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Study protocol
Efficiency of atorvastatin on in-hospital mortality of patients with acute aortic dissection (AAD): study protocol for a randomized, open-label, superiority clinical trial
Nianling Xiong
First Hospital of Medical College of Shantou University
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1304-7743
License:
This work is licensed under a CC BY 4.0 License. Read Full License
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.
Keywords
Acute aortic dissection, atorvastatin, statins, in-hospital mortality
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CURRENT STATUS: Under Review
Version 2
Posted 13 Jan, 2021
No community comments so far
Review #1 received
Received 13 Jan, 2021
Reviewer #2 agreed
On 03 Jan, 2021
Reviewer #1 agreed
On 03 Jan, 2021
Editor assigned
On 30 Dec, 2020
Reviewers invited
Invitations sent on 30 Dec, 2020
Submission checks complete
On 30 Dec, 2020
No comments provided
Editorial decision: Major revision
On 29 Nov, 2020
Review #3 received
Received 26 Nov, 2020
Reviewer #3 agreed
On 23 Nov, 2020
Review #2 received
Received 22 Nov, 2020
Review #1 received
Received 03 Nov, 2020
Reviewer #2 agreed
On 01 Nov, 2020
Reviewer #1 agreed
On 01 Nov, 2020
Reviewers invited
Invitations sent on 31 Oct, 2020
Editor assigned
On 12 Aug, 2020
Submission checks complete
On 25 Jul, 2020
First submitted
On 27 May, 2020
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Efficiency of atorvastatin on in-hospital mortality of patients with acute aortic dissection (AAD): study protocol for a randomized, open-label, superiority clinical trial
Nianling Xiong
First Hospital of Medical College of Shantou University
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1304-7743
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 2
Posted 13 Jan, 2021
No community comments so far
Review #1 received
Received 13 Jan, 2021
Reviewer #2 agreed
On 03 Jan, 2021
Reviewer #1 agreed
On 03 Jan, 2021
Editor assigned
On 30 Dec, 2020
Reviewers invited
Invitations sent on 30 Dec, 2020
Submission checks complete
On 30 Dec, 2020
No comments provided
Editorial decision: Major revision
On 29 Nov, 2020
Review #3 received
Received 26 Nov, 2020
Reviewer #3 agreed
On 23 Nov, 2020
Review #2 received
Received 22 Nov, 2020
Review #1 received
Received 03 Nov, 2020
Reviewer #2 agreed
On 01 Nov, 2020
Reviewer #1 agreed
On 01 Nov, 2020
Reviewers invited
Invitations sent on 31 Oct, 2020
Editor assigned
On 12 Aug, 2020
Submission checks complete
On 25 Jul, 2020
First submitted
On 27 May, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
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