High-Resolution Assessment of Extracranial Plaques in a Multiple Centers Evolocumab Randomized Study

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT05585151
Phase
PHASE4
Status
Unknown

Conditions

  • Cerebral Atherosclerosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab 140 MG/ML — DRUG
    Evolocumab 140mg, subcutaneous injection, every 2 weeks, for 26 week, total 13 times
  • Intensive statin treatment — DRUG
    Intensive statin could choose either Atorvastatin 40mg/day or Rosuvastatin 20mg/day, for 26 weeks

Study Details

This study intends to explore the therapeutic effect of PCSK9i Evolocumab on atherosclerotic plaques in cerebral arteries (including carotid and vertebral arteries) compared with intensive statin treatment, and monitor the pathological properties of carotid/vertebral artery plaques with OCT technology. At the same time, three-dimensional ultrasound and high-resolution magnetic resonance are used to explore the new mechanism of pathological changes of cerebral atherosclerotic plaques in a multidimensional manner.

Key Dates

Start date
Nov 9, 2022
Status verified
Dec 2023
Primary completion
Apr 1, 2024
Completion
Oct 1, 2024

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Evolocumab treatment group
    Evolocumab treatment, 1ml：140mg, every 2 weeks, for 26 weeks
  • Active Comparator: Intensive statin treatment group
    Atorvastatin 40mg/day or rosuvastatin 20mg/day, for 26 weeks

Primary Outcome Measure

Changes of the thickness of fibrous cap of artery plaque measured by OCT [ Time Frame: 27 Weeks ± 7 days ]

Central Contacts