The Purpose of this open-label randomized controlled multicenter trial is to evaluate the efficacy and safety of mono-drug therapy with oral anticoagulant compared to combination therapy with antiplatelet drug, in ischemic stroke patients with non-valvular atrial fibrillation and atherothrombosis.
The Purpose of this open-label randomized controlled multicenter trial is to evaluate the efficacy and safety of mono-drug therapy with oral anticoagulant compared to combination therapy with antiplatelet drug, in ischemic stroke patients with non-valvular atrial fibrillation and atherothrombosis. Target sample size is 400. The primary outcome is a composite endpoint of ischemic cardiovascular events (cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, ischemic events requiring urgent revascularization) and major bleeding defined by the International Society on Thrombosis and Haemostasis(ISTH) criteria within 2 years after randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
321
warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban
aspirin, clopidogrel, prasugrel, ticlopidine, or cilostazol
National Hospital Organization Osaka National Hospital
Osaka, Osaka, Japan
Composite endpoint of ischemic cardiovascular events and major bleeding
One of the following ischemic cardiovascular events (cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, or ischemic events requiring urgent revascularization), or major bleeding defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria
Time frame: 2 years after randomization
All-cause mortality
All-cause mortality
Time frame: 2 years after randomization
Ischemic cardiovascular events
Ischemic cardiovascular events (cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, ischemic events requiring urgent revascularization)
Time frame: 2 years after randomization
All ischemic cardiovascular events including transient ischemia
All ischemic cardiovascular events including transient ischemia (cardiovascular death, ischemic stroke, transient ischemic attack (TIA), myocardial infarction, unstable angina pectoris, systemic embolism, progression of symptomatic peripheral artery disease, ischemic events requiring urgent revascularization)
Time frame: 2 years after randomization
Ischemic stroke
Ischemic stroke
Time frame: 2 years after randomization
Myocardial infarction and cardiovascular death
Myocardial infarction and cardiovascular death
Time frame: 2 years after randomization
major bleeding
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major bleeding defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria
Time frame: 2 years after randomization
Intracranial hemorrhage
Intracranial hemorrhage
Time frame: 2 years after randomization