Table 2.

Inclusion and exclusion criteria

Inclusion criteria: 1) Clinical diagnosis of noncardioembolic IS that developed between 8 and 180 days before the start of the protocol treatment 2) A responsible lesion identified on MRI 3) Age 20–85 years 4) Taking clopidogrel or aspirin alone as antiplatelet therapy when providing informed consent 5) At least one of the following (a–c): a. ≥50% stenosis of a major intracranial artery (to the level of A2, M2, or P2) b. ≥50% stenosis of an extracranial artery (the common carotid artery, internal carotid artery, vertebral artery, brachiocephalic artery, or subclavian artery) c. Two or more of the following risk factors – Age ≥ 65 years – Diabetes mellitus – Hypertension – Peripheral arterial disease – Chronic kidney disease – History of IS (excluding the index IS for this trial) – History of ischemic heart disease – Smoking (only current smokers) 6) Considered to be able to visit the trial site for ambulatory care throughout the observation period 7) Written informed consent by the patient

Exclusion criteria: 1) High-risk sources of cardioembolism, according to the TOAST classification 2) Using any anticoagulants 3) Contraindication to MRI examination, such as claustrophobia or implanted pacemaker 4) Scheduled to undergo any surgery, such as percutaneous angioplasty, stent placement, and bypass grafting, during the trial period 5) Drug-eluting coronary stent implanted within one-year 6) History of symptomatic nontraumatic intracranial hemorrhage, any other hemorrhagic disease, bleeding predisposition, or blood clotting disorders 7) History of hypersensitivity to cilostazol 8) Congestive heart failure or uncontrolled angina pectoris 9) Thrombocytopenia (platelet count, ≤ 100,000/mm3) 10) Severe liver or renal dysfunction 11) Pregnant, breast-feeding, or of child-bearing potential 12) Malignant tumor requiring treatment 13) Aspirin user meeting any of the following criteria: History of hypersensitivity to aspirin or salicylic acid analogues Current peptic ulcer Aspirin-induced asthma or its history 14) Clopidogrel user with a history of hypersensitivity to clopidogrel 15) Participating in any other clinical studies 16) Unsuitable for trial enrollment, as judged by the investigator

TOAST, the Trial of Org 10172 in Acute Stroke Treatment.