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

Peking University

Status: Active, not recruiting

Conditions: Stroke, Acute Ischemic

Treatments: Drug: Yangxue Qingnao Granules

Study type: Interventional

Funder types: Other

Identifiers

NCT06344312

M2023551

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

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

Treatment:

Drug: Yangxue Qingnao Granules

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Yangxue Qingnao Granules