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

  • STATUS
    Recruiting
  • End date
    Apr 30, 2026
  • participants needed
    400
  • sponsor
    National Hospital Organization Osaka National Hospital
Updated on 26 January 2021
Investigator
Hiroshi Yamagami, MD
Primary Contact
National Hospital Organization Osaka National Hospital (7.6 mi away) Contact
+1 other location
carotid artery stenosis
stenosis
aspirin
stroke
warfarin
anticoagulants
atrial fibrillation
heart disease
infarct
percutaneous coronary intervention
antiplatelet agents
rivaroxaban
fibrillation
coronary artery bypass graft
apixaban
edoxaban
dabigatran

Summary

Previous studies provide a rationale for administration of AZA after allo SCT for decreasing chimerism. The investigators hypothesize that azacitidine can be well tolerated after SCT and help decrease rate of decreasing donor chimerism and hence decrease relapse without increasing GVHD

Details
Condition Arrhythmia, Atrial Fibrillation, Ischemic Stroke, Atherothrombosis, Atrial Fibrillation (Pediatric), Dysrhythmia
Treatment Oral Anticoagulant, Antiplatelet Drug, Antiplatelet Drug
Clinical Study IdentifierNCT03062319
SponsorNational Hospital Organization Osaka National Hospital
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with an acute ischemic stroke or TIA from 8 days and up to 360 days from the onset of symptoms
Age 20 or older
Patients with non-valvular atrial fibrillation (chronic or paroxysmal) who start or continue taking an oral anticoagulant
Patients who have one of the following atherothrombotic diseases
A past history of ischemic heart disease (myocardial infarction, angina pectoris, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI)
A past history of peripheral artery disease (symptomatic peripheral arterial occlusive disease, lower extremity bypass surgery/angioplasty/stenting)
Carotid artery stenosis (symptomatic or asymptomatic (=>50% diameter), a history of carotid artery stenting (CAS) or carotid endarterectomy (CEA))
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)
A past history of atherothrombotic brain infarction, lacunar infarction, or branch atheromatous disease
Patients without severe disability (modified Rankin Scale score =<4)
Patients who can take oral medications
Patients who can receive follow-up survey
Provision of written informed consent either directly or by a suitable surrogate

Exclusion Criteria

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