Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT06344312
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT06344312
Study Brief:
Protocol Section:
NCT06344312