Evaluating Evolocumab for treating atherosclerotic plaques in cerebral arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: wanyanalan@163.com
• Phone: +8615872394527

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Intelligent lipid-management system to help stroke or TIA patients on evolocumab reach one-year LDL-C targets

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• Evaluating the effects of obicetrapib and evolocumab on Lp(a) levels

  This study is testing if a new medication called obicetrapib, alone and with another drug called evolocumab, can lower Lp(a) levels in people who have high Lp(a).

  Recruiting Phase 2 NewAmsterdam Pharma · Philadelphia, Pennsylvania · NCT06496243

• Intensive statin therapy for ischemic stroke with intracranial atherosclerotic plaques

  This study is testing whether stronger doses of statin medication can help people who have had an ischemic stroke due to plaque buildup in their brain arteries.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.