Study on Yangxue Nao Granules Reducing the Risk of Stroke

Completed

• Conditions: Cerebral Infarction
• Interventions: Drug: Raise serum brain granules; Drug: No nourishing serum brain granules are used

• Registration Number: NCT04949906
• Lead Sponsor: Peking University Third Hospital

Brief Summary

Objective: To explore the effectiveness of raising serum nao granules in reducing the risk of bleeding in patients with acute ischemic stroke treated with intravenous thrombolysis in the real world

Detailed Description

Objective: To explore the effectiveness of raising serum nao granules in reducing the risk of bleeding in patients with acute ischemic stroke treated with intravenous thrombolysis in the real world Study Design. This study was a single center real world study. Through the review data, this study included in January 1, 2017 to September 30, 2019, see a doctor at Peking University third hospital neurology, emergency diagnosis of acute ischemic stroke, and venous thrombolysis in patients with a queue, on the basis of whether the application have serum brain particles are divided into a group and the control group, serum application parameters and nonparametric comparison, K-M curve and Cox regression model were used to evaluate the effectiveness of Yangxuenao granules in reducing bleeding conversion after intravenous thrombolysis by comparing the number of microbleeding, stroke severity score and modified Rankin score after 3 months follow-up with the weighted craniocerebral magnetic sensitivity imaging sequence reexamined within 48 hours.

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2020-09-01
• Study Completion: 2020-11-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-27
• Study First Submitted QC: 2021-07-01
• Study First Posted: 2021-07-02
• Last Update Submitted: 2021-07-02
• Last Update Posted: 2021-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• A cohort of patients admitted to the Department of Emergency Neurology at Peking University Third Hospital on January 1, 2017 and admitted on September 30, 2019, who were diagnosed with acute ischemic stroke and underwent intravenous thrombolysis.

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Exclusion Criteria

• Patients who underwent intravenous thrombolysis but were confirmed to be apoplexy
• like by imaging and other clinical examinations; Incomplete craniocerebral MRI examination;
• Bridging endovascular therapy;
• The previous application of Yangxuenao granules or other drugs with similar effects;

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The experimental group	Raise serum brain granules	The application of raising serum brain granules
The control group	No nourishing serum brain granules are used	No nourishing serum brain granules are used

Primary Outcome Measures

Name	Time	Method
Microhemorrhage (CMB) of T2* sequence in MRI after thrombolysis	1 day	The number of CMB is an important imaging marker reflecting microvascular injury.

Trial Locations

Locations (1)

Peking Yniversity Third Hospital; 🇨🇳 Beijing, China