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

Launched by WUHAN UNION HOSPITAL, CHINA · Oct 15, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how well a medication called Evolocumab works in treating a specific condition called cerebral atherosclerosis, which affects the arteries in the brain. The study will compare Evolocumab to a common cholesterol-lowering treatment called statins. Researchers will use advanced imaging techniques to closely examine the plaque in the arteries to understand how the treatment affects these plaques.

To participate, you need to be at least 18 years old and have some narrowing in your carotid or vertebral arteries, as shown by an imaging test. You should not have had any major surgeries recently or have certain serious health conditions. If you join the trial, you will receive either Evolocumab or statin treatment and have regular check-ups to monitor your health and the state of your arteries. This study is currently recruiting participants, and it aims to help improve treatments for people with this condition.

Gender

ALL

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.