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High-Resolution Assessment of Extracranial Plaques

Primary Purpose

Cerebral Atherosclerosis

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Evolocumab 140 MG/ML
Intensive statin treatment
Sponsored by
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Atherosclerosis focused on measuring atherosclerosis, plaque burden, Evolocumab, High-Resolution assessment, OCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 18 years old, regardless of sex;
  2. 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 V1 segment) was 30%-69%; 2) The target vessel for imaging has not undergone or intends to undergo revascularization and must be available for OCT imaging catheter;
  3. Fasting LDL-C level ≥ 1.8mmol/L;
  4. Participants who understand and sign the informed consent form voluntarily.

Exclusion Criteria:

  1. Intolerant to atorvastatin and Rosuvastatin;
  2. A history of major surgery or endovascular therapy within 3 months before the screening period;
  3. Stenosis or occlusion of arteries not caused by atherosclerosis, such as arterial dissection, Moya-moya disease, vasculitis, radio-vascular disease, or fibromuscular dysplasia;
  4. Abnormal liver function (ALT > 3 times the upper limit of normal value);
  5. Abnormal renal function (eGFR < 45 mL/min/1.73m2);
  6. Thrombocytopenia (PLT < 100G/L);
  7. The life expectancy of the subjects is less than 6 months;
  8. During the screening period, there are known serious life-threatening diseases (e.g., hematological disease, malignancy), unstable vital signs or the need for continuous monitoring or a dying state;
  9. Patients have been included in other studies that conflicts with this study;
  10. Known allergy to any product or ingredient during administration;
  11. Pregnant women, breastfeeding, or trying to become pregnant.
  12. Other conditions considered inappropriate for enrollment by the investigators.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Evolocumab treatment group

Intensive statin treatment group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes of the average lipid arc of artery plaque measured by OCT
Changes of the average lipid arc of artery plaque measured by OCT
Changes of the minimum lumen area (MLA) measured by OCT
Changes of the minimum lumen area (MLA) measured by OCT
Changes of lumen area stenosis measured by OCT
Changes of lumen area stenosis measured by OCT
Changes of the number of microvessels measured by OCT
Changes of the number of microvessels measured by OCT
Changes of the presence and extension of macrophages measured by OCT
Changes of the presence and extension of macrophages measured by OCT
Changes of the calcium aggregation measured by OCT
Changes of the calcium aggregation measured by OCT
Changes of arterial plaque volume measured by OCT
Changes of arterial plaque volume measured by OCT
Changes of lipid necrotic core of arterial plaque measured by OCT
Changes of lipid necrotic core of arterial plaque measured by OCT
Changes of LDL-C levels
Changes of LDL-C levels
Changes of the thickness of minimum fibrous cap of artery plaque measured by 3D-ultrasound
Changes of the thickness of minimum fibrous cap of artery plaque measured by 3D-ultrasound
Changes of arterial plaque volume measured by 3D-ultrasound
Changes of arterial plaque volume measured by 3D-ultrasound
Changes of Lipid necrotic core of arterial plaque measured by 3D-ultrasound
Changes of Lipid necrotic core of arterial plaque measured by 3D-ultrasound
Changes of the thickness of minimum fibrous cap of artery plaque measured by High resolution magnetic resonance
Changes of the thickness of minimum fibrous cap of artery plaque measured by High resolution magnetic resonance
Changes of arterial plaque volume measured by High resolution magnetic resonance
Changes of arterial plaque volume measured by High resolution magnetic resonance
Changes of Lipid necrotic core of arterial plaque measured by High resolution magnetic resonance
Changes of Lipid necrotic core of arterial plaque measured by High resolution magnetic resonance
Correlation between arterial plaque and new risk factors for cardiovascular and cerebrovascular diseases (serum hsCRP, other markers, etc.)
Correlation between arterial plaque and new risk factors for cardiovascular and cerebrovascular diseases (serum hsCRP, other markers, etc.)

