Study on Yangxue Nao Granules Reducing the Risk of Stroke

July 2, 2021 updated by: Peking University Third Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking Yniversity Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The experimental group
The application of raising serum brain granules
Drug: Raise serum brain granules
Should Yangseronao granules be used in patients undergoing intravenous thrombolysis for the diagnosis of acute ischemic stroke
The control group
No nourishing serum brain granules are used
Drug: No nourishing serum brain granules are used
No nourishing serum brain granules are used

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microhemorrhage (CMB) of T2* sequence in MRI after thrombolysis
Time Frame: 1 day
The number of CMB is an important imaging marker reflecting microvascular injury.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

June 27, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 2, 2021

Study Record Updates

Last Update Posted (Actual)

July 6, 2021

Last Update Submitted That Met QC Criteria

July 2, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2019439

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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