Effect of Evolocumab on Carotid Plaque Composition in Asymptomatic Carotid Artery Stenosis (EVOCAR-1)
- Sponsor
- Imperial College Healthcare NHS Trust
- Study ID
- NCT03931161
- Phase
- PHASE4
- Status
- Unknown
Conditions
- Carotid Artery Stenosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Evolocumab Auto-Injector [Repatha] — DRUGAuto-Injector, 140 mg every two weeks.
- Placebo Auto-Injector — DRUGMatching Placebo for the active comparator (Evolocumab)
Study Details
This is a phase IV, randomised, placebo-controlled, double-blind, parallel group study to determine the effect of Evolocumab treatment on carotid plaque morphology and composition in asymptomatic patients with \>50% carotid artery stenosis.
Key Dates
- Start date
- Sep 4, 2019
- Status verified
- Oct 2022
- Primary completion
- May 6, 2023
- Completion
- May 6, 2024
Study Design
- Enrollment
- 33 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: PlaceboMatching Placebo.
- Active Comparator: EvolocumabEvolocumab Auto-Injector \[Repatha\]
Primary Outcome Measure
Change in lipid-rich necrotic core [ Time Frame: 12 months ]