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JRCT ID: jRCTs031190006

Registered date:05/04/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Nonvalvular atrial fibrillation which has developed acute cardiac heart failure
• Date of first enrollment: 20/05/2019
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Treatment with Edoxaban Tosilate Hydrate will be selected as antithrombotic treatment.

Outcome(s)

Primary Outcome

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

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Nabeta Takeru
• Source(s) of Monetary Support: Daiichi Sankyo Company, Limited