Evaluating Evolocumab for treating atherosclerotic plaques in cerebral arteries

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

This study is testing if the medication Evolocumab can help reduce harmful plaques in the brain's arteries better than standard cholesterol-lowering drugs.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Wuhan Union Hospital, China (other)
• Drugs / interventions: radiation, Evolocumab
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT05585151 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of the PCSK9 inhibitor Evolocumab on atherosclerotic plaques in the cerebral arteries, comparing its efficacy to intensive statin treatment. It employs advanced imaging techniques, including optical coherence tomography (OCT), three-dimensional ultrasound, and high-resolution magnetic resonance imaging, to assess the pathological properties of plaques in the carotid and vertebral arteries. The goal is to understand the mechanisms of plaque changes in a comprehensive manner.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a specific degree of stenosis in their carotid or vertebral arteries and who have not undergone revascularization.

Not a fit: Patients who are intolerant to statins or have conditions unrelated to atherosclerosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with cerebral atherosclerosis, potentially reducing the risk of stroke.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in evaluating the effects of PCSK9 inhibitors on atherosclerosis, suggesting potential for success.

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.

Where this trial is running

Wuhan, Hubei

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Principal investigator: Candong Hong, Doctor — Union Hospital, Tongji Medical College, Huahzong University of Science and Technology
• Study coordinator: Yan Wan, Doctor

Conditions: Cerebral Atherosclerosis, atherosclerosis, plaque burden, Evolocumab, High-Resolution assessment, OCT