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

This study has been completed.
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01619007
First received: May 29, 2012
Last updated: January 20, 2017
Last verified: January 2017
  Purpose

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 Intervention
Deep Vein Thrombosis Venous Thrombosis Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Standard of care

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Xarelto® for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]
  • Number of patients with symptomatic recurrent venous thromboembolic events [ Time Frame: 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 ]

Secondary Outcome Measures:
  • 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 ]
  • Number of patients with other symptomatic thromboembolic events [ Time Frame: 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 ]

Enrollment: 5145
Study Start Date: June 2012
Study Completion Date: July 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 )
Study First Received: May 29, 2012
Last Updated: January 20, 2017

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

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

ClinicalTrials.gov processed this record on September 20, 2017