PRAEDO AF study

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2019
INTERVENTION: Arm Edoxaban monotherapy: Edoxaban will be orally administered at a dose of 60 mg if Body weight is over 60 kg and at a dose of 30 mg if Body weight is under 60 kg until end of study and if the creatinine clearance (CLcr) is 15‐50 mL/min . Arm Edoxaban co‐administered with Clopidgrel therapy: Edoxaban and Clopidgrel will be orally administered until end of study. Edoxaban administration : Edoxaban will be orally administered at a dose of 60 mg if Body weight is over 60 kg and at a dose of 30 mg if Body weight is under 60 kg until end of study and if the creatinine clearance (CLcr) is 15‐50 mL/min. Clopidgrel administration: Clopidgrel will be orally administered once a day after a meal at a dose of 75 mg. CONDITION: Non‐valvular atrial fibrillation PRIMARY OUTCOME: Major bleeding, Clinically relevant non‐major bleeding SECONDARY OUTCOME: 1) Composite endpoint of myocardial infarction, stent thrombosis, unstable angina pectoris requiring revascularizations (efficacy endpoints); 2) Composite endpoint of Stroke/systemic embolism and death from cardiovascular disease; 3) Myocardial infarction; 4) Stent thrombosis; 5) Unstable angina pectoris requiring revascularizations; 6) Stroke/systemic embolism; 7) minor bleeding; 8) Cardiovascular death ; 9) Non‐cardiovascular death INCLUSION CRITERIA: Patients with non‐valvular atrial fibrillation complicated with stable coronary artery disease who are 20 years or more at the obtaining of informed consent. CHADS2 score are 1 or more, and fulfil the criteria below and can provide written consent for participation in the present study will be eligible. 1) Patients who underwent percutaneous coronary intervention, including plain old balloon angioplasty. At least six months ago 2) Patients who have coronary stenosis requiring no percutaneous coronary intervention (50% or more stenosis) as indicated by coronary CT or coronary angiography 3) Patients who underwent coronary artery bypass graft CABG at least six months ago
Epistemonikos ID: 7085e08904dc9a0cb91f78110def0817c7d0722a
First added on: Aug 24, 2024