An analysis on distribution and inter-relationships of biomarkers under edoxaban in Japanese patients with non-valvular atrial fibrillation

An analysis on distribution and inter-relationships of biomarkers under edoxaban in Japanese patients with non-valvular atrial fibrillation - CVI ARO 7 study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000028383

Enrollment

100

Registered

2017-07-26

Start date

2017-06-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with non-valvular atrial fibrillation who are taking edoxaban for prevention of ischemic stroke

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with non-valvular atrial fibrillation (including paroxysmal atrial fibrillation) who are taking edoxaban. Eligible conditions are follows: 1) Taking edoxaban for more than 2 weeks. 2) Age >= 20 years 3) Given informed consent.

Exclusion criteria

Exclusion criteria: (1) Receiving dual anti-platelet therapy (2) Inadequate dosage of edoxaban at registration (3) Edoxaban hypersensitivity (4) Patients who are bleeding (5) Patients with acute bacterial endocarditis (6) Renal dysfunction (creatinine clearance <30 mL/min) (7) River dysfunction with clotting disorder (8) Patients who had admitted with cardiovascular disease (stroke, myocardial infarction, PCI, and heart failure) or bleeding requiring hospitalization within 1 month before the registration (9) Patients who did not give written informed consents for this study (10) Patients who are judged by the researchers as inadequate for this study

Design outcomes

Primary

Measure	Time frame
1) Distribution of serum concentration of edoxaban and its 90% interval 2) PT and APTT under edoxaban and its 90% interval	—

Secondary

Measure	Time frame
All adverse events during the observation period	—

Countries

Japan

Contacts

Public ContactKazumi Matsuda

Cardiovascular Institute Academic Research Organization (CVI ARO) Head office

matsuda@cvi.or.jp+81-3-3408-2151

Outcome results