Xingnaojing for Moderate-to-severe Acute ischemic Stroke (XMAS): study protocol for a randomized controlled trial

Xinxing Lai, Kegang Cao, Lingbo Kong, Qiang Liu, Ying Gao, XMAS study investigators, Xinxing Lai, Kegang Cao, Lingbo Kong, Qiang Liu, Ying Gao, XMAS study investigators

Abstract

Background: Xingnaojing injection (XNJ) is widely used for the treatment of stroke in China. However, there is currently a lack of high-quality evidence of its efficacy for acute ischemic stroke. The main objective of this study is to determine whether the addition of XNJ to standard care improves the 3-month functional outcome in patients with acute ischemic stroke (AIS).

Methods/design: The XMAS study is a multicenter, prospective, randomized controlled, open-label trial with a blinded endpoints design. A total of 720 patients will be randomly allocated to either the intervention or the control group in a 1:1 ratio. The intervention group receives XNJ combined with standard care, and the control group receives standard care alone. XNJ will be administered intravenously every 12 h for 10 days. The primary outcome is the proportion of patients who are independent at 3 months after stroke onset defined as a modified Rankin Scale score of 0 to 2. Secondary outcomes include early neurological deterioration at 48 h, the change in National Institutes of Health Stroke Scale score, patient-reported outcome, symptomatic intracranial hemorrhage at 10 days, the Barthel Index score, deaths from any cause and cardiovascular events at 3 months.

Discussion: The results of this trial will provide critical evidence for XNJ in the treatment of AIS as a complementary approach that can be initiated after reperfusion therapy or when the AIS is not eligible for thrombolytic treatment.

Trial registration: Clinical Trials.gov, ID: NCT02728180 . Registered on 28 March 2016.

Keywords: Acute ischemic stroke; Chinese medicine; Randomized controlled trial; Xingnaojing injection.

Conflict of interest statement

Ethics approval and consent to participate

The XMAS trial will be conducted according to the principles of the Declaration of Helsinki, as amended by the World Medical Association General Assembly in October 2013. Trial organization, data management, monitoring and reporting of the study will also be performed in accordance with the guidelines for Good Clinical Practice and other regulations. Patients will be given full and adequate oral and written information about the nature and purpose of the study, potential benefits and risks before allocation. The consent provider will be the patient if they are competent, or a legally authorized representative if the patient is not competent. This trial has been approved by the Institutional Review Board (IRB) of Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (Approval number. ECPJ-BDY-2015-02-01) as well as the local IRB of each site if required before the start of recruitment.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow diagram of the Xingnaojing for Moderate-to-severe Acute ischemic Stroke (XMAS) study

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