Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke (AGREE)
Ischemic Stroke
About this trial
This is an interventional treatment trial for Ischemic Stroke
Eligibility Criteria
Inclusion Criteria: Aged 40-80 years. Diagnosed with acute ischemic stroke, NIHSS ≤ 5 and single item score ≤ 1 for vision, language, single limb, and no impairment of consciousness. Time from symptoms onset to randomization within 4.5 hours; the onset time refers to the "Last Known Normal" (LKN). Absence of large vessel occlusion on CTA. Pre-stroke mRS ≤ 1. Signed informed consent. Exclusion Criteria: Clinically confirmed valvular or non-valvular atrial fibrillation requiring anticoagulation therapy. Intracranial hemorrhage or subarachnoid hemorrhage suggested by CT scan. Acute coronary syndrome suggested by Electrocardiogram. History of gastrointestinal bleeding. Planned sequential IVT or endovascular treatment. History of allergy to aspirin, clopidogrel, and/or alteplase. Systolic blood pressure exceeding 185 mmHg and/or diastolic blood pressure exceeding 110 mmHg despite antihypertensive treatment. Blood glucose ≤ 2.7 mmol/L. Epileptic seizures during a stroke attack. Recent trauma (<15 days). Recent intracranial or spinal cord surgery, head trauma, or stroke (<3 months). History of intracranial hemorrhage, aneurysm, vascular malformation, or brain tumor. Active visceral hemorrhage (<22 days). History of anticoagulant use within 24 hours prior to onset. Platelets <100,000, PTT > 40 seconds on heparin, or PT > 15 or INR > 1.7, or known bleeding disposition. Anticipated life expectancy < 3 months. Pregnant or lactating women. Participation in other clinical trials. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).
Sites / Locations
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
DAPT group
IVT group
Receiving dual antiplatelet therapy immediately after randomization (Oral aspirin 100mg+clopidogrel 300mg, Day 1). Participants who show no evidence of intracranial hemorrhage on skull CT 24 hours after randomization will receive oral aspirin 100mg/d (Day 2-90) and clopidogrel 75mg/d (Day 2-21), while those with intracranial hemorrhage on skull CT will not receive any antiplatelet drugs.
Receiving intravenous thrombolysis immediately after randomization (Intravenous alteplase, 0.9mg/kg, a maximum dosage of 90mg). Participants who show no evidence of intracranial hemorrhage on skull CT 24 hours after randomization will receive oral aspirin 100mg/d (Day 2-90), while those with intracranial hemorrhage on skull CT will not receive any antiplatelet drugs.