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

NCT06344312 | Unknown

• 1 other identifier: M2023551
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke, Acute Ischemic

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment

  90 days

Study Arms (2)

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

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.

Drug: Yangxue Qingnao Granules

Interventions

Yangxue Qingnao Granules DRUG

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.

Control Group; Experimental group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 3, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-01

Locations

CN (1)