Efficiency of atorvastatin on in-hospital mortality of patients with acute aortic dissection (AAD): study protocol for a randomized, open-label, superiority clinical trial
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 prevention and treatment of AAD. Some retrospective studies show that statins can protect patients with aortic dissection. However, the effect of statins on 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.
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: Registered by the Chinese Clinical Trials Registry (Registration number: ChiCTR1900023515, http://www.chictr.org.cn/edit.aspx?pid=38275&htm=4). Registered 1 June 2019.
Figure 1
Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
Posted 13 Jan, 2021
Received 13 Jan, 2021
On 03 Jan, 2021
On 03 Jan, 2021
On 30 Dec, 2020
Invitations sent on 30 Dec, 2020
On 30 Dec, 2020
On 29 Nov, 2020
Received 26 Nov, 2020
On 23 Nov, 2020
Received 22 Nov, 2020
Received 03 Nov, 2020
On 01 Nov, 2020
On 01 Nov, 2020
Invitations sent on 31 Oct, 2020
On 12 Aug, 2020
On 25 Jul, 2020
On 27 May, 2020
Efficiency of atorvastatin on in-hospital mortality of patients with acute aortic dissection (AAD): study protocol for a randomized, open-label, superiority clinical trial
Posted 13 Jan, 2021
Received 13 Jan, 2021
On 03 Jan, 2021
On 03 Jan, 2021
On 30 Dec, 2020
Invitations sent on 30 Dec, 2020
On 30 Dec, 2020
On 29 Nov, 2020
Received 26 Nov, 2020
On 23 Nov, 2020
Received 22 Nov, 2020
Received 03 Nov, 2020
On 01 Nov, 2020
On 01 Nov, 2020
Invitations sent on 31 Oct, 2020
On 12 Aug, 2020
On 25 Jul, 2020
On 27 May, 2020
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 prevention and treatment of AAD. Some retrospective studies show that statins can protect patients with aortic dissection. However, the effect of statins on 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.
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: Registered by the Chinese Clinical Trials Registry (Registration number: ChiCTR1900023515, http://www.chictr.org.cn/edit.aspx?pid=38275&htm=4). Registered 1 June 2019.
Figure 1
Figure 2