None listed
Conditions
Interventions
Drug : Paticipants will be randomly assigned to either anticoagulation monotherapy group or combination therapy group. Participants assigned to the anticoagulation monotherapy group wil receive apixab
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. = 19 years old 2. Presence of AF with CHA2DS2-VASc score = 2 3. Patients with stable CAD – a history of percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) before 6 months (chronic coronary syndrome) or 12 months (acute coronary syndrome); anatomically confirmed CAD on coronary angiography or computed tomography scan 4. Presence of an excessive ischemic risk i. A history of myocardial infarction (MI) ii. Complex PCI iii. Untreated lesion with >50% stenosis at major epicardial vessel after coronary revascularization iv. Untreated multivessel CAD (>50% stenosis of >1 major epicardial vessel or left main stem) v. Peripheral artery disease vi. Cerebrovascular disease
Exclusion criteria
Exclusion criteria: 1. >85 years old. 2. Patients who received PCI or CABG within 6 months. 3. Patients with a history of acute coronary syndrome within 12 months. 4. Patients who require anticoagulation with warfarin due to a mechanical prosthetic valve, or = moderate mitral stenosis. 5. Patients with a comorbidity requiring anticoagulation other than AF. 6. Patients who is not able to receive apixaban or clopidogrel due to previous adverse reaction. 7. Patients who have coagulopathy or have a history of recurrent bleeding. 8. Intracranial or gastrointestinal bleeding within 3 months. 9. Gastrointestinal tumor requiring treatment. 10. Patients who are pregnant or those who report potential pregnancy. 11. Life expectancy < 1 year due to malignancy. 12. Refuse or enable to understand the written informed consent. 13. Patiens who are not able to discontinue a drug related to CYP3A4 inhibition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a composite of all-cause death, MI, stroke, systemic embolism, and major or clinically relevant non-major (CRNM) bleeding as defined by International Society on Thrombosis and Hemostasis (ISTH) criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemorrhagic stroke;Any coronary revascularization - CABG ((Coronary Artery Bypass Graft));Acute limb ischemia;Any limb revascularization or amputation - Endovascular revascularization ;Any intracranial revascularization - Endovascular revascularization ;A composite of cardiovascular death or MI;A composite of cardiovascular death, MI, acute limb ischemia, or ischemic stroke;A composite of cardiovascular death, acute limb ischemic, or any limb revascularization or amputation;A composite of cardiovascular death, ischemic stroke, or any intracranial revascularization;Each components of NACE - MI;Each components of NACE - stroke;Each components of NACE -systemic embolism;Each components of NACE - ISTH major bleeding;Each components of NACE - ISTH CRNM bleeding;Any coronary revascularization - PCI (Percutaneous Coronary Intervention);Any limb revascularization or amputation - Surgical revascularization;Any limb revascularization or amputation - Amputation;Any intracranial revascularization - Surgical revascularization;Composite bleeding event: a composite of ISTH major or CRNM bleeding;Major adverse cardiac event (MACE): a composite of cardiovascular death, MI, or any coronary revascularization;Key ischemic event: a composite of cardiovascular death, MI, ischemic stroke, or systemic embolism Secondary endpoint:;Each components of NACE – all-cause death;Cardiovascular death;Non-cardiovascular death;Ischemic stroke | — |
Countries
Korea, Republic of
Contacts
Public ContactJung-Sun kim
Yonsei University
Outcome results
None listed