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阿托伐他汀对急性主动脉夹层(AAD)患者院内死亡率的影响:一项随机、开放标签、优效性临床试验的研究方案

Efficiency of atorvastatin on in-hospital mortality of patients with acute aortic dissection (AAD): study protocol for a randomized, open-label, superiority clinical trial.

作者信息

Chen Yequn, Xiong Nianling, Wang Xin, Wu Shiwan, Hong Liangli, Huang Xiru, Chen Chang, Li Weiping, Wang Bin, Ye Shu, Tan Xuerui

机构信息

The First Affiliated Hospital of Shantou University Medical College, Shantou, 515041, Guangdong, China.

Clinical Research Center, The First Affiliated Hospital of Shantou University Medical College (SUMC), Shantou, China.

出版信息

Trials. 2021 Apr 14;22(1):281. doi: 10.1186/s13063-021-05237-1.

DOI:10.1186/s13063-021-05237-1
PMID:33853639
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8048168/
Abstract

BACKGROUND

Dyslipidemia and local inflammation at sites of lipid deposition on blood vessel walls have been demonstrated to be risk factors for patients with acute aortic dissection (AAD). Statins have anti-inflammatory and lipid-lowering effects, which suggest that statins may play an important role in the prevention and treatment of AAD. Some retrospective studies show that statins can protect patients with aortic dissection. However, the effect of statins on the survival of AAD patients has been scarcely investigated, especially in randomized trials. In this study, we will perform a randomized clinical trial to understand whether statins can reduce in-hospital mortality of AAD patients.

METHODS

A total of 384 subjects diagnosed with AAD in the First Affiliated Hospital of Shantou University Medical College will be recruited. Participants will be randomly divided into an atorvastatin-treated or control group. The primary outcome will be the in-hospital mortality at 30 days.

DISCUSSION

This study is designed to verify the efficacy of atorvastatin on reducing in-hospital mortality of patients with AAD. The aim is to provide a new means of improving survival as a complement to conventional drug therapy.

TRIAL REGISTRATION

Chinese Clinical Trials Registry ChiCTR1900023515 . Registered on 1 June 2019.

摘要

背景

血脂异常以及血管壁脂质沉积部位的局部炎症已被证明是急性主动脉夹层(AAD)患者的危险因素。他汀类药物具有抗炎和降脂作用,这表明他汀类药物可能在AAD的预防和治疗中发挥重要作用。一些回顾性研究表明,他汀类药物可以保护主动脉夹层患者。然而,他汀类药物对AAD患者生存率的影响鲜有研究,尤其是在随机试验中。在本研究中,我们将进行一项随机临床试验,以了解他汀类药物是否能降低AAD患者的院内死亡率。

方法

将招募汕头大学医学院第一附属医院384例诊断为AAD的受试者。参与者将被随机分为阿托伐他汀治疗组或对照组。主要结局将是30天时的院内死亡率。

讨论

本研究旨在验证阿托伐他汀降低AAD患者院内死亡率的疗效。目的是提供一种改善生存率的新方法,作为传统药物治疗的补充。

试验注册

中国临床试验注册中心ChiCTR1900023515。于2019年6月1日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f93a/8048168/cd1dce70b26f/13063_2021_5237_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f93a/8048168/8dcf07bae95f/13063_2021_5237_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f93a/8048168/cd1dce70b26f/13063_2021_5237_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f93a/8048168/8dcf07bae95f/13063_2021_5237_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f93a/8048168/cd1dce70b26f/13063_2021_5237_Fig2_HTML.jpg

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