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 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT07205328
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18 and 80 years old (inclusive), male or female ;
2. Diagnosed with ischemic stroke according to the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023";
3. The time from the onset of the disease to the expected administration of the investigational drug will be within 24 hours., including patients who have not received reperfusion therapy or those have received intravenous thrombolysis treatment;
4. The NIHSS score at admission is between 6 and 25 (inclusive), and the sum of the scores for the 5th（upper limb movement） and the 6th（ lower limb movement） is ≥ 2 points;
5. The mRS score before this onset of stroke is 0 to 1, and there are no obvious clinical symptoms and signs that affect the NIHSS score;
6. Able to understand and cooperate with the process of this study, and voluntarily sign the informed consent.
Exclusion Criteria:
1. Imaging examinations show concurrent intracranial hemorrhagic disorders: such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc. If there is minor bleeding, it could be determined based on the researcher's judgment whether the subject was suitable for inclusion;
2. After the onset of the disease, obvious consciousness disorders occurre, and the score of the NIHSS item for the 1a level of consciousness is \>1 point;
3. Transient ischemic attack (TIA);
4. This acute ischemic stroke requires endovascular treatment (including intravenous thrombolysis, mechanical thrombectomy, angioplasty);
5. At the time of admission, already known severe active kidney disease, renal insufficiency; or serum creatinine \> 1.5 × ULN;
6. Severe active liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis, etc.; or ALT or AST \> 2.0 × ULN;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07205328
Study Brief:
Protocol Section:
NCT07205328