Special Drug Use Surveillance of LIXIANA Tablet - Long-term use in patients with non-valvular atrial fibrillation -

Conditions

Prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation.

Giuseppe Boriani, Paulus Kirchhof, José Souza, Jan Steffel, Yukihiro Koretsune et al. (11 authors)

European Journal of Preventive Cardiology2025-10-18

Edoxaban treatment in routine clinical practice is highly concordant with the 2020 European Society of Cardiology atrial fibrillation guidelines: results from the noninterventional Global ETNA-AF programme

Doralisa Morrone, Leon Dinshaw, José Souza, Cathy Chen, Paulus Kirchhof et al. (11 authors)

European Heart Journal Open2025-03-01

10.1093/ehjopen/oeaf004

Two‐Year Follow‐Up of Patients With Atrial Fibrillation Receiving Edoxaban in Routine Clinical Practice: Results From the Global ETNA‐AF Program

Raffaele De Caterina, Martin Unverdorben, Cathy Chen, Eue‐Keun Choi, Yukihiro Koretsune et al. (11 authors)

Clinical Cardiology2025-02-273 citations

10.1002/clc.70091

Impact of body weight and body mass index on clinical outcomes of edoxaban therapy in atrial fibrillation patients included in the ETNA-AF-Global registry

Giuseppe Boriani, Júlio Souza, Jan Steffel, Yukihiro Koretsune, Tze‐Fan Chao et al. (10 authors)

European Heart Journal2024-10-01

10.1093/eurheartj/ehae666.604

The real-world effectiveness and safety of edoxaban treatment in 27,333 Global ETNA-AF programme patients with and without a history of heart failure

Jolanta M. Siller‐Matula, Martin Unverdorben, C C Wang, Yukihiro Koretsune, Ladislav Pecen et al. (9 authors)

European Heart Journal2022-10-011 citations

10.1093/eurheartj/ehac544.2700

Real-world effectiveness and safety of edoxaban in patients with and without a history of ischaemic stroke: results from the ETNA-AF programme

R De Caterina, Martin Unverdorben, B C Lee, Takeshi Yamashita, Wei‐Shiang Lin et al. (10 authors)

European Heart Journal2022-10-011 citations

10.1093/eurheartj/ehac544.2702

Two-year effectiveness and safety outcomes in 27,333 edoxaban-treated patients with and without a history of major bleeding from the Global ETNA-AF programme

Veronica Russo, C C Wang, Martin Unverdorben, Takeshi Yamashita, Ladislav Pecen et al. (9 authors)

European Heart Journal2022-10-01

10.1093/eurheartj/ehac544.2701

Safety and effectiveness of edoxaban in Japanese patients with nonvalvular atrial fibrillation: Final report of a two‐year postmarketing surveillance study (ETNA‐AF‐Japan)

Takeshi Yamashita, Yukihiro Koretsune, Tomoko Nagao, Kazuhito Shiosakai

Journal of Arrhythmia2021-02-2413 citations

10.1002/joa3.12520

Postmarketing surveillance on the clinical use of edoxaban in patients with nonvalvular atrial fibrillation (ETNA‐AF‐Japan): One‐year safety and effectiveness analyses

Takeshi Yamashita, Yukihiro Koretsune, Tomoko Nagao, Kazuhito Shiosakai

Journal of Arrhythmia2020-03-2414 citations

10.1002/joa3.12332

Postmarketing surveillance on clinical use of edoxaban in patients with nonvalvular atrial fibrillation (ETNA-AF-Japan): Three-month interim analysis results.

Yamashita T, Koretsune Y, Ishikawa M, Shiosakai K, Kogure S.

2018-12-268 citations

10.1002/joa3.12149

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet the following requirements when starting to receive LIXIANA (at the time of enrollment for [4]) will be considered for admission to the study: [1]Patients with NVAF who have just started to receive LIXIANA for the first time to prevent ischemic stroke and systemic embolism [2] Patients who are to start treatment with LIXIANA during the period of contract (as per the signed contract between the institution and the sponsor) and during the enrollment period [3]Patients who will be available for long-term follow-up [4]Patients who have given written informed consent to the study

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Safety (1)Occurrence of individual ADRs (2)Occurrence of serious AEs (3)Occurrence of ADRs by factors (4)Occurrence of bleeding AEs (5)Occurrence of bleeding AEs by factors Efficacy (1) Occurrence of endpoint events (death, stroke [excluding TIA], systemic embolism, and myocardial infarction) (2) Occurrence of endpoint events by factors Safety and efficacy in special populations ?Data from the study will be analyzed to investigate the safety and efficacy of LIXIANA in pediatric patients, elderly patients, pregnant/delivering women, patients with hepatic impairment and those with renal impairment.	—

Measure

Time frame

Safety (1)Occurrence of individual ADRs (2)Occurrence of serious AEs (3)Occurrence of ADRs by factors (4)Occurrence of bleeding AEs (5)Occurrence of bleeding AEs by factors Efficacy (1) Occurrence of endpoint events (death, stroke [excluding TIA], systemic embolism, and myocardial infarction) (2) Occurrence of endpoint events by factors Safety and efficacy in special populations ?Data from the study will be analyzed to investigate the safety and efficacy of LIXIANA in pediatric patients, elderly patients, pregnant/delivering women, patients with hepatic impairment and those with renal impairment.

—

Countries

Japan

Outcome results