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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,884
Aspirin (81mg or 100mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
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 one year after the first visit of the last subject.
Cilostazol (100mg twice daily) will be orally administered. The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
Japan Cardiovascular Research Foundation
Osaka, Japan
Recurrence of symptomatic ischemic stroke, with the symptoms lasting for at least 24 hours
An "ischemic stroke" hereafter indicates a symptomatic ischemic stroke.
Time frame: every 6 months
Any stroke [ischemic stroke (IS), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH)]
Time frame: every 6 months
SAH or ICH
Time frame: every 6 months
IS or transient ischemic attack (TIA)
Time frame: every 6 months
Death from any cause
Time frame: every 6 months
Stroke (IS,ICH,SAH), myocardial infarction (MI), or vascular death
Time frame: every 6 months
All vascular events: stroke, MI, and other vascular events
Time frame: every 6 months
Adverse events and adverse drug reactions
Time frame: every 6 months
Severe or life-threatening hemorrhage (GUSTO Criteria)
Time frame: every 6 months
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