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

NCT05585151 | Unknown Phase 4

• 1 other identifier: HERALD
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

atherosclerosis; plaque burden; Evolocumab; High-Resolution assessment; OCT

Outcome Measures

Primary Outcomes (1)

• Changes of the thickness of fibrous cap of artery plaque measured by OCT

  Changes of the thickness of fibrous cap of artery plaque measured by OCT

  27 Weeks ± 7 days

Secondary Outcomes (16)

• Changes of the lipid arc of artery plaque measured by OCT

  27 Weeks ± 7 days

• Changes of the minimum lumen area (MLA) measured by OCT

  27 Weeks ± 7 days

• Changes of lumen area stenosis measured by OCT

  27 Weeks ± 7 days

• Changes of the number of microvessels measured by OCT

  27 Weeks ± 7 days

• Changes of the presence and extension of macrophages measured by OCT

  27 Weeks ± 7 days

Other Outcomes (2)

• Occurrence of ischemic vascular events

  27 Weeks ± 7 days

• Adverse events/serious adverse events

  through study completion, an average of 6 months

Study Arms (2)

Evolocumab treatment group

EXPERIMENTAL

Evolocumab treatment, 1ml：140mg, every 2 weeks, for 26 weeks

Drug: Evolocumab 140 MG/ML

Intensive statin treatment group

ACTIVE COMPARATOR

Atorvastatin 40mg/day or rosuvastatin 20mg/day, for 26 weeks

Drug: Intensive statin treatment

Interventions

Evolocumab 140 MG/ML DRUG

Evolocumab 140mg, subcutaneous injection, every 2 weeks, for 26 week, total 13 times

Evolocumab treatment group

Intensive statin treatment DRUG

Intensive statin could choose either Atorvastatin 40mg/day or Rosuvastatin 20mg/day, for 26 weeks

Intensive statin treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, regardless of sex;
• Cerebrovascular angiography examination was performed, and the imaging characteristics were consistent with: 1) The stenosis degree of internal carotid artery (starting from C1 segment) or vertebral artery (starting from vertebral artery to V4 segment) was 20%-69%; 2) The target vessel for imaging has not undergone or intends to undergo revascularization and must be available for OCT imaging catheter;
• Participants who understand and sign the informed consent form voluntarily.

You may not qualify if:

• Intolerant to both atorvastatin and rosuvastatin;
• History of major surgery or endovascular treatment within 3 months prior to the screening period;
• Arterial stenosis or occlusion not caused by atherosclerosis, such as arterial dissection, moya-moya disease, vasculitis, radiation vascular disease, or fibromuscular dysplasia;
• Abnormal liver function (ALT \> 3 times the upper limit of normal);
• Renal dysfunction (glomerular filtration rate (eGFR) \<45 mL/min/1.73m2 at screening);
• Thrombocytopenia (PLT\<100G/L);
• The expected survival time is not more than 6 months;
• Other known serious life-threatening disease (such as hematologic disease, malignancy), unstable vital signs or need for continuous monitoring, or moribund state during screening;
• Patients have been included in other studies that conflict with this study;
• Known sensitivity to any of the products or components to be administered during dosing;
• Pregnant, breastfeeding or planning pregnancy, and other conditions that the investigator considers the patient unsuitable for enrollment;
• Other conditions that the investigator considered inappropriate for enrollment.

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Intracranial Arteriosclerosis; Atherosclerosis

Interventions

evolocumab

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bo Hu, Doctor

  Union Hospital, Tongji Medical College, Huahzong University of Science and Technology

  STUDY CHAIR

• Candong Hong, Doctor

  Union Hospital, Tongji Medical College, Huahzong University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Lei Zhang, Doctor

  Union Hospital, Tongji Medical College, Huahzong University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Quanwei He, Doctor

  Union Hospital, Tongji Medical College, Huahzong University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Jiehong Wu, Doctor

  Union Hospital, Tongji Medical College, Huahzong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Wan, Doctor

CONTACT

+8615872394527; wanyanalan@163.com

Shengcai Chen, Doctor

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of Neurology Department

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 18, 2022
• Study Start: November 9, 2022
• Primary Completion: April 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

CN (1)