An observational study in Ischemic Stroke, Acute, sponsored by Dongzhimen Hospital, Beijing. Completed at 78 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Dongzhimen Hospital, Beijing · Observational
Acute ischemic stroke is one of the main diseases leading to high risk of disability and morbidity worldwide. Since intravenous thrombolysis(IVT) can effectively improve the long-term functional prognosis of acute ischemic stroke(AIS), IVT within 4.5 hours of onset has been widely recommended by international guidelines.
Although 35-53% of AIS patients achieve functional independence after receiving IVT, there are still a large number of patients who are disabled or even dead, and nearly 70% of patients have ineffective recanalization. Therefore, there is an urgent need for therapeutic drugs after IVT to further improve the prognosis and reduce the burden of AIS.
Shuxuetong injection is widely used in China in patients with AIS after IVT, but the situation in real clinical practice is unclear. Therefore, the study aims to evaluate the effectiveness and safety of Shuxuetong Injection in patients with AIS treated with intravenous alteplase and tenecteplase, and obtain high-quality clinical evidence.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's enrollment of 2,408 is above the median of 300 across 777 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Dongzhimen Hospital, Beijing is the lead sponsor of 43 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with acute ischemic stroke who received alteplase or tenecteplase within 4.5 hours of onset
Exclusion Criteria:
The exposure group was defined as patients receiving Shuxuetong injection and guideline-standardized treatment after intravenous alteplase or tenecteplase. Mainly based on the following guidelines:(1)Guidelines for the diagnosis and treatment of acute ischemic stroke in China 2018; (2)Guidelines for secondary prevention of ischemic stroke and transient ischemic attack in China 2022.
Drug: Shuxuetong Injection
The non-exposed group was defined as patients receiving guideline-standardized treatment after intravenous alteplase or tenecteplase.
According to clinical real treatment records
Proportion of mRS (0-1)
The modified Rankin Scale (mRS) score ranges from 0 (best score) to 6 (worst score).
Time frame: 90±7 days
Proportion of mRS (0-2)
Time frame: 90±7 days
Proportion of mRS (0-1) or returning to baseline
Time frame: 90±7 days
Distribution of mRS
Time frame: 90±7 days
Change of NIHSS
The change in the National Institute of Health Stroke Scale (NIHSS) scores from baseline to 14 days or the day of discharge. The NIHSS score ranges from 0 (best score) to 42 (worst score).
Time frame: baseline, 14 days or the day of discharge
BI
The Barthel Index (BI) score ranges from 0 (worst score) to 100 (best score).
Time frame: 90±7 days
Total mortality
The occurrence of mortality of any cause within 90 days.
Time frame: Within 90 days
Serious Adverse Events
The occurrence of serious adverse events including any event resulting in prolonged hospital time, permanent damage to the body system or organ, a life-threatening condition or death within 90 days.
Time frame: Within 90 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Dongzhimen Hospital, Beijing