Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 5, 2023
Open Peer Review Period: Sep 4, 2023 - Oct 30, 2023
Date Accepted: Nov 23, 2023
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Clinical Effectiveness and Safety of Dazhu Hongjingtian Injection in Ischemic Stroke: Protocol for a Prospective, Multicenter, Observational Study
ABSTRACT
Background:
Previous studies have reported the positive effects of Dazhu hongjingtian injection (DZHJTI) on acute ischemic strokes (AIS), however, these findings require further validation in routine clinical practice. Therefore, the aim of this study is to assess the effectiveness and safety of DZHJTI therapy for AIS in real-world settings.
Objective:
The aim of this study is to evaluate the effectiveness and safety of DZHJTI treatment for AIS in real-world clinical settings.
Methods:
This prospective, multicenter cohort study plans to enroll 2000 AIS patients within 14 days of symptom onset from 30 hospitals across China. Eligible patients will be followed up for 6 months after initiating medication treatments. The primary outcome will be the change in the National Institute of Health Stroke Scale score from baseline to outpatient. The secondary outcomes include overall mortality, stroke recurrence, new-onset major vascular events, global disability, and improvement of traditional Chinese medicine syndrome in 6 months. Adverse events or clinically significant changes in vital signs and laboratory parameters, regardless of the severity, will be recorded during the trial to assess the safety of DZHJTI. An augmented inverse propensity weighted estimator will be used to reduce variability and improve accuracy in average treatment effects estimation.
Results:
In October 2022, the clinical trial registration was approved. Future outcomes will be published in professional peer-reviewed health-related research journals in 2025.
Conclusions:
This real-world cohort study is the first to assess the effectiveness and safety of DZHJTI in patients with AIS. It may provide additional clinical evidence, including the duration of response, long-term drug effectiveness, and subgroup efficacy data. The study results will be valuable for clinicians and patients seeking optimal treatment for AIS, and could lead to better clinical decision-making and improved patient outcomes. Clinical Trial: itmctr.ccebtcm.org.cn, identifier ITMCTR2022000005. Registered on October 8, 2022.
Citation
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Copyright
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