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

• Status: Recruiting
• Trial end date: 2026-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cerebral and Cardiovascular Center; National Hospital Organization Osaka National Hospital
• Collaborators: Network for Clinical Stroke Trials; The BMS/Pfizer Japan Thrombosis Investigator Initiated Research Program
• Treatments: Anticoagulants; Platelet Aggregation Inhibitors; Warfarin

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