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

August 27, 2019 updated by: Bayer

XALIA LEA- Xarelto for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE) in Latin America, EMEA and Asia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1987

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 or male patients, who are at >=18 years
  • Diagnosis of acute DVT and/or PE, objectively confirmed
  • Indication for anticoagulation therapy for at least 12 weeks
  • Willing to participate in this study and 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
Rivaroxaban
Patients who will be treated for an acute venous thromboembolism (VTE) with rivaroxaban.
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
Standard of care
Patients who will be treated for an acute venous thromboembolism (VTE) with current standard of care.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of major bleedings defined as overt bleeding
Time Frame: Up to 2 years
Major bleedings defined as overt bleeding are 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
Up to 2 years
Number of patients with symptomatic recurrent venous thromboembolic events
Time Frame: Up to 2 years
Up to 2 years
All cause mortality
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse cardiovascular events
Time Frame: Up to 2 years
Number of cardiovascular events will be used for descriptive statistics to summarize safety variables.
Up to 2 years
Number of patients with other symptomatic thromboembolic events
Time Frame: Up to 2 years
Up to 2 years
Treatment satisfaction (patient reported outcomes)
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

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

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

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 (Actual)

June 27, 2014

Primary Completion (Actual)

November 3, 2016

Study Completion (Actual)

January 20, 2017

Study Registration Dates

First Submitted

May 20, 2014

First Submitted That Met QC Criteria

August 5, 2014

First Posted (Estimate)

August 7, 2014

Study Record Updates

Last Update Posted (Actual)

August 29, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17237 (City of Hope Medical Center)
  • XA1402 (Other Identifier: 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.

Clinical Trials on Deep Vein Thrombosis (DVT)

Clinical Trials on Rivaroxaban (Xarelto, BAY59-7939)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe