Effectiveness of Yangxue Qingnao Granules in Preventing Post Thrombolytic Hemorrhage Transformation in Patients With Acute Cerebral Infarction

April 1, 2024 updated by: Peking University Third Hospital

Effectiveness of Yangxue Qingnao Granules in Preventing Post Thrombolytic Hemorrhage Transformation in Patients With Acute Cerebral Infarction: a Randomized Controlled Study

Evaluate the effectiveness of Yangxue Qingnao Granules in preventing post thrombolytic hemorrhage transformation in patients with acute cerebral infarction, and explore its possible mechanism

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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 University 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 50 years old, regardless of gender
  • After the onset of this disease, the National Institutes of Research Stroke Scale score was 2 ≤ NIHSS ≤ 20 points
  • Patients who have developed symptoms within 4.5 hours and can receive rt PA intravenous thrombolysis treatment
  • According to the 2019 Diagnosis Points for Major Cerebrovascular Diseases in China, patients with ischemic stroke were diagnosed as having a good recovery from the first or last onset (mRS score ≤ 1 point before this onset)
  • Obtain the patient or their legal representative to voluntarily sign an informed consent form approved by the ethics committee.

Exclusion Criteria:

  • Intracranial hemorrhagic diseases seen on cranial imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc; If it is only oozing blood, the researcher can determine whether it is suitable for enrollment
  • Severe consciousness disorder: NIHSS scored>1 point in the 1a consciousness level item
  • After controlling the patient's blood pressure, the systolic blood pressure remains ≥ 180mmHg or the diastolic blood pressure remains ≥ 100mmHg
  • Blood glucose<2.8mmol/L (random blood glucose measurement device can be used)
  • Patients with severe mental disorders and dementia
  • Diagnosed with severe active liver diseases, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc; Or ALT or AST>2.0 x ULN
  • Diagnosed with severe active kidney disease and renal insufficiency; Or serum creatinine>1.5 × ULN
  • Concurrent malignant tumors or ongoing anti-tumor treatment; For subjects diagnosed with malignant tumors after enrollment, the decision to continue participating in the study can be based on the researcher's judgment and the subject's willingness
  • Suffering from severe systemic diseases, with an estimated survival time of<90 days
  • History of major surgery within 4 weeks prior to enrollment
  • Participated in other clinical studies within the first 30 days of randomization, or is currently participating in other clinical studies
  • The researcher believes that it is not suitable to participate in this clinical study
  • Patients who are allergic to any ingredient in the study drug

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
Randomly take 2 bags of Yangxue Qingnao Granules orally during intravenous thrombolysis with ateplase, and then take 1 bag of Yangxue Qingnao Granules three times a day for a total of 2 weeks
Drug: Yangxue Qingnao Granules
When receiving intravenous thrombolysis with ateplase, two bags of Yangxue Qingnao Granule Simulator were randomly taken orally. Afterwards, one bag of Yangxue Qingnao Granule/ Simulator was taken three times a day for a total of two weeks.
Placebo Comparator: Control Group
When receiving intravenous thrombolysis with ateplase, two bags of Yangxue Qingnao Granule Simulator were randomly taken orally. Afterwards, one bag of Yangxue Qingnao Granule Simulator was taken three times a day for a total of two weeks.
Drug: Yangxue Qingnao Granules
When receiving intravenous thrombolysis with ateplase, two bags of Yangxue Qingnao Granule Simulator were randomly taken orally. Afterwards, one bag of Yangxue Qingnao Granule/ Simulator was taken three times a day for a total of two weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment
Time Frame: 90 days
90 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M2023551

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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