Full Information

First Posted
October 12, 2022
Last Updated
April 30, 2023
Sponsor
Wuhan Union Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT05585151
Brief Title
High-Resolution Assessment of Extracranial Plaques
Official Title
High-Resolution Assessment of Extracranial Plaques in a Multiple Centers Evolocumab Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan Union Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Atherosclerosis
Keywords
atherosclerosis, plaque burden, Evolocumab, High-Resolution assessment, OCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Evolocumab treatment group
Arm Type
Experimental
Arm Description
Evolocumab treatment, 1ml:140mg, every 2 weeks, for 26 weeks
Arm Title
Intensive statin treatment group
Arm Type
Active Comparator
Arm Description
Atorvastatin 40mg/day or rosuvastatin 20mg/day, for 26 weeks
Intervention Type
Drug
Intervention Name(s)
Evolocumab 140 MG/ML
Intervention Description
Evolocumab 140mg, subcutaneous injection, every 2 weeks, for 26 week, total 13 times
Intervention Type
Drug
Intervention Name(s)
Intensive statin treatment
Intervention Description
Intensive statin could choose either Atorvastatin 40mg/day or Rosuvastatin 20mg/day, for 26 weeks
Primary Outcome Measure Information:
Title
Changes of the thickness of minimum fibrous cap of artery plaque measured by OCT
Description
Changes of the thickness of minimum fibrous cap of artery plaque measured by OCT
Time Frame
27 Weeks ± 7 days
Secondary Outcome Measure Information:
Title
Changes of the average lipid arc of artery plaque measured by OCT
Description
Changes of the average lipid arc of artery plaque measured by OCT
Time Frame
27 Weeks ± 7 days
Title
Changes of the minimum lumen area (MLA) measured by OCT
Description
Changes of the minimum lumen area (MLA) measured by OCT
Time Frame
27 Weeks ± 7 days
Title
Changes of lumen area stenosis measured by OCT
Description
Changes of lumen area stenosis measured by OCT
Time Frame
27 Weeks ± 7 days
Title
Changes of the number of microvessels measured by OCT
Description
Changes of the number of microvessels measured by OCT
Time Frame
27 Weeks ± 7 days
Title
Changes of the presence and extension of macrophages measured by OCT
Description
Changes of the presence and extension of macrophages measured by OCT
Time Frame
27 Weeks ± 7 days
Title
Changes of the calcium aggregation measured by OCT
Description
Changes of the calcium aggregation measured by OCT
Time Frame
27 Weeks ± 7 days
Title
Changes of arterial plaque volume measured by OCT
Description
Changes of arterial plaque volume measured by OCT
Time Frame
27 Weeks ± 7 days
Title
Changes of lipid necrotic core of arterial plaque measured by OCT
Description
Changes of lipid necrotic core of arterial plaque measured by OCT
Time Frame
27 Weeks ± 7 days
Title
Changes of LDL-C levels
Description
Changes of LDL-C levels
Time Frame
27 Weeks ± 7 days
Title
Changes of the thickness of minimum fibrous cap of artery plaque measured by 3D-ultrasound
Description
Changes of the thickness of minimum fibrous cap of artery plaque measured by 3D-ultrasound
Time Frame
27 Weeks ± 7 days
Title
Changes of arterial plaque volume measured by 3D-ultrasound
Description
Changes of arterial plaque volume measured by 3D-ultrasound
Time Frame
27 Weeks ± 7 days
Title
Changes of Lipid necrotic core of arterial plaque measured by 3D-ultrasound
Description
Changes of Lipid necrotic core of arterial plaque measured by 3D-ultrasound
Time Frame
27 Weeks ± 7 days
Title
Changes of the thickness of minimum fibrous cap of artery plaque measured by High resolution magnetic resonance
Description
Changes of the thickness of minimum fibrous cap of artery plaque measured by High resolution magnetic resonance
Time Frame
27 Weeks ± 7 days
Title
Changes of arterial plaque volume measured by High resolution magnetic resonance
Description
Changes of arterial plaque volume measured by High resolution magnetic resonance
Time Frame
27 Weeks ± 7 days
Title
Changes of Lipid necrotic core of arterial plaque measured by High resolution magnetic resonance
Description
Changes of Lipid necrotic core of arterial plaque measured by High resolution magnetic resonance
Time Frame
27 Weeks ± 7 days
Title
Correlation between arterial plaque and new risk factors for cardiovascular and cerebrovascular diseases (serum hsCRP, other markers, etc.)
Description
Correlation between arterial plaque and new risk factors for cardiovascular and cerebrovascular diseases (serum hsCRP, other markers, etc.)
Time Frame
27 Weeks ± 7 days
Other Pre-specified Outcome Measures:
Title
Occurrence of ischemic vascular events
Description
Occurrence of ischemic vascular events, such as TIA, acute cerebral infarction, acute myocardial infarction, etc.
Time Frame
27 Weeks ± 7 days
Title
Adverse events/serious adverse events
Description
Adverse events/serious adverse events
Time Frame
through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Intolerant to atorvastatin and Rosuvastatin; A history of major surgery or endovascular therapy within 3 months before the screening period; Stenosis or occlusion of arteries not caused by atherosclerosis, such as arterial dissection, Moya-moya disease, vasculitis, radio-vascular disease, or fibromuscular dysplasia; Abnormal liver function (ALT > 3 times the upper limit of normal value); Abnormal renal function (eGFR < 45 mL/min/1.73m2); Thrombocytopenia (PLT < 100G/L); The life expectancy of the subjects is less than 6 months; During the screening period, there are known serious life-threatening diseases (e.g., hematological disease, malignancy), unstable vital signs or the need for continuous monitoring or a dying state; Patients have been included in other studies that conflicts with this study; Known allergy to any product or ingredient during administration; Pregnant women, breastfeeding, or trying to become pregnant. Other conditions considered inappropriate for enrollment by the investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Wan, Doctor
Phone
+8615872394527
Email
wanyanalan@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shengcai Chen, Doctor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Hu, Doctor
Organizational Affiliation
Union Hospital, Tongji Medical College, Huahzong University of Science and Technology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Candong Hong, Doctor
Organizational Affiliation
Union Hospital, Tongji Medical College, Huahzong University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lei Zhang, Doctor
Organizational Affiliation
Union Hospital, Tongji Medical College, Huahzong University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Quanwei He, Doctor
Organizational Affiliation
Union Hospital, Tongji Medical College, Huahzong University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiehong Wu, Doctor
Organizational Affiliation
Union Hospital, Tongji Medical College, Huahzong University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Wan, PHD
Phone
+8615872394527
Email
wanyanalan@163.com
First Name & Middle Initial & Last Name & Degree
Shengcai Chen, PHD

12. IPD Sharing Statement

Learn more about this trial

High-Resolution Assessment of Extracranial Plaques

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