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Atorvastatin for unruptured intracranial vertebrobasilar dissecting aneurysm (ATREAT-VBD): protocol for a randomised,
Mirzat Turhon1,2, Huibin Kang1,2, Jiliang Huang1,2
1Department of Interventional Neuroradiology, Beijing Neurosurgical Institute, Capital Medical University, Beijing, People's Republic of China.
Insights
This study investigates if atorvastatin can reduce inflammation in vertebrobasilar dissecting aneurysms (VBDAs). Researchers will compare atorvastatin treatment to no treatment in patients with VBDAs to assess changes in aneurysm wall enhancement.
Area of Science:
- Neurology
- Cardiovascular Medicine
- Pharmacology
Background:
- Vertebrobasilar dissecting aneurysms (VBDAs) carry significant risks, with inflammation suspected as a key factor in their progression.
- Atorvastatin, known for its anti-inflammatory properties, presents a potential therapeutic option for managing VBDAs.
Purpose of the Study:
- To evaluate the efficacy of atorvastatin in inhibiting inflammation of the aneurysm wall in patients with VBDAs.
- To assess the impact of atorvastatin on aneurysm wall enhancement, morphology, and inflammatory markers.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 40 patients with non-ruptured VBDAs.
- Participants will receive either 20mg of atorvastatin daily for six months or a placebo.
- Primary outcome is the change in aneurysm wall signal index; secondary outcomes include morphological changes and inflammatory factor levels.
Main Results:
- Data collection is ongoing; results will be published upon study completion.
- The study aims to provide quantitative data on atorvastatin's effect on VBDA inflammation.
Conclusions:
- This research protocol is designed to determine if atorvastatin can serve as a viable treatment to reduce inflammation and potentially improve outcomes for VBDA patients.
- The findings are expected to contribute to evidence-based treatment strategies for vertebrobasilar dissecting aneurysms.
Introduction:
Vertebrobasilar dissecting aneurysms (VBDAs) are associated with serious complications and a poor prognosis. It is believed that inflammation of the aneurysm wall may be the main cause of rupture or deterioration. Atorvastatin has been shown to inhibit inflammation and may be a suitable drug candidate. Here, we report a clinical research study protocol to investigate whether atorvastatin inhibits inflammation of the aneurysm wall, as measured by signal index enhancement.
Methods And Analysis:
We have designed a single-centre, randomised, double-blind, blank-controlled clinical trial. 40 patients with non-ruptured VBDAs with enhancement aneurysm walls will be enrolled in Beijing Tiantan Hospital. Eligible patients will be randomly divided into two treatment groups, at a ratio of 1:1, to receive atorvastatin 20 mg orally for 6 months or no treatment. The primary assessment outcome will be the change in aneurysm wall enhancement, as measured by the signal index during the 6-month treatment period. The secondary assessment outcomes will be the aneurysm morphology (intramural haematoma, dissection valve and false lumen) and changes in the concentrations of inflammatory factors, including C reactive protein, tumour necrosis factor-α, interleukin (IL)-1β and IL-6.
Ethics And Dissemination:
The protocol has been approved by the medical ethics committee of the Beijing Tiantan Hospital at which the work will be conducted (Approval No. KY 2019-024-02). Written informed consent will be obtained from all participants. Findings from the study will be submitted for publication in a peer-reviewed journal.
Trial Registration Number:
NCT04943783.
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