Clinical trial NCT05585151: High-Resolution Assessment of Extracranial Plaques in a Multiple Centers Evolocumab Randomized Study
Official title: High-Resolution Assessment of Extracranial Plaques in a Multiple Centers Evolocumab Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cerebral Atherosclerosis
Keywords: atherosclerosis
plaque burden
Evolocumab
High-Resolution assessment
OCT
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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;
3. Participants who understand and sign the informed consent form voluntarily.

Exclusion Criteria:

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

Primary outcomes:
measure: Changes of the thickness of fibrous cap of artery plaque measured by OCT
timeFrame: 27 Weeks ± 7 days
Secondary outcomes:
measure: Changes of the lipid arc of artery plaque measured by OCT
timeFrame: 27 Weeks ± 7 days
measure: Changes of the minimum lumen area (MLA) measured by OCT
timeFrame: 27 Weeks ± 7 days
measure: Changes of lumen area stenosis measured by OCT
timeFrame: 27 Weeks ± 7 days
measure: Changes of the number of microvessels measured by OCT
timeFrame: 27 Weeks ± 7 days
measure: Changes of the presence and extension of macrophages measured by OCT
timeFrame: 27 Weeks ± 7 days
measure: Changes of the calcium aggregation measured by OCT
timeFrame: 27 Weeks ± 7 days
measure: Changes of arterial plaque volume measured by OCT
timeFrame: 27 Weeks ± 7 days
measure: Changes of lipid necrotic core of arterial plaque measured by OCT
timeFrame: 27 Weeks ± 7 days
measure: Changes of LDL-C levels
timeFrame: 27 Weeks ± 7 days
measure: Changes of the thickness of minimum fibrous cap of artery plaque measured by 3D-ultrasound
timeFrame: 27 Weeks ± 7 days
measure: Changes of arterial plaque volume measured by 3D-ultrasound
timeFrame: 27 Weeks ± 7 days
measure: Changes of Lipid necrotic core of arterial plaque measured by 3D-ultrasound
timeFrame: 27 Weeks ± 7 days
measure: Changes of the thickness of minimum fibrous cap of artery plaque measured by High resolution magnetic resonance
timeFrame: 27 Weeks ± 7 days
measure: Changes of arterial plaque volume measured by High resolution magnetic resonance
timeFrame: 27 Weeks ± 7 days
measure: Changes of Lipid necrotic core of arterial plaque measured by High resolution magnetic resonance
timeFrame: 27 Weeks ± 7 days
measure: Correlation between arterial plaque and new risk factors for cardiovascular and cerebrovascular diseases (serum hsCRP, other markers, etc.)
timeFrame: 27 Weeks ± 7 days
Other outcomes:
measure: Occurrence of ischemic vascular events
timeFrame: 27 Weeks ± 7 days
measure: Adverse events/serious adverse events
timeFrame: through study completion, an average of 6 months
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Union Hospital, Tongji Medical College, Huahzong University of Science and Technology
name: Bo Hu, Doctor
role: STUDY_CHAIR
affiliation: Union Hospital, Tongji Medical College, Huahzong University of Science and Technology
name: Candong Hong, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Union Hospital, Tongji Medical College, Huahzong University of Science and Technology
name: Lei Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Union Hospital, Tongji Medical College, Huahzong University of Science and Technology
name: Quanwei He, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Union Hospital, Tongji Medical College, Huahzong University of Science and Technology
name: Jiehong Wu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: