Health Trials

Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque

ConditionCarotid Stenosis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-80
SponsorMiddle East North Africa Stroke and Interventional Neurotherapies Organization

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Alirocumab

    Drug

    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

    Drug

    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

    Drug

    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).

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: Alirocumab + High-Intensity StatinExperimental treatment 3 interventions
Group B: Placebo + High-Intensity StatinPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Absolute change in intraplaque haemorrhage (IPH) volume from baseline to week 26

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.

Time frame
Baseline to 26 weeks

Secondary outcomes

1

Percent change in lipid-rich necrotic core (LRNC) volume at week 26

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.

Time frame
Baseline to 26 weeks
2

Absolute change in minimum fibrous cap thickness at week 26

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.

Time frame
Baseline to 26 weeks
3

Percent change in total plaque wall volume at week 26

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.

Time frame
Baseline to 26 weeks
4

Percent change in intraplaque haemorrhage (IPH) volume at week 52

Percent change in intraplaque haemorrhage volume from baseline to week 52, measured on MPRAGE sequences by a blinded central imaging core laboratory.

Time frame
Baseline to 52 weeks

Other outcomes

1

Safety and tolerability composite

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.

Time frame
Randomisation to 52 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Middle East North Africa Stroke and Interventional Neurotherapies Organization

Lead sponsor

Alexandria University

Sponsor institution

Source ClinicalTrials.gov

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