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Treatment of Venous Thromboembolism (VTE) With Either Rivaroxaban or Current Standard of Care Therapy

NCT02210819 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1987

Last updated 2019-08-29

No results posted yet for this study

Summary

Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute venous thoromboembolism (VTE).

The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute VTE in routine clinical practice.

Conditions

  • Deep Vein Thrombosis (DVT)
  • Pulmonary Embolism (PE)

Interventions

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Cohort participants are classified as "rivaroxaban" patient, if the patient receives initial rivaroxaban VTE treatment. Dosing according to daily clinical routine

DRUG

Recommended VTE pharmacological treatments according to international guidelines

Cohort participants are classified as "Standard of care" patients, if the patient receives recommended VTE pharmacological treatments according to international guidelines, e.g. unfractionated heparin, LMWH, fondaparinux, VKA, if these are also approved pharmacological treatments for VTE in the respective country. Dosing according to daily clinical routine.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-27
Primary Completion
2016-11-03
Completion
2017-01-20

Countries

  • Algeria
  • Egypt
  • Indonesia
  • Jordan
  • Kazakhstan
  • Kenya
  • Kuwait
  • Lebanon
  • Malaysia
  • Mexico
  • Morocco
  • Philippines
  • Qatar
  • Russia
  • Saudi Arabia
  • Singapore
  • South Korea
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Arab Emirates

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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 NCT02210819 on ClinicalTrials.gov