OPTIMAl antiplatelet therapy in combination with direct oral anticoagulants in patients with non-valvular Atrial Fibrillation undergoing percutaneous coronary intervention with everolimus-eluting stent: a multicenter prospective randomized controlled trial - OPTIMA-AF trial

Sakata Yasushi0 个研究点目标入组 1,090 人开始时间: 2019年10月1日最近更新: 2023年10月17日

适应症

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•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.

•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
•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 <2.25 - >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

发起方

Sakata Yasushi