Special Drug Use Investigation of Xarelto for Venous Thromboembolism (VTE)

NCT02558465 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2540

Last updated 2022-11-01

No results posted yet for this study

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
  • Bayer

    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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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02558465 on ClinicalTrials.gov