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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT03413202
Eligibility Criteria:
Inclusion Criteria:
* Age ranging from 18 to 80, both genders;
* Within 48 hours symptoms onset;
* According to TOAST classification, diagnosed to be large-artery atherosclerosis ischemic stroke, without history of stroke in the past three months;
* 5≤National Institutes of Health Stroke Scale (NIHSS) ≤25;
* Unilateral internal carotid artery (ICA) or M1 segment of middle cerebral artery (MCA) stenosis (rate of stenosis ranging from 50-99%);
* Sufficient bilateral temporal bone windows for insonation of the middle cerebral artery;
* Glasgow Coma Scale (GCS) ≥ 8;
* Willing to participate and sign the informed consent.
Exclusion Criteria:
* Patients who have received or plan to undergo intravascular interventional treatment/thrombolytic therapy;
* Coma or agitation, and can't cooperate to complete dCA;
* Has been given butylphthalide injection or capsules;
* Arrhythmia, anemia and hyperthyroidism which may influence the stability of cerebral blood flow diagnosed by two physicians by electrocardiogram and laboratory tests;
* Other intracranial diseases, including cerebral hemorrhage (primary or secondary), intracranial neoplasm, aneurysm, arteriovenous malformation, etc;
* Alanine transaminase (ALT) or glutamic-oxalacetic transaminase (AST) continued to rise more than 3 times the upper limit of normal , creatinine clearance rate\<30ml/min;
* Pre-stroke Modified Rankin Scale (mRS) score ≥ 2;
* Malignant neoplasm and expected lifetime \< 2 years;
* Pregnant and lactating women;
* Participating in other trials or has been participated in other trials in recent 3 months;
* Dementia and mental illness.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03413202
Study Brief:
Protocol Section:
NCT03413202