Optimal Antithrombotic Therapy in Ischemic Stroke Patients with Non-Valvular Atrial Fibrillation and Atherothrombosis

Recruitment & Eligibility

Status: Complete: follow-up continuing

Sex: All

Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients with a history of myocardial infarction or acute coronary syndrome within the past 12 months 2. Patients who underwent PCI with drug-eluting stents within the past 12 months or PCI with bare-metal stents within the past 3 months 3. Patients who underwent carotid artery stent placement, intracranial stent placement, or lower extremity stent placement within the past 3 months 4. History of symptomatic intracranial hemorrhage or gastrointestinal bleeding within the past 6 months 5. Hemorrhagic diathesis or blood coagulation disorders 6. Platelet counts <100,000 /mm3 at enrollment. 7. Severe anemia (hemoglobin <7 g/dL) 8. Severe renal failure (creatinine clearance =<15 mL/min) or who are undergoing chronic hemodialysis. 9. Severe liver dysfunction (Grade B or C of the Child-Pugh classification) 10. Patients with severe disability requires constant nursing care, bedridden (modified Rankin Scale score =5) 11. Pregnant or possibly pregnant women 12. Active cancer 13. Expectation of survival less than 2 years 14. Anticoagulant or antiplatelet is scheduled to be discontinued for more than 4 weeks during the follow-up period 15. Planned revascularization procedure during the follow-up period 16. Patients who are enrolled in other trials 17. Patients judged as inappropriate for this study by investigators

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Incidences of following events within 2years after randomization: * All-cause mortality * Ischemic cardiovascular events (cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, ischemic events requiring urgent revascularization) * 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) * Ischemic stroke * Myocardial infarction and cardiovascular death * ISTH major bleeding * ISTH major bleeding and clinically relevant non-major bleeding * Intracranial hemorrhage

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