An analysis on distribution and inter-relationships of biomarkers under rivaroxaban in Japanese patients with non-valvular atrial fibrillation (CVI ARO 1 study)

An analysis on distribution and inter-relationships of biomarkers under rivaroxaban in Japanese patients with non-valvular atrial fibrillation (CVI ARO 1 study) - An analysis on distribution and inter-relationships of biomarkers under rivaroxaban in Japanese patients with non-valvular atrial fibrillation (CVI ARO 1 study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000016424

Enrollment

100

Registered

2015-02-02

Start date

2015-01-26

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 rivaroxaban for primary 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 rivaroxaban for primary prevention of ischemic stroke (both of naive and experienced)

Exclusion criteria

Exclusion criteria: (1) Receiving dual anti-platelet therapy (2) Inadequate dosage of rivaroxaban at PT measurement (3) Rivaroxaban hypersensitivity (4) River dysfunction with clotting disorder (5) Moderate and high river dysfunction (Child-Pugh classification B or C) (6) Renal dysfunction (creatinine clearance <30 mL/min) (7) Women who are pregnant or may be pregnant (8) Patients taking HIV protease inhibitor (ritonavir, atazanavir, indinavir, etc) (9)Patients taking azole antimycotic agent (itraconazole, voriconazole, ketoconazole, etc., excluding fluconazole) (10) Patients taking drugs containing cobicistat (11) Patients taking drugs with CYP3A4 or strong P-glycoprotein derivant (rifampicin, phenytoin, carbamazepine, phenobarbital, Saint John's wort-containing food, etc.) (12) Patients with acute bacterial endocarditis (13) Patients who did not give written informed consents for this study (14) Patients who are judged by the researchers as inadequate for this study

Design outcomes

Primary

Measure	Time frame
PT values with multiple reagents and anti-Xa activity under rivaroxaban, and serum concentration of rivaroxaban	—

Secondary

Measure	Time frame
adverse events including ischemic stroke	—

Countries

Japan

Contacts

Public ContactKazumi Matsuda

The Cardio Vascular Institute Academic Research Organization (CVI ARO) Head office

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

Outcome results