Table 1 Inclusion and exclusion criteria

Inclusion criteria

✧ Adult subjects (male or female ≥18 years old)

✧ Acute nondisabling ischemic stroke (NIHSS ≤3 at the time of randomization) that can be treated with study drug within 24 h of symptoms onset. Symptom onset is defined by the “last see normal” principle

✧ TIA (neurologic deficit attributed to focal brain ischemia, with resolution of the deficit within 24 h of symptom onset), that can be treated with investigational medication within 24 h of symptoms onset. Symptom onset is defined by the “last see normal” principle

✧ Informed consent signed

Exclusion criteria

✧ Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other major nonischemic brain disease, on baseline head CT or MRI scan

✧ mRS score >2 at randomization (premorbid historical assessment)

✧ NIHSS ≥4 at randomization

✧ Clear indication for anticoagulation (atrial fibrillation, mechanical cardiac valves, deep venous thrombosis, pulmonary embolism or known hypercoagulable state)

✧ Contraindication to investigational medications

✧ Thrombolysis for ischemic stroke within preceding 7 days

✧ History of intracranial hemorrhage

✧ Current treatment (last dose given within 10 days before randomization) with heparin therapy or oral anticoagulation

✧ Gastrointestinal bleed or major surgery within 3 months

✧ Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months

✧ TIA or minor stroke induced by angiography or surgery

✧ Severe noncardiovascular comorbidity with life expectancy <3 months

✧ Women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test result

✧ Severe renal failure, defined as Glomerular Filtration Rate (GFR) <30 ml/min

✧ Severe hepatic insufficiency (Child-Pugh score B to C)