Optimizing Antithrombotic Care in Patients With AtriaL fibrillatiON and Coronary stEnt (OAC-ALONE) Study (OAC-ALONE)
Atrial Fibrillation, Coronary Artery Disease
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Percutaneous coronary intervention, Stent, Anticoagulant therapy, Antiplatelet therapy, Warfarin, NOAC, Aspirin, Clopidogrel
Eligibility Criteria
Inclusion Criteria:
- Patients with a documented history of AF who underwent PCI with stenting >12 months before enrollment.
- Patients who are treated with OAC (warfarin or NOAC) and an antiplatelet drug (aspirin or clopidogrel), but not with other antiplatelet drugs including ticlopidine, prasugrel, ticagrelor, and cilostazol.
- In patients treated with warfarin, the INR value at enrollment should be => 1.6, and agreement on dose adjustment of warfarin with the target INR range of 2.0-3.0 for those <70 years and 1.6-2.6 for those =>70 years, which is recommended in the Japanese guidelines, is necessary before enrollment.
- Patients 20 years or older.
- Patients with written informed consent.
Exclusion Criteria:
- Patients who underwent PCI including balloon angioplasty alone within the past 12 months.
- Patients in whom OAC is scheduled to be discontinued during the follow-up period.
- Patients with a past history of ST.
- Patients with a planned coronary revascularization.
- Patients with a planned cardiovascular or non-cardiovascular surgery.
- Patients with expectation of survival less than one year.
Sites / Locations
- Kyoto University Graduate School of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
OAC alone
OAC plus single APT
OAC includes warfarin or NOAC. The dose of warfarin should be adjusted with the target international normalized ratio (INR) range of 2.0-3.0 for those <70 years and 1.6-2.6 for those =>70 years, which is recommended in the Japanese guidelines. NOAC includes dabigatran 150mg or 110mg twice daily, rivaroxaban 15mg daily with the reduced dose of 10mg daily, apixaban 5mg twice daily with the reduced dose of 2.5mg twice daily, and edoxaban 60mg daily with the reduced dose of 30mg daily.
OAC includes warfarin or NOAC. The dose of warfarin should be adjusted with the target INR range of 2.0-3.0 for those <70 years and 1.6-2.6 for those =>70 years, which is recommended in the Japanese guidelines. NOAC includes dabigatran 150mg or 110mg twice daily, rivaroxaban 15mg daily with the reduced dose of 10mg daily, apixaban 5mg twice daily with the reduced dose of 2.5mg twice daily, and edoxaban 60mg daily with the reduced dose of 30mg daily. Single APT includes aspirin or clopidogrel. The dose of aspirin is 81-324mg/day and the dose of clopidogrel is 75mg/day.