A PK/PD study of oral FXa inhibitor Edoxaban Tosilate Hydrate in patients with nonvalvular atrial fibrillation (NVAF) who have developed acute heart failure.

未提供0 个研究点目标入组 30 人开始时间: 2019年5月20日最近更新: 2021年4月2日

适应症

试验速览

阶段: 不适用
状态: 已完成
入组人数: 30
主要终点: Ratio of trough value at the administration from day 1 to 7 to the concentration of Edoxaban plasma (trough value) at the time of final blood drawing

暂无简介。

•Patients who required hospitalization due to acute heart failure (including acute exacerbation of chronic heart failure)
•Patients who received a definitive diagnosis of NVAF
•Patients who are administered Edoxaban Tosilate Hydrate on obtaining informed consent or patients who will newly start administration of Edoxaban Tosilate Hydrate after obtaining informed consent
•Patients who is available for oral administration at registration
•Aged 20 years or older on obtaining informed consent

•Patients using oral anticoagulant other than Edoxaban Tosilate Hydrate at the time of admission
•Patients with a past medical history of hypersensitivity to Edoxaban Tosilate Hydrate
•Patients with acute bacterial endocarditis
•Patients with renal failure (creatinine clearance calculated by Cockcroft-Gault equation is less than 15 mL/min)
•Patients who is receiving Dual anti-platelet therapy (DAPT)
•Patients with cardiopulmonary arrest or cardiogenic shock
•Patients who had gastrointestinal bleeding or major bleeding (ISTH criteria) within 4 weeks of enrollment
•Patients who are unlikely to complete research, such as progressive malignant tumor merger
•Pregnant patients
•Patients who have been enrolled in this study in the past
•Participating or scheduled to participate in clinical studies with intervention
•Patients who have been judged inappropriate as the subjects of this study by the principle investigator and others

Ratio of trough value at the administration from day 1 to 7 to the concentration of Edoxaban plasma (trough value) at the time of final blood drawing

时间窗: from day 1 to 7

Ratio of trough value at the administration from day 1 to 7 to the concentration of Edoxaban plasma (trough value) at the time of final blood drawing

Transition of Edoxaban Tosilate Hydrate plasma concentration (trough value)

时间窗: from day 1 to the final blood drawing

Transition of Edoxaban Tosilate Hydrate plasma concentration (trough value) (from day 1 to the final blood drawing)

发起方

未提供