Cilostazol Stroke Prevention Study for Antiplatelet Combination
Cilostazol Stroke Prevention Study for Antiplatelet Combination
To examine the efficacy and safety of dual antiplatelet therapy (DAPT) including cilostazol
 (Pletaal OD Tablet ®) in comparison with antiplatelet monotherapy (excluding cilostazol) for
 secondary prevention of ischemic stroke in high-risk patients for stroke
Inclusion Criteria:

 -  Patients with a diagnosis of noncardioembolic IS that developed between 8 and 180 days
 before the start of the protocol treatment

 -  Patients with a responsible lesion identified by MRI

 -  Patients aged 20 to 85 years old when providing informed consent

 -  Patients taking clopidogrel or aspirin alone as antiplatelet therapy when providing
 informed consent

 -  Patients meeting at least one of the following criteria a-c:

 1. at least 50% stenosis of a major intracranial artery (to the level of A2, M2, or
 P2)

 2. at least 50% stenosis of an extracranial artery (the common carotid
 artery，internal carotid artery，vertebral artery，brachiocephalic artery，or
 subclavian artery)

 3. Two or more of the following risk factors

 -  Aged 65 years or more

 -  Diabetes mellitus

 -  Hypertension

 -  Peripheral arterial disease

 -  Chronic kidney disease

 -  History of IS (excluding the index IS for this study)

 -  History of ischemic heart disease

 -  Smoking (only current smokers)

 -  Patients considered to be able to visit the study site for ambulatory care throughout
 the observation period

 -  Patients who provided written informed consent

 Exclusion Criteria:

 -  Patients with emboligenic heart disease

 -  Patients taking any anticoagulant agents

 -  Patients who cannot undergo MRI examination for reasons such as claustrophobia and
 implanted pacemaker

 -  Patients scheduled to undergo any surgery, such as percutaneous angioplasty, stent
 placement, and bypass grafting, during the study period

 -  Patients with a drug-eluting coronary stent implanted within one year

 -  Patients with a history of symptomatic non-traumatic intracranial hemorrhage, any
 other hemorrhagic disease (eg, active peptic ulcer), bleeding predisposition, or blood
 clotting disorders

 -  Patients with a history of hypersensitivity to cilostazol

 -  Patients with congestive heart failure or uncontrolled angina pectoris

 -  Patients with thrombocytopenia (platelet count ≦ 100,000/mm3)

 -  Patients with severe liver or renal dysfunction

 -  Women who are pregnant, breast-feeding, or of child-bearing potential

 -  Patients with a malignant tumor requiring treatment

 -  Patients who are taking aspirin, and meet any of the following criteria:

 -  History of hypersensitivity to aspirin or salicylic acid analogues

 -  Current peptic ulcer

 -  Aspirin-induced asthma or its history

 -  Patients who are taking clopidogrel, and meet the following criterion:

 ・History of hypersensitivity to clopidogrel

 -  Patients who are participating in any other clinical studies

 -  Patients considered by the investigator/subinvestigator to be unsuitable for
 participating in this study