NCT05585151

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cerebral Atherosclerosis

Interventions

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

Timeline

• Start date: 2022-11-09
• Primary completion: 2024-04-01
• Completion: 2024-10-01
• First posted: 2022-10-18
• Last updated: 2023-12-11

Locations

1 site across 1 country: China