Dazhu Hongjingtian Injection for Ischemic Stroke: Protocol for a Prospective, Multicenter Observational Study

Area of Science:

• Neurology
• Clinical Pharmacology
• Real-World Evidence Studies

Background:

• Existing in vitro and small trial data suggest Dazhu hongjingtian injection (DZHJTI) benefits acute ischemic stroke (AIS).
• Generalizability of these positive effects to routine clinical practice requires further investigation.

Purpose of the Study:

• To evaluate the real-world effectiveness of DZHJTI for AIS, focusing on neurological deficit changes.
• To assess DZHJTI's safety profile, including adverse events and vital sign monitoring.
• To determine the impact of DZHJTI on mortality, vascular events, disability, and Traditional Chinese Medicine syndromes.

Main Methods:

• A prospective, multicenter cohort study involving 2000 AIS patients within 14 days of symptom onset across 30 Chinese hospitals.
• A 6-month follow-up period to assess the primary outcome (change in National Institute of Health Stroke Scale score) and secondary outcomes.
• Utilizing an augmented inverse propensity weighted estimator to enhance the accuracy of treatment effect estimations.

Main Results:

• Clinical trial registration approved October 2022; participant recruitment began November 2022.
• Study outcomes are anticipated for publication in 2025 in peer-reviewed health journals.
• No results available yet as the study is ongoing.

Conclusions:

• This real-world cohort study is the first to comprehensively evaluate DZHJTI's effectiveness and safety in AIS treatment.
• Results are expected to offer crucial clinical evidence on response duration, long-term efficacy, and subgroup effects.
• Findings will aid clinicians and patients in optimizing AIS treatment strategies and improving patient outcomes.