Abstract
BackgroundDyslipidemia 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.MethodsA 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.DiscussionThis 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 registrationChinese Clinical Trials Registry ChiCTR1900023515. Registered on 1 June 2019.
Highlights
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)
A recent International Registry of Acute Aortic Dissection (IRAD) study shows that 87–90% of AAD is treated surgically, and drug treatment only accounts for 7–8%
We propose that AAD patients treated with statins will have lower in-hospital mortality than patients without
Summary
Study design This prospective trial was designed as a single-center randomized, open-label, superiority clinical trial with patients allocated 1:1, to be conducted at the First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, China. To obtain 90% power to demonstrate a statistically significant difference (two-sided test, alpha = 0.05) between the two treatments, we anticipate that 307 participants will need to be recruited with154 for the control group and 153 for the statin group. This corresponds to a hazard ratio of 0.4135. The data and safety monitoring committee of the First Affiliated Hospital of Shantou University Medical College will review and interpret the data generated from the study in order to ensure the safety of the participants and the integrity of the research data. Amendment All proposed protocol changes will be recorded in a protocol amendment and this will be submitted to the Committee of Ethics and the regulatory authority for approval
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