STUDY PROTOCOL article
Front. Neurol.
Sec. Experimental Therapeutics
Volume 16 - 2025 | doi: 10.3389/fneur.2025.1520356
Design of the "EAST" strategy in patients with symptomatic intracranial atherosclerotic stenosis
Provisionally accepted
- 1Department of Neurology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Liaoning Province, China
- 2First Clinical Medical College, Nanjing Medical University, Nanjing, China
- 3Department of Radiology, First Affiliated Hospital, Nanjing Medical University, Nanjing, Jiangsu Province, China
- 4Department of Neurosurgery, First Affiliated Hospital, Nanjing Medical University, Nanjing, Jiangsu Province, China
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Introduction: Intracranial atherosclerotic stenosis (ICAS) is one of the most common causes of stroke worldwide and confers a high risk of stroke recurrence, despite aggressive medical therapy. Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and effectively lowers low-density lipoprotein cholesterol levels. We hypothesize that Evolocumab Added to Statin Therapy (EAST) could stabilize intracranial plaques in patients with symptomatic ICAS.In this prospective, randomized, open-label, blinded end-point study, we will use high-resolution vessel-wall magnetic resonance imaging (HR-vwMRI) to evaluate the efficacy and safety of evolocumab in patients with symptomatic ICAS. Eighty patients with recent stroke/transient ischemic attack (TIA) caused by intracranial artery stenosis will be assigned to the arm of evolocumab plus statin therapy, or the arm of statin therapy in a 1:1 ratio. Patients will undergo HR-vwMRI at recruitment and after 6 months and 12 months. The primary outcome is changes in plaque features evaluated by HR-vwMRI after 6 months' and 12 months' treatment. This trial is being conducted at the first affiliated hospital with Nanjing medical university, China.Written informed consents will be obtained from all participants. Study results will be published as peer-reviewed articles.
Keywords: statin, Intracranial atherosclerotic stenosis, Treatment, HR-vwMRI, PCSK9 inhibitor
Received: 31 Oct 2024; Accepted: 22 Apr 2025.
Copyright: © 2025 Dai, Zhao, Chen, Nie, Gong, Wang, Zhang, Wang and Lu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Zhaolu Wang, Department of Neurology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 201129, Liaoning Province, China
Hua Lu, Department of Neurosurgery, First Affiliated Hospital, Nanjing Medical University, Nanjing, 210029, Jiangsu Province, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.