Stroke, Acute IschemicNCT06344312
Effectiveness of Yangxue Qingnao Granules in Preventing Post Thrombolytic Hemorrhage Transformation in Patients With Acute Cerebral Infarction
A study testing Yangxue Qingnao Granules in people with Stroke, Acute Ischemic, run by Peking University Third Hospital at 1 site in China.
Trial summary
Evaluate the effectiveness of Yangxue Qingnao Granules in preventing post thrombolytic hemorrhage transformation in patients with acute cerebral infarction, and explore its possible mechanism Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke, Acute Ischemic
- What is being tested?
- Yangxue Qingnao Granules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jun 2025
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Stroke, Acute Ischemic
- Being tested
- Yangxue Qingnao Granules
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yangxue Qingnao GranulesDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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 Receives: Drug: Yangxue Qingnao Granules |
| Control Group | Placebo comparator | 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. Receives: Drug: Yangxue Qingnao Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, Acute IschemicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
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
- NCT06344312
- Sponsor's protocol ID
- M2023551
- Status last verified
- Jan 2024
- First submitted
- 25 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Yangxue Qingnao Granules in Preventing Post Thrombolytic Hemorrhage Transformation in Patients With Acute Cerebral Infarction: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06344312
- Acronym / sponsor ID
- M2023551
- Conditions
- Stroke, Acute Ischemic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 3 Apr 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Yangxue Qingnao GranulesRandomly 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 |
| Control Group | Placebo comparator | Drug: Yangxue Qingnao GranulesWhen 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Yangxue Qingnao GranulesWhen 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 | Control Group, Experimental group |
Primary outcome
The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Yangxue Qingnao Granules in people with Stroke, Acute Ischemic, 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment (time frame: 90 days). 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 3 Apr 2024.