Special Drug Use Investigation of Xarelto for Venous Thromboembolism (VTE)
NCT02558465 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2540
Last updated 2022-11-01
Summary
The objective of this investigation is to assess safety and effectiveness of Xarelto under practice routine use in VTE secondary prevention after acute DVT, focusing on hemorrhagic-related AEs, recurrent venous thromboembolism (PE/DVT), all-cause mortality. This study is a company sponsored, one- arm prospective cohort study with patients to whom Rivaroxaban treatment for VTE (PE/DVT) has been chosen. The study includes a standard observation period (1 year) and an extension survey period (2 years, at the longest).
Conditions
- Venous Thromboembolism
Interventions
- DRUG
-
Rivaroxaban (Xarelto, BAY59-7939)
Treatment parameters following the summary of product characteristics and the physician's decision
Sponsors & Collaborators
-
Janssen Research & Development, LLC
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Bayer Study Director · Bayer
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-11-13
- Primary Completion
- 2021-04-01
- Completion
- 2021-05-31
Countries
- Japan
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