Study on Yangxue Nao Granules Reducing the Risk of Stroke

Cerebral Infarction Clinical Trial

Official title:

A Real World Study of Yangxuenao Granules Reducing Bleeding Risk in Patients With Acute Ischemic Stroke Treated With Intravenous Thrombolysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04949906
• Other study ID #: M2019439
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 1, 2020
• Est. primary completion date: September 1, 2020
• Gender: All
• Age group: N/A and older

Eligibility

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.

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;

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Intervention

Drug:
• Raise serum brain granules
Should Yangseronao granules be used in patients undergoing intravenous thrombolysis for the diagnosis of acute ischemic stroke
• No nourishing serum brain granules are used
No nourishing serum brain granules are used

Locations

Country	Name	City	State
China	Peking Yniversity Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microhemorrhage (CMB) of T2* sequence in MRI after thrombolysis	The number of CMB is an important imaging marker reflecting microvascular injury.	1 day