Patients with atrial fibrillation undergoing percutaneous coronary intervention
Conditions
Interventions
1 months duration of clopidgrel (1 months triple therapy with aspirin, clopidpgrel, and apixaban)
6 months duration of clopidgrel (6 months triple therapy with aspirin, clopidpgrel, and apixaban)
Sponsors
Cardiovascular Division, Faculty of Medicine, University of Tsukuba
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with non-valvular atrial fibrillation 2. Patients with coronary artery disease who underwent drug-eluting stent implantation 3. Patients with concomitant administration of apixaban and dual antiplatelet treatment (aspirin and clopidogrel) 4. Patients with 20 years and over 5. Patients with CHADS2-Vasc score of 1 and over 6. Patients who were obtained written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients who cannot tolerate antiplatelets and anticoagulants 2. Patients after mechanical valve replacement 3. Patients in whom a stent has been placed in the left main trunk 4. Patients in whom stents have been placed in a bifurcated lesion by the two stent technique 5. Patients complicated with decompensated heart failure or cardiogenic shock 6. Patients complicated with advanced chronic kidney disease (creatinine clearance <15 ml/min) 7. Patients with a past history of intracranial hemorrhage 8. Patients with a past history of stent thrombosis 9. Patients for whom surgery (cardiac and noncardiac surgery) is scheduled 10. Patients for whom pulmonary vein isolation is scheduled 11. Patients with active hemorrhage 12. Patients with active malignant tumor 13. Patients with pregnancy 14. Patients who are not expected to live 1 year or longer 15. Patients deemed to be inappropriate as the subjects of this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any bleeding events: TIMI(Major/Minor), BARC, or blood transfusion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Composite events of all-cause death, myocardial infarction, stroke, or systemic embolization 2. Net clinical benefit of all-cause death, myocardial infarction, stroke, or systemic embolization, and bleeding complications (BARC type 3 or higher) 3. Individual endpoints (1)All-cause death (2)Cardiovascular death (3)Non-cardiovascular death (4)Myocardial infarction (5)Unstable angina (6)Stroke (7)Systemic embolization (8)Stent thrombosis (9)Coronary revascularization (10)Surgery (11)CABG (12)Heart failure (13)Discontinuation of anticoagulant or antiplatelet treatment | — |
Countries
Japan
Contacts
Public ContactTomoya Hoshi
University of Tsukuba, Faculty of Medicine Cardiovascular Division
Outcome results
None listed