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Statin treatment for unruptured intracranial aneurysms study: a study protocol for a double-blind, placebo-controlled trial

BACKGROUND AND PURPOSE: A large proportion of patients with unruptured intracranial aneurysm (IA) are not suitable for surgical clipping and endovascular treatment. For these patients, anti-inflammatory medications are worth exploring due to inflammation of aneurysmal wall being a major factor in hi...

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Autores principales: Li, Wenqiang, Zhang, Yisen, Tian, Zhongbin, Zhu, Wei, Liu, Jian, Zhang, Ying, Yang, Xinjian, Tian, De-Cai
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7804054/
https://www.ncbi.nlm.nih.gov/pubmed/32381630
http://dx.doi.org/10.1136/svn-2020-000353
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author Li, Wenqiang
Zhang, Yisen
Tian, Zhongbin
Zhu, Wei
Liu, Jian
Zhang, Ying
Yang, Xinjian
Tian, De-Cai
author_facet Li, Wenqiang
Zhang, Yisen
Tian, Zhongbin
Zhu, Wei
Liu, Jian
Zhang, Ying
Yang, Xinjian
Tian, De-Cai
author_sort Li, Wenqiang
collection PubMed
description BACKGROUND AND PURPOSE: A large proportion of patients with unruptured intracranial aneurysm (IA) are not suitable for surgical clipping and endovascular treatment. For these patients, anti-inflammatory medications are worth exploring due to inflammation of aneurysmal wall being a major factor in higher risk of rupture. Statin has been proven to reduce inflammation of atherosclerosis and maybe a suitable candidate. This study aimed to evaluate whether atorvastatin will reduce inflammatory of the aneurysm wall measured by the signal index of aneurysm wall enhancement. METHODS AND ANALYSIS: The Statin Treatment for UnruptureD Intracranial anEurysms Study is a single-centre, phase 2, randomised, controlled, double-blind clinical trial. 60 patients with unruptured IAs with aneurysm wall enhancement will be enrolled in Beijing Tiantan Hospital. The patients will be randomised to receive atorvastatin 20 mg or placebo orally per day for 12 months. The primary outcome will be the change in aneurysm wall enhancement measured by the signal index during the 12 months treatment with atorvastatin. The secondary study outcomes will be the change in aneurysm wall enhancement measured by the signal index at 3 months, the changes in aneurysmal morphology and inflammation-related factors (C reactive protein, tumour necrosis factor-α, interleukin-1β and interleukin-6) at 3 and 12 months. This study is the first to explore the role of atorvastatin in reducing inflammation in unruptured IA, which could lay the groundwork for future phase III trial. ETHICS AND DISSEMINATION: Beijing Tiantan Hospital’s Ethics committee approved the research and written informed consents would be obtained from all participant or representative included in this study. TRIAL REGISTRATION NUMBER: NCT04149483
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spelling pubmed-78040542021-01-19 Statin treatment for unruptured intracranial aneurysms study: a study protocol for a double-blind, placebo-controlled trial Li, Wenqiang Zhang, Yisen Tian, Zhongbin Zhu, Wei Liu, Jian Zhang, Ying Yang, Xinjian Tian, De-Cai Stroke Vasc Neurol Protocol BACKGROUND AND PURPOSE: A large proportion of patients with unruptured intracranial aneurysm (IA) are not suitable for surgical clipping and endovascular treatment. For these patients, anti-inflammatory medications are worth exploring due to inflammation of aneurysmal wall being a major factor in higher risk of rupture. Statin has been proven to reduce inflammation of atherosclerosis and maybe a suitable candidate. This study aimed to evaluate whether atorvastatin will reduce inflammatory of the aneurysm wall measured by the signal index of aneurysm wall enhancement. METHODS AND ANALYSIS: The Statin Treatment for UnruptureD Intracranial anEurysms Study is a single-centre, phase 2, randomised, controlled, double-blind clinical trial. 60 patients with unruptured IAs with aneurysm wall enhancement will be enrolled in Beijing Tiantan Hospital. The patients will be randomised to receive atorvastatin 20 mg or placebo orally per day for 12 months. The primary outcome will be the change in aneurysm wall enhancement measured by the signal index during the 12 months treatment with atorvastatin. The secondary study outcomes will be the change in aneurysm wall enhancement measured by the signal index at 3 months, the changes in aneurysmal morphology and inflammation-related factors (C reactive protein, tumour necrosis factor-α, interleukin-1β and interleukin-6) at 3 and 12 months. This study is the first to explore the role of atorvastatin in reducing inflammation in unruptured IA, which could lay the groundwork for future phase III trial. ETHICS AND DISSEMINATION: Beijing Tiantan Hospital’s Ethics committee approved the research and written informed consents would be obtained from all participant or representative included in this study. TRIAL REGISTRATION NUMBER: NCT04149483 BMJ Publishing Group 2020-05-06 /pmc/articles/PMC7804054/ /pubmed/32381630 http://dx.doi.org/10.1136/svn-2020-000353 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Protocol
Li, Wenqiang
Zhang, Yisen
Tian, Zhongbin
Zhu, Wei
Liu, Jian
Zhang, Ying
Yang, Xinjian
Tian, De-Cai
Statin treatment for unruptured intracranial aneurysms study: a study protocol for a double-blind, placebo-controlled trial
title Statin treatment for unruptured intracranial aneurysms study: a study protocol for a double-blind, placebo-controlled trial
title_full Statin treatment for unruptured intracranial aneurysms study: a study protocol for a double-blind, placebo-controlled trial
title_fullStr Statin treatment for unruptured intracranial aneurysms study: a study protocol for a double-blind, placebo-controlled trial
title_full_unstemmed Statin treatment for unruptured intracranial aneurysms study: a study protocol for a double-blind, placebo-controlled trial
title_short Statin treatment for unruptured intracranial aneurysms study: a study protocol for a double-blind, placebo-controlled trial
title_sort statin treatment for unruptured intracranial aneurysms study: a study protocol for a double-blind, placebo-controlled trial
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7804054/
https://www.ncbi.nlm.nih.gov/pubmed/32381630
http://dx.doi.org/10.1136/svn-2020-000353
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