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Belgian Real Life Non-interventional Study (NIS) in Patients Treated With Xarelto Following an Acute Deep Vein Thrombosis (DVT) (BOX-DVT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01855100
First Posted: May 16, 2013
Last Update Posted: January 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Bayer
May 14, 2013
May 16, 2013
January 18, 2017
July 2013
November 2014   (Final data collection date for primary outcome measure)
  • Number of patients with major bleedings [ Time Frame: up to 1 year or 30 days after end of rivaroxaban ]
  • Number of patients with symptomatic recurrent Venous Thrombus Embolism (VTE) [ Time Frame: up to 1 year or 30 days after end of rivaroxaban ]
  • All-cause mortality [ Time Frame: up to 1 year or 30 days after end of rivaroxaban ]
  • Adverse events [ Time Frame: up to 1 year or 30 days after end of rivaroxaban ]
  • Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS) [ Time Frame: up to 1 year or 30 days after end of rivaroxaban ]
  • Quantities of resource use consumption [ Time Frame: up to 1 year or 30 days after end of rivaroxaban ]
Real-life medical resource use consumption based on medical examination and patient diary cards [ Time Frame: Up to 1 year ]
Complete list of historical versions of study NCT01855100 on ClinicalTrials.gov Archive Site
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Belgian Real Life Non-interventional Study (NIS) in Patients Treated With Xarelto Following an Acute Deep Vein Thrombosis (DVT)
Belgian Real Life Non-interventional Study (NIS) in Patients Treated With Xarelto® Following an Acute Deep Vein Thrombosis (DVT)
The objective of this NIS is to assess in a real-life setting, usage patterns and associated outcomes in the management (healthcare resource utilisation and associated costs) of patients with acute deep vein thrombosis treated with Xarelto, in accordance with the terms of the European marketing authorization and the Belgian reimbursement criteria.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Ambulatory or hospitalized patients coming from the vascular diseases clinic of the participating hospitals
Venous Thrombosis
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Starting dose (3 weeks): 15 mg BID, then 15 mg OD or 20 mg OD.
Rivaroxaban
Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
December 2014
November 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients with a diagnosis of deep vein thrombosis (DVT) within the past 9 months, enabling at least 3 months of therapy

Exclusion Criteria:

  • Patients who do not fulfil the Belgian reimbursement criteria of deep vein thrombosis (DVT)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01855100
16852
XA1314BE ( Other Identifier: Company internal )
No
Not Provided
Not Provided
Bayer
Bayer
Janssen Scientific Affairs, LLC
Study Director: Bayer Study Director Bayer
Bayer
January 2017