Author:
Lv Junchao,Zhao Di,Zhao Gang,Xie Zhen
Abstract
Abstract
Background
As one of the leading causes of morbidity and mortality, stroke and its recurrence has attracted more and more attention. Dl-3-n-butylphthalidle(NBP) has been widely used for treating acute ischemic stroke in China and shows a great clinical effect. NBP plays a role in different pathophysiological processes in the treatment of ischemic stroke, including antioxidants, anti-inflammatory, anti-apoptotic, anti-thrombosis, and mitochondrial protection. Many randomized, double-blind, placebo-controlled, multicenter clinical trials suggest that NBP is a safe and effective treatment for ischemic stroke. To sum up, the current research is mainly focused on the short-term treatment of stroke patients with RCT (randomized controlled trial). Therefore, we designed this study to confirm the role of butylphthalide in secondary stroke prevention in the real world.
Methods
This study will be a multicenter, prospective real-world trial. We would recruit 8000 patients with ischemic stroke from 78 public hospitals in China. All participants will be allocated to one of two parallel treatment groups according to their own wills: (1) butylphthalide group: 0.2 g of butylphthalide capsules three times daily plus routine treatment (aspirin 50-300 mg/d, clopidogrel 75 mg/d, etc.); (2) control group: routine treatment (aspirin 50-300 mg/d, clopidogrel 75 mg/d, etc.). Treatment duration is 90 consecutive days or more. The primary outcome is recurrence rate of stroke within 1 month, 3 months, 6 months and 1 year in butylphthalide group and control group. The secondary outcomes included NIHSS score, the mRS score, other clinical cardiovascular events within one year (sudden death / myocardial infarction / arrhythmia / heart failure, etc.), and adverse events of patients in groups. NIHSS will be captured in the first month after discharge, and the others will be captured at the same time points as the primary end point.
Discussion
This trial will be exploring the efficacy and safety of butylphthalide in secondary prevention of ischemic stroke to expand the scope of application of butylphthalide soft capsules and provide new ideas for enriching the secondary prevention of stroke.
Trial registration
Chinese Clinical Trial Registry (ChiCTR). Trial registration number: ChiCTR2000034481. Registered on 6 July 2020, http://www.chictr.org.cn/showproj.aspx?proj=55800
Funder
Shijiazhuang Pharmaceutical Group Pharmaceutical Co. Ltd.
Xi’an International Medical Center Hospital Hospital Level Project
Natural Science Foundation of Shaanxi Province
Publisher
Springer Science and Business Media LLC
Subject
Neurology (clinical),General Medicine
Reference31 articles.
1. National Health Commission Emergency Medical quality Control Center. Expert consensus on emergency diagnosis and treatment of acute ischemic stroke in China. Chin J Critical Care Med. 2018;38(04):P281-287.
2. Longde W, Jinhuan W, Bin P, et al. Summary of China Stroke Prevention and treatment report 2016. Chin J Cerebrovascular Dis. 2017;14(4):217–24.
3. Benjamin EJ, Muntner P, Alonso A. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019;139(10):e56-e28.
4. Chen XQ, Qiu K, Liu H, Lu W. Application and prospects of butylphthalide for the treatment of neurologic diseases. Chin Med J (Engl). 2019;132(12):1467–77.
5. Cerebral blood flow and metabolism Branch of Chinese Stroke Society. Chinese Guidelines for collateral circulation assessment and intervention in ischemic stroke (2017). Chin J Internal Med. 2017;56(06):460–71.
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