseline to 26 weeks
Percent change in total plaque wall volume at week 26
Lasso di tempo: Baseline to 26 weeks
Percent change in total plaque wall volume (outer wall area minus lumen area summed across all slices) from baseline to week 26, measured on high-resolution vessel-wall MRI by a blinded central imaging core laboratory.
Baseline to 26 weeks
Percent change in intraplaque haemorrhage (IPH) volume at week 52
Lasso di tempo: Baseline to 52 weeks
Percent change in intraplaque haemorrhage volume from baseline to week 52, measured on MPRAGE sequences by a blinded central imaging core laboratory.
Baseline to 52 weeks
Percent change in lipid-rich necrotic core (LRNC) volume at week 52
Lasso di tempo: Baseline to 52 weeks
Percent change in lipid-rich necrotic core volume from baseline to week 52, measured on high-resolution vessel-wall MRI by a blinded central imaging core laboratory.
Baseline to 52 weeks
Composite of ipsilateral recurrent ischaemic stroke or TIA through week 52
Lasso di tempo: Randomisation to 52 weeks
Time to first occurrence of ipsilateral recurrent ischaemic stroke or transient ischaemic attack (TIA) from randomisation through week 52, adjudicated by an independent blinded clinical events committee.
Randomisation to 52 weeks
Proportion of patients avoiding carotid revascularisation through week 52
Lasso di tempo: Randomisation to 52 weeks
Proportion of patients who do not undergo carotid revascularisation (carotid endarterectomy or carotid artery stenting) through 52 weeks from randomisation, adjudicated by an independent blinded clinical events committee.
Randomisation to 52 weeks

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Safety and tolerability composite
Lasso di tempo: Randomisation to 52 weeks
Composite safety endpoint including: serious adverse events, adverse events leading to discontinuation, injection-site reactions, new-onset diabetes, neurocognitive adverse events, frequency of LDL-C < 15 mg/dL and clinical correlates, haemorrhagic stroke, and major bleeding (BARC >= 3). Monitored continuously through 52 weeks.
Randomisation to 52 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Middle East North Africa Stroke and Interventional Neurotherapies Organization

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2027

Completamento primario (Stimato)

1 marzo 2030

Completamento dello studio (Stimato)

1 settembre 2030

Date di iscrizione allo studio

Primo inviato

8 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 maggio 2026

Primo Inserito (Effettivo)

14 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MENASINO-CAROTID-2026-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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