Cerebral InfarctionNCT04949906
Study on Yangxue Nao Granules Reducing the Risk of Stroke
An observational study of Cerebral Infarction, run by Peking University Third Hospital at 1 site in China.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- Raise serum brain granules and No nourishing serum brain granules are used
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Cerebral Infarction
- Being tested
- Raise serum brain granules, No nourishing serum brain granules are used
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raise serum brain granulesDrug
Should Yangseronao granules be used in patients undergoing intravenous thrombolysis for the diagnosis of acute ischemic stroke
No nourishing serum brain granules are usedDrug
No nourishing serum brain granules are used
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | The application of raising serum brain granules Receives: Drug: Raise serum brain granules | |
| The control group | No nourishing serum brain granules are used Receives: Drug: No nourishing serum brain granules are used |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microhemorrhage (CMB) of T2* sequence in MRI after thrombolysis
The number of CMB is an important imaging marker reflecting microvascular injury.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Jun 2019
- Primary completion1 Sep 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949906
- Sponsor's protocol ID
- M2019439
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Study of Yangxuenao Granules Reducing Bleeding Risk in Patients With Acute Ischemic Stroke Treated With Intravenous Thrombolysis
- ClinicalTrials.gov ID
- NCT04949906
- Acronym / sponsor ID
- M2019439
- Conditions
- Cerebral Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | – | Drug: Raise serum brain granulesThe application of raising serum brain granules |
| The control group | – | Drug: No nourishing serum brain granules are usedNo nourishing serum brain granules are used |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raise serum brain granulesShould Yangseronao granules be used in patients undergoing intravenous thrombolysis for the diagnosis of acute ischemic stroke | Drug | The experimental group |
| No nourishing serum brain granules are usedNo nourishing serum brain granules are used | Drug | The control group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Infarction, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microhemorrhage (CMB) of T2* sequence in MRI after thrombolysis (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.