Ischemic Stroke Atrial Fibrillation Atherothrombosis
Conditions
Interventions
Dual-therapy group: single anticoagulant drug (warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban) and single antiplatelet drug (aspirin, clopidogrel, prasugrel, ticlopidine, or cilostazol) T
s package insert in Japan. In patients treated with warfarin, the target INR range of 2.0-3.0 for those <
70 years is recommended according to the Japanese guidelines.
Single-therapy group: single anticoagulant drug (warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban) The dosage is determined acc
70 years is recommended according to the Japanese guidelines.
Sponsors
National Hospital Organization Osaka National Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with an acute ischemic stroke or TIA from 8 days and up to 360 days from the onset of symptoms 2. Age: 20 years or more. 3. Patients with non-valvular atrial fibrillation (chronic or paroxysmal) who start or continue taking an oral anticoagulant 4. Patients who have one of the following atherothrombotic diseases a) A past history of ischemic heart disease (myocardial infarction, angina pectoris, coronary artery bypass graft (CABG), percutaneous coronary intervention(PCI) b) A past history of peripheral artery disease (symptomatic peripheral arterial occlusive disease, lower extremity bypass surgery/angioplasty/stenting) c) Carotid artery stenosis (symptomatic or asymptomatic (=>50% diameter), a history of carotid artery stenting (CAS) or carotid endarterectomy (CEA)) d) Intracranial artery stenosis (=>50% stenosis of the diameter of a major intracranial artery: intracranial internal carotid artery, anterior cerebral artery (ACA)-A1 and A2, middle cerebral artery (MCA)-M1 and M2, posterior cerebral artery (PCA)-P1 and P2, vertebral artery, and basilar artery; a history of intracranial stent placement or intracranial bypass surgery) e) A past history of atherothrombotic brain infarction, lacunar infarction, or branch atheromatous disease 5. Patients without severe disability (modified Rankin Scale score =<4) 6. Patients who can take oral medications 7. Patients who can receive follow-up survey 8. Provision of written informed consent either directly or by a suitable surrogate
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMisato Yasufuku
National Hospital Organization Osaka National Hospital Department of Neurology
Outcome results
None listed