PCSK9抑制剂与他汀类药物治疗颅内动脉狭窄(PISTIAS):多中心随机对照试验的原理与设计。

IF 6.3 2区 医学 Q1 CLINICAL NEUROLOGY International Journal of Stroke Pub Date : 2024-10-01 Epub Date: 2024-08-15 DOI:10.1177/17474930241270447
Xinzhi Hu, Zongmuyu Zhang, Caiyan Liu, Mingli Li, Yiyang Liu, Anqi Cheng, Qiuyu Yu, Haoyao Guo, Yinxi Zou, Li Zhou, Hebo Wang, Bo Song, Yong You, Jian Xia, Jingfen Zhang, Zhibing Ai, Qinjian Sun, Ju Han, Jing Liu, Baoquan Lu, Qiwen Deng, Guanzeng Li, Peng-Fei Wang, Xiangqing Li, Yi An, Bo Wu, Zhongrui Yan, Yining Wang, Wei-Hai Xu
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引用次数: 0

摘要

理论依据:Protein convertase subtilisin/kexin type 9 (PCSK9) 抑制剂可使他汀类药物治疗患者的低密度脂蛋白胆固醇(LDL-C)额外降低 54% 至 75%,显示出冠状动脉疾病斑块的消退。然而,使用 PCSK9 抑制剂(如 evolocumabEvolocumab)达到极低水平的 LDL-C 对无症状颅内动脉粥样硬化的影响仍有待探索:目的和假设:确定将 evolocumabEvolocumab 和他汀类药物结合使用是否比单纯他汀类药物治疗能更显著地减少症状性颅内斑块:样本量估计:样本量为1000名受试者,双侧为0.05,20%的受试者失去随访,该研究将有83.3%的力量检测到颅内斑块负担的差异:这是一项由研究者发起的多中心、随机、开放标签、结果评估者盲法试验,旨在评估 EvolocumabEvolocumab 对因颅内动脉狭窄导致的临床急性中风或短暂性脑缺血发作患者基线时和治疗 24 周后通过高分辨率磁共振成像评估的颅内斑块负荷的影响。受试者(n = 1000)将按 1:1 随机分为两组,接受 evolocumabEvolocumab 140 毫克,每两周一次,同时接受他汀类药物治疗或仅接受他汀类药物治疗:主要终点是在基线和24周治疗期结束时通过高分辨率磁共振成像评估斑块负担的变化:该试验将探索他汀类药物和 PCSK9 抑制剂联合治疗是否能实现更显著的斑块消退,提供重要的疗效、机制和安全性数据信息:ChiCTR2300068868;https://www.chictr.org.cn/。
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PCSK9 Inhibitor with Statin Therapy for Intracranial Artery Stenosis ( PISTIAS): Rationale and design of a multicenter randomized controlled trial.

Rationale: Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors enable an additional 54-75% reduction in low-density lipoprotein cholesterol (LDL-C) in statin-treated patients, demonstrating plaque regression in coronary artery disease. However, the impact of achieving an extremely low level of LDL-C with PCSK9 inhibitors (e.g. Evolocumab) on symptomatic intracranial atherosclerosis remains unexplored.

Aim and hypothesis: To determine whether combining Evolocumab and statins achieves a more significant symptomatic intracranial plaque regression than statin therapy alone.

Sample size estimates: With a sample size of 1000 subjects, a two-sided α of 0.05, and 20% lost to follow-up, the study will have 83.3% power to detect the difference in intracranial plaque burden.

Methods and design: This is an investigator-initiated multicenter, randomized, open-label, outcome assessor-blinded trial, evaluating the impact of combining Evolocumab and statins on intracranial plaque burden assessed by high-resolution magnetic resonance imaging at baseline in patients undergoing a clinically indicated acute stroke or transient ischemic attack due to intracranial artery stenosis, and after 24 weeks of treatment. Subjects (n = 1000) were randomized 1:1 into two groups to receive either Evolocumab 140 mg every 2 weeks with statin therapy or statin therapy alone.

Study outcomes: The primary endpoint is the change in intracranial plaque burden assessed by high-resolution magnetic resonance imaging, performed at baseline and at the end of the 24-week treatment period.

Discussion: This trial will explore whether more significant intracranial plaque regression is achievable with the treatment of combining Evolocumab and statins, providing information about efficacy and safety data.

Trial registration number: ChiCTR2300068868; https://www.chictr.org.cn/.

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来源期刊
International Journal of Stroke
International Journal of Stroke 医学-外周血管病
CiteScore
13.90
自引率
6.00%
发文量
132
审稿时长
6-12 weeks
期刊介绍: The International Journal of Stroke is a welcome addition to the international stroke journal landscape in that it concentrates on the clinical aspects of stroke with basic science contributions in areas of clinical interest. Reviews of current topics are broadly based to encompass not only recent advances of global interest but also those which may be more important in certain regions and the journal regularly features items of news interest from all parts of the world. To facilitate the international nature of the journal, our Associate Editors from Europe, Asia, North America and South America coordinate segments of the journal.
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