one

Phase 4

• Conditions: onvalvular atrial fibrillation which has developed acute cardiac heart failure; acute cardiac insufficiency, nonvalvular atrial fibrillation

• Registration Number: JPRN-jRCTs031190006
• Lead Sponsor: abeta Takeru

Brief Summary

This study provided the first evidence that the plasma concentration and PD of edoxaban were constant at steady-state during hospitalization in patients with NVAF and acute heart failure. The plasma concentration and PD profiles of edoxaban observed in this study were generally consistent with the previous data from studies involving NVAF patients without acute heart failure. These results provide valuable information to use edoxaban safely in patients with NVAF who have developed acute heart failure.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-05
• Study Completion: 2020-02-28
• Results First Posted: 2021-03-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Patients who required hospitalization due to acute heart failure (including acute exacerbation of chronic heart failure)
2. Patients who received a definitive diagnosis of NVAF
3. 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
4. Patients who is available for oral administration at registration
5. Aged 20 years or older on obtaining informed consent

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. 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<br>2. Transition of Edoxaban Tosilate Hydrate plasma concentration (trough value) (from day 1 to the final blood drawing)

Secondary Outcome Measures

Name	Time	Method
1. Pharmacokinetics<br>Pharmacokinetic parameters (Cmax, AUCtau, Tmax) of plasma Edoxaban Tosilate Hydrate on day 0 of administration and at the last blood drawing<br>2. Pharmacodynamics<br>Changes in the following pharmacodynamic biomarkers at the blood drawing<br>1) Prothrombin fragment 1 + 2 (Fl + 2)<br>2) D-dimer<br>3) PT