NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedPrevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Date of first enrollment2015/04/13
Target sample size10000
Countries of recruitmentJapan
Study typeObservational
Intervention(s)

Outcome(s)

Primary OutcomeSafety (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.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteriaPatients 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 criteriaNone

Related Information

Contact

public contact
Name Shuichi Chikada
Address 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo 103-8426, Japan
Telephone +81-3-6225-1044
E-mail 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
E-mail arai.miyuki.ue@daiichisankyo.co.jp
Affiliation DAIICHI SANKYO COMPANY, LIMITED Pharmacovigilance Department