Treatment of an Acute Deep Vein Thrombosis (DVT) With Either Rivaroxaban or Current Standard of Care Therapy (XALIA)

January 20, 2017 updated by: Bayer

Xarelto® for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE)

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 deep vein thrombosis (DVT).

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5145

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

In- and outpatients in sites participating in the study

Description

Inclusion Criteria:

  • Female and male patients
  • Patients >= 18 years
  • Patiebts with diagnosis of acute DVT and who have an indication for anticoagulation therapy for at least 12 weeks, who are willing to participate in this study and are available for follow-up

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the local product information.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Patients who will be treated for an acute deep vein thrombosis (DVT) with rivaroxaban
Group 2
Drug: Standard of care
Patients who will be treated for an acute deep vein thrombosis (DVT) with current standard of care comprising e.g. of initial treatment with low-molecular weight heparin or fondaparinux, followed by oral Vitamin-K antagonist for at least 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major bleedings defined as overt bleeding associated with: A fall in hemoglobin of ≥2 g/dL; or a transfusion of ≥2 units of packed red blood cells or whole blood; or occurrence at a critical site
Time Frame: after approximately 2 years or 30 days after stop of therapy
after approximately 2 years or 30 days after stop of therapy
Number of patients with symptomatic recurrent venous thromboembolic events
Time Frame: after approximately 2 years or 30 days after stop of therapy
after approximately 2 years or 30 days after stop of therapy
All cause mortality
Time Frame: after approximately 2 years or 30 days after stop of therapy
after approximately 2 years or 30 days after stop of therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety variables will be summarized using descriptive statistics based on adverse cardiac events collection
Time Frame: after approximately 2 years or 30 days after stop of therapy
after approximately 2 years or 30 days after stop of therapy
Number of patients with other symptomatic thromboembolic events
Time Frame: after approximately 2 years or 30 days after stop of therapy
after approximately 2 years or 30 days after stop of therapy
Treatment satisfaction (patient reported outcomes)
Time Frame: after approximately 2 years or 30 days after stop of therapy
after approximately 2 years or 30 days after stop of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

May 29, 2012

First Submitted That Met QC Criteria

June 12, 2012

First Posted (ESTIMATE)

June 14, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15915 (Saint Louis University Institutional Review Board)
  • XA1102 (OTHER: Company Internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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