High-Resolution Assessment of Extracranial Plaques in Evolocumab Treatment

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Treatments: Evolocumab

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 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.