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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT06331494
Eligibility Criteria:
Inclusion Criteria:
1. Female or male aged 55-75 years;
2. At least one of the following risk factors of atherosclerosis: hypertension, diabetes, hypercholesterolemia, or smoking;
3. Symptomatic atherosclerotic stenosis in middle cerebral artery: large artery atherosclerotic cerebral infarction or TIA within 7 days of onset; 70%-99% stenosis of the responsible middle cerebral artery \[M1\] confirmed by high-resolution MRI examination (referred to Warfarin-Aspirin Symptomatic Intracranial Disease standard); new-onset infarction confirmed by diffusion weighted imaging (DWI) or TIA symptoms in the territory of the responsible artery supply;
4. NIHSS ≤ 20;
5. mRS ≤ 2 at randomization (pre-morbid historical assessment);
6. Participants understand the purpose of the study and have signed informed consent form.
Exclusion Criteria:
1. Presence of intracranial hemorrhage or other pathological brain diseases;
2. Plan to or have performed intravenous thrombolysis or mechanical thrombectomy therapy;
3. Unable to undergo MRI examination;
4. Use Butylphthalide during onset between randomization;
5. Suspect of cardiac embolism, such as atrial fibrillation, artificial heart valves, endocarditis, etc;
6. Contraindications for the use of clopidogrel or aspirin;
7. Known allergy history of celery or butylphthalide;
8. Severe liver dysfunction (aspartate aminotransferase or alanine transaminase \> 2 times normal upper limit) or severe renal dysfunction (creatinine value \> 1.5 times normal upper limit), heart failure, asthma, etc;
9. History of intracranial hemorrhage, coagulation disorders, systemic bleeding, thrombocytopenia, or other hematological disorders;
10. Plan to perform other surgical procedures or interventional treatments that may require termination of investigational drug use;
11. Severe non-cerebrovascular diseases with an expected survival time less than 3 months;
12. Actively participating in another drug or device trial;
13. Use any drugs with the same or similar mechanism as Butylphthalide during the follow-up period;
14. Unsuitable for this trial from the opinion of the investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
75 Years
Study:
NCT06331494
Study Brief:
Protocol Section:
NCT06331494