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Protocol
Statin treatment for unruptured intracranial aneurysms study: a study protocol for a double-blind, placebo-controlled trial
  1. Wenqiang Li1,
  2. Yisen Zhang1,
  3. Zhongbin Tian1,
  4. Wei Zhu1,
  5. Jian Liu1,
  6. Ying Zhang1,
  7. Xinjian Yang1,
  8. De-Cai Tian2,3,4
  1. 1 Department of Interventional Neuroradiology, Beijing Neurosurgical Institute and Beijing Tiantan Hospital, Capital Medical University, Beijing, China
  2. 2 Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
  3. 3 Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China
  4. 4 China National Clinical Research Center for Neurological Diseases, Beijing, China
  1. Correspondence to Dr De-Cai Tian; decaitian{at}hotmail.com; Dr Xinjian Yang; yangxinjian{at}voiceoftiantan.org

Abstract

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

  • aneurysm
  • inflammation
  • MRI
  • vessel wall
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/.

https://doi.org/10.1136/svn-2020-000353

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    Footnotes

    • WL and YZ are joint first authors.

    • Contributors WL performed the manuscript writing. DT and YisZ made critical revision to the manuscript for important intellectual content. WL, ZT, WZ, JL, YinZ and YisZ participated in the final design of the study. DT and XY conceived and designed the research, and handled funding and supervision. All authors read and approved the final manuscript.

    • Funding This work was supported by National Key Research and Development Plan of China (grant number: 2016YFC1300800), the National Natural Science Foundation of China (grant numbers: 81220108007, 81801156, 81801158, 81471167, 81801199 and 81671139) and the Special Research Project for Capital Health Development (grant number: 2018-4-1077). Beijing Hospitals Authority Youth Programme (code: QML20190503).

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval The study has been approved by the Ethics Committee of Beijing Tiantan Hospital. This clinical trial will be conducted in accordance with the principles laid down by the 18th World Medical Assembly (Declaration of Helsinki, 1964) and all applicable amendments laid down by the World Medical Assemblies and the International Conference on Harmonisation Guidelines for Good Clinical Practice.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available on reasonable request.