drugset / Trial / NCT07586540
Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque
Phase 3
Not yet recruiting
280 enrolled
Middle East North Africa Stroke and Interventional Neurotherapies Organization
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alirocumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Background | Atorvastatin | Small molecule | 80 mg | Oral |
| Background | Rosuvastatin | Small molecule | 40 mg | — |