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

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ClinicalTrials.gov Identifier: NCT01619007
Recruitment Status : Completed
First Posted : June 14, 2012
Last Update Posted : January 23, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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 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.


Condition or disease Intervention/treatment
Deep Vein Thrombosis Venous Thrombosis Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Standard of care

Study Design

Study Type : Observational
Actual Enrollment : 5145 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Xarelto® for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE)
Study Start Date : June 2012
Primary Completion Date : March 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. Number of patients with symptomatic recurrent venous thromboembolic events [ Time Frame: after approximately 2 years or 30 days after stop of therapy ]
  3. All cause mortality [ Time Frame: after approximately 2 years or 30 days after stop of therapy ]

Secondary Outcome Measures :
  1. 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 ]
  2. Number of patients with other symptomatic thromboembolic events [ Time Frame: after approximately 2 years or 30 days after stop of therapy ]
  3. Treatment satisfaction (patient reported outcomes) [ Time Frame: after approximately 2 years or 30 days after stop of therapy ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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.
Contacts and Locations

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): NCT01619007


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01619007     History of Changes
Other Study ID Numbers: 15915
XA1102 ( Other Identifier: Company Internal )
First Posted: June 14, 2012    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017

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

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