Noncardioembolic cerebral infarction
Conditions
Interventions
Monotherapy group: Aspirin (81mg or 100mg) or clopidogrel (50mg or 75mg) will be orally administered once daily. The treatment period will begin with the first visit of the first subject and end on
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with a diagnosis of noncardioembolic IS that developed between 8 and 180 days before the start of the protocol treatment 2) Patients with a responsible lesion identified by MRI 3) Patients aged 20 to 85 years old when providing informed consent 4) Patients taking clopidogrel or aspirin alone as antiplatelet therapy when providing informed consent 5) Patients meeting at least one of the following criteria a-c: a. at least 50% stenosis of a major intracranial artery (to the level of A2, M2, or P2) b. at least 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 - 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) 6) Patients considered to be able to visit the study site for ambulatory care throughout the observation period 7) Patients who provided written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with emboligenic heart disease 2) Patients taking any anticoagulant agents 3) Patients who cannot undergo MRI examination for reasons such as claustrophobia and implanted pacemaker 4) Patients scheduled to undergo any surgery, such as percutaneous angioplasty, stent placement, and bypass grafting, during the study period 5) Patients with a drug-eluting coronary stent implanted within one year 6) Patients with a history of symptomatic non-traumatic intracranial hemorrhage, any other hemorrhagic disease (eg, active peptic ulcer), bleeding predisposition, or blood clotting disorders 7) Patients with a history of hypersensitivity to cilostazol 8) Patients with congestive heart failure or uncontrolled angina pectoris 9) Patients with thrombocytopenia (platelet count <= 100,000/mm3) 10) Patients with severe liver or renal dysfunction 11) Women who are pregnant, breast-feeding, or of child-bearing potential 12) Patients with a malignant tumor requiring treatment 13) 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 14) Patients who are taking clopidogrel, and meet the following criterion: - History of hypersensitivity to clopidogrel 15) Patients who are participating in any other clinical studies 16) Patients considered by the investigator/subinvestigator to be unsuitable for participating in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence of symptomatic ischemic stroke,with the symptoms lasting for at least 24 hours (An "ischemic stroke" hereafter indicates a symptomatic ischemic stroke.) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy - Any stroke [ischemic stroke (IS), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH)] - SAH or ICH - IS or transient ischemic attack (TIA) - Death from any cause - Stroke (IS,ICH,SAH), myocardial infarction (MI), or vascular death - All vascular events: stroke, MI, and other vascular events (e.g. aortic dissection or rupture; pulmonary embolism; heart failure, angina pectoris, or occlusive arteriosclerosis requiring hospitalization; revascularization of coronary artery, aorta, peripheral artery, etc.) Safety - Adverse events and adverse drug reactions - Severe or life-threatening hemorrhage (GUSTO Criteria) | — |
Countries
Japan
Contacts
Public ContactMinoru Ido
Japan Cardiovascular Research Foundation Cilostazol Stroke Prevention Study. Combination secretariat
Outcome results
None listed