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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT06638151
Eligibility Criteria:
Inclusion Criteria:
1. Participants must be \>18 years of age at the time of randomization
2. Acute non-cardioembolic ischemic stroke in the anterior circulation treated with reperfusion therapy defined as intravenous thrombolysis (IVT) and/or endovascular thrombectomy (EVT)
3. Time from end of acute reperfusion therapy to randomization ≤ 24 hours
4. Mild to moderate deficit defined as a National Institute of Health stroke scale of ≤11 at the time of randomization
5. At least one non-contrast CT scan completed post reperfusion therapy and prior to randomization without any hemorrhage (including hemorrhagic infarction) and/or contrast extravasation.
6. Premorbid mRS less than or equal to 2
7. Signed informed consent from the patient or legally authorized representative
Exclusion Criteria:
1. Any known disorder associated with a significantly increased risk of bleeding
2. Post-reperfusion CT scan ASPECT score \<8.
3. Anticoagulation is required for any indication other than DVT prophylaxis
4. Evidence-based indication for dual antiplatelet therapy
5. Planned surgical intervention in the next 90 days includes but is not limited to carotid endarterectomy, where dual antiplatelet is not indicated, and carotid stenting, where single antiplatelet is not used.
6. History of intracranial or subarachnoid hemorrhage
7. Intracranial tumour, arteriovenous malformation or aneurysm;
8. Intracranial or spinal cord surgery within three months;
9. Gastrointestinal or urinary tract hemorrhage within the previous 21 days;
10. Coagulation disorder, thrombocytopenia \<100, 000/mm3, and Prothrombin time INR ≥1.8
11. Index stroke is caused by infective endocarditis, dissection, systematic or central nervous system vasculitis
12. History of active malignancy being treated or life expectancy ≤ 90 days
13. Allergy to clopidogrel or aspirin
14. Pregnancy
15. Participation in another clinical trial.
16. The presence of a major co-morbid illness that would make it unlikely that the participant will be able to complete follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06638151
Study Brief:
Protocol Section:
NCT06638151