Stroke, Acute Ischemic
Conditions
Brief 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
Interventions
DRUGYangxue 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.
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment | 90 days |
Countries
China
Outcome results
None listed