Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke

The ATAMIS study is a multicentre, prospective, randomised, open-label, controlled trial with a target enrollment of 3,000 patients from 60 centres of the Northeast China. Eligible patients are as follows: (1) definite acute ischemic stroke; (2) neurological deficit: 4 ≤ NIHSS ≤ 10; (3) time from onset to drug treatment: within 48 hours.

Patients in the clopidogrel-aspirin group will receive a 300mg loading dose of clopidogrel, followed by clopidogrel 75 mg/d and aspirin 75 mg/d from day 2 to day 14, and followed by clopidogrel 75 mg/d or aspirin 100 mg/d from day 15 to day 90.

Patients in the aspirin-alone group will receive 100-300 mg aspirin from day 1 to day 14, followed by aspirin 100 mg/d from day 15 to day 90.

The primary efficacy end point is early neurological deterioration assessed as a change of NIHSS: no change of NIHSS within 14 days.

Inclusion criteria

• Age ≥ 18 years
• Acute ischemic stroke that can be randomized within 48 hours of symptoms onset
• neurological deficit: 4 ≤ NIHSS ≤ 10
• CT or MRI scan ruling out hemorrhage or other pathology
• the first onset of ischemic stroke or previous stroke with no obvious sequelae (mRS≤1)
• Signed informed consent by patient self or legally authorized representatives

Exclusion criteria

• intracranial hemorrhage and hemorrhagic cerebral infarction
• Thrombolysis for ischemic stroke
• Allergy to clopidogrel and/or aspirin
• History of stroke with serious sequelae
• Severe systemic disease (such as severe infection, severe hepatic and renal dysfunction)
• Clear indication for anticoagulation (atrial fibrillation, mechanical cardiac valves, deep venous thrombosis, pulmonary embolism)
• History of intracranial hemorrhage
• Planned treatment with nonsteroidal anti-inflammatory drugs to affect platelet function
• Anticoagulation within 10 days
• Gastrointestinal bleed or major surgery within 3 months
• Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months
• Planned surgery or intervention to stop antiplatelet therapy
• Ischemic stroke induced by angiography or surgery
• Pregnancy or childbirth within the previous 4 weeks
• Patients who have been treated with any other investigational drug within 3 months of enrollment
• Severe noncardiovascular comorbidity with life expectancy <3 months