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

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ClinicalTrials.gov Identifier: NCT02210819
Recruitment Status : Completed
First Posted : August 7, 2014
Last Update Posted : March 20, 2018
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Brief 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.


Condition or disease Intervention/treatment
Deep Vein Thrombosis (DVT) and / or Pulmonary Embolism (PE) Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Recommended VTE pharmacological treatments according to international guidelines

Study Type : Observational
Actual Enrollment : 1987 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: XALIA LEA- Xarelto for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE) in Latin America, EMEA and Asia
Actual Study Start Date : June 27, 2014
Actual Primary Completion Date : November 3, 2016
Actual Study Completion Date : January 20, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

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.




Primary Outcome Measures :
  1. 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

  2. Number of patients with symptomatic recurrent venous thromboembolic events [ Time Frame: Up to 2 years ]
  3. All cause mortality [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. 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.

  2. Number of patients with other symptomatic thromboembolic events [ Time Frame: Up to 2 years ]
  3. Treatment satisfaction (patient reported outcomes) [ Time Frame: Up to 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In- and outpatients in sites participating in the study.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210819


  Show 21 Study Locations
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02210819     History of Changes
Other Study ID Numbers: 17237
XA1402 ( Other Identifier: Company internal )
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Keywords provided by Bayer:
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

Additional relevant MeSH terms:
Embolism and Thrombosis
Thrombosis
Thromboembolism
Embolism
Venous Thromboembolism
Pulmonary Embolism
Venous Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants