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:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT06801457
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 80 years old;
* Signs and symptoms are consistent with a new acute stroke, with low possibility of stroke mimics (e.g., no sudden coma, prior seizure disorder, suspected hypoglycemia);
* No prior stroke;
* The time from stroke onset/last seen well to randomization is within 6 hours;
* Paramedic-obtained FAST-ED score \>= 3 (The enrollment of patients with a FAST-ED score of 3 is prespecified to constitute no more than 10% of the total study population);
* No significant pre-stroke disability (pre-stroke mRS 0-1);
* Signed informed consent from the patient or the legally authorized representative (LAR).
Exclusion Criteria:
* Endotracheal intubation in the field (prior to consent);
* Respiratory rate \<= 10 or \>= 30 breaths per minute;
* Oxygen-dependence at baseline to maintain SaO2 \> 95%;
* Known history of severe chronic obstructive pulmonary disease (FEV1 less than 1.0), New York Heart Association (NYHA) Heart Failure Class III, acute pulmonary infection or aspiration pneumonia, prior to enrollment;
* Seizure at stroke onset;
* Exhibiting symptoms of vomiting, severe headache, or unconscious;
* Known pregnancy: women of childbearing age (18 to 44 years old according to the CDC's Division of Reproductive Health) will be asked about their pregnancy status.
* Participating in another clinical trial, or completed participation within prior 30 days;
* Receiving other neuroprotective agent (e.g., edaravone dexborneol, n-butylphthalide);
* Life expectancy \< 90 days due to comorbidities;
* Unlikely to complete the 90-day follow-up visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06801457
Study Brief:
Protocol Section:
NCT06801457