drugset / Trial / NCT07586540

Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque

NCT07586540

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2027-07
Primary completion
2030-03
Completion
2030-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Alirocumab Monoclonal antibody 150 mg Subcutaneous
Background Atorvastatin Small molecule 80 mg Oral
Background Rosuvastatin Small molecule 40 mg

Indications