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

NCT05585151 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-12-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Bo Hu, Doctor · Union Hospital, Tongji Medical College, Huahzong University of Science and Technology

  • Candong Hong, Doctor · Union Hospital, Tongji Medical College, Huahzong University of Science and Technology

  • Lei Zhang, Doctor · Union Hospital, Tongji Medical College, Huahzong University of Science and Technology

  • Quanwei He, Doctor · Union Hospital, Tongji Medical College, Huahzong University of Science and Technology

  • Jiehong Wu, Doctor · Union Hospital, Tongji Medical College, Huahzong University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-09
Primary Completion
2024-04-01
Completion
2024-10-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05585151 on ClinicalTrials.gov