Special Drug Use Surveillance of LIXIANA Tablet- Long-term use in patients with non-valvular atrial fibrillation
Phase 4
- Conditions
- Prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation.
- Registration Number
- JPRN-UMIN000017011
- Lead Sponsor
- DAIICHI SANKYO COMPANY, LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open public recruiting
- Sex
- All
- Target Recruitment
- 10000
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
None
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety<br>(1)Occurrence of individual ADRs<br>(2)Occurrence of serious AEs<br>(3)Occurrence of ADRs by factors<br>(4)Occurrence of bleeding AEs<br>(5)Occurrence of bleeding AEs by factors<br><br>Efficacy<br>(1) Occurrence of endpoint events (death, stroke [excluding TIA], systemic embolism, and myocardial infarction)<br>(2) Occurrence of endpoint events by factors<br><br>Safety and efficacy in special populations<br>?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 Measures
Name Time Method