An analysis on validity of distribution of biomarkers, exploration of correlation between biomarker outliers and adverse events under rivaroxaban in Japanese patients with non-valvular atrial fibrillation (CVI ARO 2 study)

An analysis on validity of distribution of biomarkers, exploration of correlation between biomarker outliers and adverse events under rivaroxaban in Japanese patients with non-valvular atrial fibrillation (CVI ARO 2 study) - R-mark (CVI ARO 2) study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000022721

Enrollment

400

Registered

2016-06-13

Start date

2016-06-01

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 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
Distribution of PT value (peak) by multiple reagents (Compare with the results of CVI ARO study 1)	—

Secondary

Measure	Time frame
(1) Bleeding (ISTH major bleeding, clinically relevant non-major bleeding, etc.) (2) Characteristics of HAS-BLED, CHADS2, and CHA2DS2VASc in patients with outlier of PT values and direct and indirect serum concentration. (3) Adverse events in patients with outlier of PT values and direct and indirect serum concentration. (4) Affecting factors for adverse events by outlier of PT values and direct and indirect serum concentration. (5) Reproducibility of PT values and direct and indirect serum concentration (6) All adverse events	—

Measure

Time frame

(1) Bleeding (ISTH major bleeding, clinically relevant non-major bleeding, etc.) (2) Characteristics of HAS-BLED, CHADS2, and CHA2DS2VASc in patients with outlier of PT values and direct and indirect serum concentration. (3) Adverse events in patients with outlier of PT values and direct and indirect serum concentration. (4) Affecting factors for adverse events by outlier of PT values and direct and indirect serum concentration. (5) Reproducibility of PT values and direct and indirect serum concentration (6) All adverse events

—

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