Optimal Antithrombotic Therapy in Ischemic Stroke Patients with Non-Valvular Atrial Fibrillation and Atherothrombosis (ATIS-NVAF)

Recruitment & Eligibility

Status: Suspended

Sex: All

Target Recruitment: 400

Inclusion Criteria

1. Patients with an acute ischemic stroke or TIA from 15 days and up to 180 days from the onset of symptoms
2. Age 20 or older
3. Patients with nonvalvular atrial fibrillation (chronic or paroxysmal) who start or continue taking an oral anticoagulant
4. Patients who have one of the following atherothrombotic diseases
(1) A past history of ischemic heart disease, myocardial infarction, angina pectoris, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI)
(2) A past history of peripheral artery disease (symptomatic peripheral arterial occlusive disease, lower extremity bypass surgery/angioplasty/stenting)
(3) Carotid artery stenosis (symptomatic or asymptomatic (=>50% diameter), a history of carotid artery stenting (CAS) or carotid endarterectomy (CEA)
(4) 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)
(5) 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

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.Patients with a history of symptomatic intracranial hemorrhage or gastrointestinal bleeding within the past 6 months
5.Patients with hemorrhagic diathesis or blood coagulation disorders
6.Patients with platelet counts <100,000 /m m3 at enrollment.
7.Patients with severe anemia (hemoglobin <7 g/dL)
8.Patients with severe renal failure (creatinine clearance =<15 mL/min) or who are undergoing chronic hemodialysis.
9.Patients with 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.Patients with active cancer
13.Patients with expectation of survival less than 2 years
14.Patients in whom anticoagulant or antiplatelet is scheduled to be discontinued for more than 4 weeks during the follow-up period
15.Patients with a 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

Secondary Outcome Measures

Name	Time	Method

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