UnknownPhase 4

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

China200 participantsStarted 2022-11-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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;

What they're measuring

Changes of the thickness of fibrous cap of artery plaque measured by OCT

Timeframe: 27 Weeks ± 7 days

Trial details

NCT IDNCT05585151

SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-01

Contact for this trial

Yan Wan, Doctor

+8615872394527 wanyanalan@163.com

View on ClinicalTrials.gov More Cerebral Atherosclerosis trials