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Xarelto [SPAF] Post-marketing Surveillance in Japan

NCT01582737 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 11310

Last updated 2023-07-24

No results posted yet for this study

Summary

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.

Conditions

  • Brain Ischemia

Interventions

DRUG

Rivaroxaban(Xarelto, BAY59-7939)

Patients treated with Xarelto under practical manner

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-30
Primary Completion
2019-03-31
Completion
2020-01-17

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 NCT01582737 on ClinicalTrials.gov