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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke, Acute Ischemic
• Intervention / Treatment: Drug: Yangxue Qingnao Granules

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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; 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.
Placebo Comparator: Control Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment	90 days

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Brain Infarction; Infarction; Stroke; Ischemic Stroke; Hemorrhage; Cerebral Infarction
• Other Study ID Numbers: M2023551

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No