Trial Condition(s):
Brain Ischemia
Xarelto [SPAF] post-marketing surveillance in Japan
Bayer Identifier:
15798
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF.
The objective of this study is to assess safety and effectiveness of Xarelto using in real clinical practice.
A total of 10,000 patients are to be enrolled and assessed in 2 years standard observational period. An annual follow-up survey will be conducted for 5 years at the longest after standard observational period.
Inclusion Criteria
- Patients with non-valvular atrial fibrillation (NVAF) for whom the decision to be treated with Xarelto was made - Patients without experience of using Xarelto prior to the study
Exclusion Criteria
- Patients who are contraindicated based on the product label
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Special drug use investigation of Xarelto [SPAF]
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Incidence of ADRs and serious AEs (especially for hemorrhagic events, and liver disfunction with increase of liver-function-relating enzymes including bilirubin)Timeframe: Up to 2 years
- Incidence of events of strokeTimeframe: Up to 5 years
- Incidence of events of non-central nervous system embolismTimeframe: Up to 5 years
Secondary Outcome
- Determination of patient’s demography to affect the safety and efficacy of Xarelto using standard observational survey and follow-up surveyTimeframe: Baseline
- Determination of patient’s medical history to affect the safety and efficacy of Xarelto using standard observational survey and follow-up surveyTimeframe: Baseline
- Determination of patient’s background to affect the safety and efficacy of Xarelto using standard observational survey and follow-up surveyTimeframe: Baseline
Additional Information
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