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

TerminatedPhase 4

Sponsor: National Hospital Organization Osaka National Hospital

Conditions: Ischemic Stroke, Atrial Fibrillation, Atherothrombosis

Interventions: Oral Anticoagulant, Antiplatelet Drug

Countries: Japan

The Purpose of this open-label randomized controlled multicenter trial is to evaluate the efficacy and safety of mono-drug therapy with oral anticoagulant compared to combination therapy with antiplatelet drug, in ischemic stroke patients with non-valvular atrial fibrillation and atherothrombosis.

Eligibility overview

Sex: ALL

Age: 20 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 or older
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

   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 consent either directly or by a suitable surrogate

Exclusion Criteria:

1. 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 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

Locations (1)

Osaka, Osaka, Japan