NCT04949906

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
Last Updated

July 6, 2021

Status Verified

June 1, 2021

Enrollment Period

1.3 years

First QC Date

June 27, 2021

Last Update Submit

July 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Microhemorrhage (CMB) of T2* sequence in MRI after thrombolysis

    The number of CMB is an important imaging marker reflecting microvascular injury.

    1 day

Study Arms (2)

The experimental group

The application of raising serum brain granules

Drug: Raise serum brain granules

The control group

No nourishing serum brain granules are used

Drug: No nourishing serum brain granules are used

Interventions

Should Yangseronao granules be used in patients undergoing intravenous thrombolysis for the diagnosis of acute ischemic stroke

The experimental group

No nourishing serum brain granules are used

The control group

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Yniversity Third Hospital

Beijing, China

Location

MeSH Terms

Conditions

Cerebral Infarction

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 2, 2021

Study Start

June 1, 2019

Primary Completion

September 1, 2020

Study Completion

November 1, 2020

Last Updated

July 6, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations