Patients with non-valvular Atrial Fibrillation and Ischemic Heart Disease Non-valvular atrial fibrillation
Conditions
Interventions
After eligibility criteria have been checked and written informed consent has been obtained by prior to PCI, patients who have been successfully implanted Xience will be randomized. Randomization will
Sponsors
Sakata Yasushi
Sotomi Yohei
Kozuma Ken
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Any PCI indication for native coronary lesions in non-valvular atrial fibrillation patients with CHADS2 score 1 or more, satisfying the following criteria: 1. Adjunctive oral anticoagulation treatment with a direct oral anticoagulant (DOAC) planned to continue after PCI 2. PCI indication for stable angina, unstable angina, and silent ischemia. 3. Subject is appropriate to be treated by PCI according to the local practice (operators judgment or heart team decision) 4. Patient is at least 20 years of age. 5. Signed Informed Consent by patient himself. 6. The patient understands and accepts clinical follow-up Angiographic: 1. Patients with angiographically significant stenosis in de novo, native, previously unstented lesions, which is in opinion of operator appropriate to be treated by PCI. 2. Significant stenosis was defined as 90% or greater stenosis of a major epicardial vessel or proof of functional ischemic test. 3. Patients with angiographically significant stenosis, which is in opinion of operator related to symptoms of angina.
Exclusion criteria
Exclusion criteria: Patients who conflict with any of the following will not be included in this study. 1.Pregnant and breastfeeding women 2. Patients expected not to comply with 1-month clopidogrel or prasugrel and DOAC 3. Patients requiring a planned staged PCI procedure more than two weeks (+14 days as occasion demands) after the index procedure 4. Patients presented with ST elevation myocardial infarction and non-ST elevation myocardial infarction 5. Active bleeding at the time of inclusion 6. Reference vessel diameter 5.75 mm 7. PCI for bypass graft vessel 8. Cardiogenic shock 9. Compliance with long-term DOAC alone therapy unlikely 10. Known hypersensitivity or contraindication to aspirin, clopidogrel, prasugrel, DOAC, cobalt chromium, everolimus, or a sensitivity to contrast media, which cannot be adequately avoided by pre-medication 11. PCI during the previous 6 months for a lesion other than the target lesion of the index procedure 12. Participation in another clinical trial (up to 12 months after index procedure) or already participated. 13. Patients with a life expectancy of < 1 year (12month) 14. Known severe renal insufficiency (e.g., Creatinine clearance <15 mL/min or subject on dialysis). 15. Patients inappropriate for the study participation in the opinion of the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The present trial has primary endpoints as follows: 1. Efficacy primary endpoint A composite of death or thromboembolic events (All-cause death, myocardial infarction, definite stent thrombosis, stroke, or systemic embolism) at 12month (365 days). 2. Safety primary endpoint Bleeding (ISTH major or clinically relevant nonmajor bleeding) at 12month (365 days). Non-inferiority test for the efficacy primary endpoint (a composite of death or thromboembolic events) will be performed. When the non-inferiority test of the efficacy primary endpoint is met, superiority test for safety primary endpoint will also be performed. If it is met, superiority test will be performed for the efficacy primary endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| In this study, the following secondary endpoints will be evaluated at 1, 12 and 18 months. 1) A composite of death, thromboembolic events or bleeding 2) Bleeding per BARC criteria BARC 2 to 5 BARC 3 to 5 All BARC 3) Bleeding per TIMI criteria Major Minor Minimal All individual components of primary endpoints including following clinical endpoints: 4) Death All-cause death Cardiovascular death Non-cardiaovascular death 5) Myocardial infarction according to the Third universal definition Q wave Myocardial Infarction Non-Q wave Myocardial Infarction All Myocardial Infarction Target vessel myocardial infarction Non-target vessel myocardial infarction 6) Stent Thrombosis per ARC definition Definite, Probable and Possible Acute, subacute, late, very late 7) Stroke Hemorrhagic stroke Ischemic stroke 8) Systemic embolization 9) Target lesion revascularization All TLR Clinically driven TLR Not clinically driven TLR 10) Target vessel revascularization All TVR Clinically driven TVR Not clinically driven TVR Non-target vessel revascularization All NTVR Clinically driven NTVR Not clinically driven NTVR 11) All coronary revascularization | — |
Contacts
Public ContactYohei Sotomi
The University of Osaka Hospital
Outcome results
None listed