UMIN ID: UMIN000017011
Registered date:12/04/2015
Special Drug Use Surveillance of LIXIANA Tablet - Long-term use in patients with non-valvular atrial fibrillation -
Basic Information
Recruitment status | Open public recruiting |
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Health condition(s) or Problem(s) studied | Prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation. |
Date of first enrollment | 2015/04/13 |
Target sample size | 10000 |
Countries of recruitment | Japan |
Study type | Observational |
Intervention(s) |
Outcome(s)
Primary Outcome | 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. |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | Not applicable |
Gender | Male and Female |
Include 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 |
Exclude criteria | None |
Related Information
Primary Sponsor | DAIICHI SANKYO COMPANY, LIMITED |
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Secondary Sponsor | |
Source(s) of Monetary Support | DAIICHI SANKYO COMPANY, LIMITED |
Secondary ID(s) |
Contact
public contact | |
Name | Shuichi Chikada |
Address | 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo 103-8426, Japan |
Telephone | +81-3-6225-1044 |
chikada.shuichi.ic@daiichisankyo.co.jp | |
Affiliation | DAIICHI SANKYO COMPANY, LIMITED Pharmacovigilance Department |
scientific contact | |
Name | Miyuki Arai |
Address | 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo 103-8426, Japan |
Telephone | +81-3-6225-1044 |
arai.miyuki.ue@daiichisankyo.co.jp | |
Affiliation | DAIICHI SANKYO COMPANY, LIMITED Pharmacovigilance Department |