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

Cerebral Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05585151
• Other study ID #: HERALD
• Status: Recruiting
• Phase: Phase 4
• Start date: November 9, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: December 2023
• Source: Wuhan Union Hospital, China
• Contact: Yan Wan, Doctor
• Phone: +8615872394527
• Email: wanyanalan[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Cerebral Atherosclerosis
• Intracranial Arteriosclerosis

Intervention

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

Locations

Country	Name	City	State
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Occurrence of ischemic vascular events	Occurrence of ischemic vascular events, such as TIA, acute cerebral infarction, acute myocardial infarction, etc.	27 Weeks ± 7 days
Other	Adverse events/serious adverse events	Adverse events/serious adverse events	through study completion, an average of 6 months
Primary	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	Changes of the lipid arc of artery plaque measured by OCT	Changes of the lipid arc of artery plaque measured by OCT	27 Weeks ± 7 days
Secondary	Changes of the minimum lumen area (MLA) measured by OCT	Changes of the minimum lumen area (MLA) measured by OCT	27 Weeks ± 7 days
Secondary	Changes of lumen area stenosis measured by OCT	Changes of lumen area stenosis measured by OCT	27 Weeks ± 7 days
Secondary	Changes of the number of microvessels measured by OCT	Changes of the number of microvessels measured by OCT	27 Weeks ± 7 days
Secondary	Changes of the presence and extension of macrophages measured by OCT	Changes of the presence and extension of macrophages measured by OCT	27 Weeks ± 7 days
Secondary	Changes of the calcium aggregation measured by OCT	Changes of the calcium aggregation measured by OCT	27 Weeks ± 7 days
Secondary	Changes of arterial plaque volume measured by OCT	Changes of arterial plaque volume measured by OCT	27 Weeks ± 7 days
Secondary	Changes of lipid necrotic core of arterial plaque measured by OCT	Changes of lipid necrotic core of arterial plaque measured by OCT	27 Weeks ± 7 days
Secondary	Changes of LDL-C levels	Changes of LDL-C levels	27 Weeks ± 7 days
Secondary	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	27 Weeks ± 7 days
Secondary	Changes of arterial plaque volume measured by 3D-ultrasound	Changes of arterial plaque volume measured by 3D-ultrasound	27 Weeks ± 7 days
Secondary	Changes of Lipid necrotic core of arterial plaque measured by 3D-ultrasound	Changes of Lipid necrotic core of arterial plaque measured by 3D-ultrasound	27 Weeks ± 7 days
Secondary	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	27 Weeks ± 7 days
Secondary	Changes of arterial plaque volume measured by High resolution magnetic resonance	Changes of arterial plaque volume measured by High resolution magnetic resonance	27 Weeks ± 7 days
Secondary	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	27 Weeks ± 7 days
Secondary	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.)	27 Weeks ± 7 days