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:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT05849805
Eligibility Criteria:
Inclusion Criteria:
1.18-75 years old; 2.No gender limitation; 3.Pre-stroke mRS score \<2 4. Randomization can be finished within 24 hours of stroke onset (onset time is defined as last-seen-well time) 5. Ischemic stroke in the middle cerebral artery(MCA) territory meeting the following characteristics: A. 15\<NIHSS≤30 B. Imaging within 6h of onset indicated the core area of infarction (rCBF\<30% volume in CTP)\>1/2 MCA territory or ASPECTS score≤6 6.If endovascular-reperfusion therapy is performed, the treatment is not effective with one of the following conditions: A. The NIHSS score decreased≤4 and the total score was still\>15 B. The NIHSS score progressed immediately after the therapy and the total score≤30 7. Informed consent signed
Exclusion Criteria:
1. Concurrent with one of the other cerebrovascular diseases of the following conditions:
A.Acute cerebral hemorrhage or subarachnoid hemorrhage B. Acute posterior circulation infarction C.Other types of TOAST classification such as intracranial artery dissection, vasculitis and moyamoya disease
2. Hemorrhagic transformation in the infarct area, over 30% of the infarct area, and significant occupancy effect
3. Bilateral pupil fixation / pupillary reflex disappeared
4. Decompressive craniectomy was planned before randomization
5. Resistant hypertension (systolic\> 200mmHg or diastolic\> 110mmHg) or hypotension (systolic \<70mmHg or diastolic \<50mmHg)
6. Abnormal blood glycemia before randomization (random venous blood glucose \<2.8 mmol/L or\> 23 mmol/L)
7. Severe hepatic or renal insufficiency (Note: severe hepatic insufficiency refers to the ALT\> 3 times the upper limit of normal or the AST \> 3 times the upper limit of normal; severe renal insufficiency means the creatinine value\> 1.5 times the upper limit of normal or GFR \<40 ml/min/1.73m2)
8. Severe cardiac insufficiency before randomization (compliance with New York College of Cardiology (NYHA) Cardiac Function Class III, IV)
9. Dual antiplatelet (aspirin plus clopidogrel or ticagrelor or cilostazol) within 24 hours or tirofiban within 4 hours
10. Combining with contraindications for intra-diplo administration, such as skull fracture, skull infection, subdural / external hematoma, subscalp hematoma, scalp skin or subcutaneous infection, etc
11. Bleeding tendency (including but not limited to): platelet count \<100×109 / L; received heparin within nearly 24h, APTT ≥35s; oral warfarin, INR\>1.7; new-oral-anticoagulant orally; with direct thrombin or factor Xa inhibitor; Combining with coagulopathy such as hemophilia
12. presence of severe or very severe anemia (hemoglobin \<60g / L)
13. Combining with respiratory failure, and still difficult to correct after endotracheal intubation or tracheotomy, requiring ventilator treatment
14. Combining with severe CNS degenerative disease, such as AD, PD and severe dementia from various causes
15. Combining with other organic diseases, such as malignancy, the patient's life expectancy is less than 3 months
16. Allergy to any component of the therapeutic drug
17. Other neuroprotective agents without guideline recommendations and with unknown mechanism of the most important component were used within 24 hours of onset
18. Patients with pregnancy, lactation, or a possible pregnancy and a planned pregnancy
19. Unable to comply with the trial protocol or follow-up requirements
20. Other circumstances deemed unsuitable by investigator
21. Also participate in other interventional clinical trials
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05849805
Study Brief:
Protocol Section:
NCT05849805