Clinical trial NCT06344312: Effectiveness of Yangxue Qingnao Granules in Preventing Post Thrombolytic Hemorrhage Transformation in Patients With Acute Cerebral Infarction
Official title: Effectiveness of Yangxue Qingnao Granules in Preventing Post Thrombolytic Hemorrhage Transformation in Patients With Acute Cerebral Infarction: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke, Acute Ischemic
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
References: