NCT05585151招募中4 期
High-Resolution Assessment of Extracranial Plaques in a Multiple Centers Evolocumab Randomized Study
Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年11月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Changes of the thickness of fibrous cap of artery plaque measured by OCT
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Evolocumab treatment group
Experimental
Evolocumab treatment, 1ml：140mg, every 2 weeks, for 26 weeks
干预措施: Evolocumab 140 MG/ML (Drug)
Intensive statin treatment group
Active Comparator
Atorvastatin 40mg/day or rosuvastatin 20mg/day, for 26 weeks
干预措施: Intensive statin treatment (Drug)
结局指标
主要结局
Changes of the thickness of fibrous cap of artery plaque measured by OCT
时间窗: 27 Weeks ± 7 days
Changes of the thickness of fibrous cap of artery plaque measured by OCT
次要结局
- Changes of the calcium aggregation measured by OCT(27 Weeks ± 7 days)
- 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 High resolution magnetic resonance(27 Weeks ± 7 days)
- Changes of arterial plaque volume measured by High resolution magnetic resonance(27 Weeks ± 7 days)
- Changes of the lipid arc of artery plaque measured by OCT(27 Weeks ± 7 days)
- Changes of lipid necrotic core of arterial plaque measured by OCT(27 Weeks ± 7 days)
- Changes of LDL-C levels(27 Weeks ± 7 days)
- 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 High resolution magnetic resonance(27 Weeks ± 7 days)
- Correlation between arterial plaque and new risk factors for cardiovascular and cerebrovascular diseases (serum hsCRP, other markers, etc.)(27 Weeks ± 7 days)
- Changes of arterial plaque volume measured by 3D-ultrasound(27 Weeks ± 7 days)
- Changes of the minimum lumen area (MLA) measured by OCT(27 Weeks ± 7 days)
- Changes of lumen area stenosis measured by OCT(27 Weeks ± 7 days)
- Changes of the number of microvessels measured by OCT(27 Weeks ± 7 days)
- Changes of the presence and extension of macrophages measured by OCT(27 Weeks ± 7 days)
- Changes of arterial plaque volume measured by OCT(27 Weeks ± 7 days)
研究者
Hu Bo
head of Neurology Department
Wuhan Union Hospital, China
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Atherosclerotic Plaque Characteristics Associated With a Progression Rate of the Plaque in Carotids and a Risk of StrokeCarotid Artery PlaqueCarotid WebNCT02360137University Hospital Ostrava1,863
终止
4 期
Reducing Intracranial atheroSclErosis With RepathaIschemic StrokeNCT04573777University of California, Los Angeles10
已完成
3 期
Effect of Evolocumab on Coronary AtherosclerosisCardiovascular DiseaseHyperlipidemiaNCT03689946Cedars-Sinai Medical Center55
进行中（未招募）
2 期
Trial of PCSK9 Inhibition in Patients with Acute Stroke and Symptomatic Intracranial AtherosclerosisIntracranial AtherosclerosisAcute Ischemic StrokeICAS - Intracranial AtherosclerosisNCT05001984Chang Gung Memorial Hospital60
已完成
不适用
New Technologies to Determine Carotid Plaque VulnerabilityCarotid Artery PlaqueAtherosclerosisNCT02224339Mayo Clinic216