High-Resolution Assessment of Extracranial Plaques in a Multiple Centers Evolocumab Randomized Study
- Conditions
- Cerebral Atherosclerosis
- Interventions
- Drug: Intensive statin treatment
- Registration Number
- NCT05585151
- Lead Sponsor
- Wuhan Union Hospital, China
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Evolocumab treatment group Evolocumab 140 MG/ML Evolocumab treatment, 1ml：140mg, every 2 weeks, for 26 weeks Intensive statin treatment group Intensive statin treatment Atorvastatin 40mg/day or rosuvastatin 20mg/day, for 26 weeks
- Primary Outcome Measures
Name Time Method Changes of the thickness of fibrous cap of artery plaque measured by OCT 27 Weeks ± 7 days Changes of the thickness of fibrous cap of artery plaque measured by OCT
- Secondary Outcome Measures
Name Time Method Changes of the calcium aggregation measured by OCT 27 Weeks ± 7 days Changes of the calcium aggregation measured by OCT
Changes of the thickness of minimum fibrous cap of artery plaque measured by 3D-ultrasound 27 Weeks ± 7 days 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 High resolution magnetic resonance 27 Weeks ± 7 days 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 27 Weeks ± 7 days Changes of arterial plaque volume measured by High resolution magnetic resonance
Changes of the lipid arc of artery plaque measured by OCT 27 Weeks ± 7 days Changes of the lipid arc of artery plaque measured by OCT
Changes of lipid necrotic core of arterial plaque measured by OCT 27 Weeks ± 7 days Changes of lipid necrotic core of arterial plaque measured by OCT
Changes of LDL-C levels 27 Weeks ± 7 days Changes of LDL-C levels
Changes of Lipid necrotic core of arterial plaque measured by 3D-ultrasound 27 Weeks ± 7 days Changes of Lipid necrotic core of arterial plaque measured by 3D-ultrasound
Changes of Lipid necrotic core of arterial plaque measured by High resolution magnetic resonance 27 Weeks ± 7 days 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.) 27 Weeks ± 7 days Correlation between arterial plaque and new risk factors for cardiovascular and cerebrovascular diseases (serum hsCRP, other markers, etc.)
Changes of arterial plaque volume measured by 3D-ultrasound 27 Weeks ± 7 days Changes of arterial plaque volume measured by 3D-ultrasound
Changes of the minimum lumen area (MLA) measured by OCT 27 Weeks ± 7 days Changes of the minimum lumen area (MLA) measured by OCT
Changes of lumen area stenosis measured by OCT 27 Weeks ± 7 days Changes of lumen area stenosis measured by OCT
Changes of the number of microvessels measured by OCT 27 Weeks ± 7 days Changes of the number of microvessels measured by OCT
Changes of the presence and extension of macrophages measured by OCT 27 Weeks ± 7 days Changes of the presence and extension of macrophages measured by OCT
Changes of arterial plaque volume measured by OCT 27 Weeks ± 7 days Changes of arterial plaque volume measured by OCT
Trial Locations
- Locations (1)
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China