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

Efficiency of atorvastatin on in-hospital mortality of patients with acute aortic dissection (AAD): study protocol for a randomized, open-label, superiority clinical trial.
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DOI:
10.1186/s13063-021-05237-1
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发表时间:
2021-04-14
期刊:
影响因子:
2.5
通讯作者:
Tan X
Tan X
中科院分区:
医学4区
文献类型:
--
作者:
Chen Y;Xiong N;Wang X;Wu S;Hong L;Huang X;Chen C;Li W;Wang B;Ye S;Tan X

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血脂异常和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,提示他汀类药物可能在预防和治疗AAD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患者生存的影响很少被研究,特别是在随机试验中。在这项研究中,我们将进行一项随机临床试验,以了解他汀类药物是否可以降低AAD患者的住院死亡率。招募汕头大学医学院第一附属医院确诊为AAD的384名受试者。参与者将被随机分为阿托伐他汀治疗组和对照组。主要结局是30天的住院死亡率。本研究旨在验证阿托伐他汀降低AAD患者住院死亡率的有效性。目的是提供一种新的方法来提高生存率,作为传统药物治疗的补充。中国临床试验注册中心ChiCTR1900023515。2019年6月1日注册。
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. 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. 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. Chinese Clinical Trials Registry ChiCTR1900023515. Registered on 1 June 2019.
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