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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT06853535
Eligibility Criteria:
Inclusion Criteria:
* 1.Aged between 18 and 80 years old; 2.Diagnosed with non-cardiogenic ischemic stroke or TIA according to WHO criteria, confirmed by cranial CT or MRI to exclude hemorrhagic stroke.; 3.This stroke onset is ≤ 48 hours; (The duration of onset is defined as the time from the last time the patient was seen normal to the time of taking 300 mg of clopidogrel and 100 - 300 mg of aspirin in combination) 4.The NIHSS score is ≤ 5 points before randomization, or for TIA patients, the ABCD2 score is ≥ 4 points; 5.Within 48 hours after the patient's onset, 5 - 20 hours after receiving anti - platelet therapy with a combination of 300 mg of clopidogrel and 100 - 300 mg of aspirin, the measured MARADP is ≥ 35%; 6.The patient or their family member signs a written informed consent form.
Exclusion Criteria:
* 1.Imaging examination indicates hemorrhagic stroke or hemorrhagic transformation.
2.There is a history of diseases such as atrial fibrillation, left ventricular thrombosis, cardiomyopathy or valvular disease.
3.There are the following congenital heart diseases: patent foramen ovale, ventricular septal defect, atrial septal defect and tetralogy of Fallot.
4.Other P2Y12 receptor inhibitors (e.g., ticagrelor, prasugrel) except clopidogrel have been taken within 7 days.
5.There is a history of gastrointestinal bleeding, intracranial bleeding, recent massive bleeding or blood transfusion (excluding a small amount of hemoptysis and a small amount of abnormal vaginal bleeding), as well as a history of other hemorrhagic diseases caused by abnormal blood coagulation function (such as purpura, etc.).
6.There are contraindications or intolerance to anti - platelet drugs. 7.Patients with severe cardiac, pulmonary, hepatic and renal insufficiency, and those with serious comorbidities (e.g., cancer, chronic obstructive pulmonary disease, severe dementia, severe heart failure).
8.Those with poor compliance who cannot cooperate to meet the requirements of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06853535
Study Brief:
Protocol Section:
NCT06853535