Phase
Condition
Dysrhythmia
Blood Clots
Cerebral Ischemia
Treatment
Oral Anticoagulant
Antiplatelet Drug
Clinical Study ID
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with an acute ischemic stroke or TIA from 8 days and up to 360 days fromthe onset of symptoms
Age 20 or older
Patients with non-valvular atrial fibrillation (chronic or paroxysmal) who start orcontinue taking an oral anticoagulant
Patients who have one of the following atherothrombotic diseases
A past history of ischemic heart disease (myocardial infarction, anginapectoris, coronary artery bypass graft (CABG), percutaneous coronaryintervention (PCI)
A past history of peripheral artery disease (symptomatic peripheral arterialocclusive disease, lower extremity bypass surgery/angioplasty/stenting)
Carotid artery stenosis (symptomatic or asymptomatic (=>50% diameter), ahistory of carotid artery stenting (CAS) or carotid endarterectomy (CEA))
Intracranial artery stenosis (=>50% stenosis of the diameter of a majorintracranial artery: intracranial internal carotid artery, anterior cerebralartery (ACA)-A1 and A2, middle cerebral artery (MCA)-M1 and M2, posteriorcerebral artery (PCA)-P1 and P2, vertebral artery, and basilar artery; ahistory of intracranial stent placement or intracranial bypass surgery)
A past history of atherothrombotic brain infarction, lacunar infarction, orbranch 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
Exclusion Criteria:
History of myocardial infarction or acute coronary syndrome within the past 12months
Patients who underwent PCI with drug-eluting stents within the past 12 months or PCIwith 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 withinthe 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 chronichemodialysis.
Severe liver dysfunction (Grade B or C of the Child-Pugh classification)
Patients with severe disability requires constant nursing care, bedridden (modifiedRankin 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 weeksduring 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
Study Design
Study Description
Connect with a study center
Kobe City Medical Center General Hospital
Kobe, Hyogo 650-0047
JapanSite Not Available
National Cerebral and Cardiovascular Center
Suita, Osaka 565-8565
JapanSite Not Available
National Hospital Organization Osaka National Hospital
Osaka, 540-0006
JapanSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.