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

Venous Thrombosis Clinical Trial

— BOX-DVT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855100
• Other study ID #: 16852
• Secondary ID: XA1314BE
• Status: Completed
• Phase: N/A
• First received: May 14, 2013
• Last updated: January 17, 2017
• Start date: July 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
Starting dose (3 weeks): 15 mg BID, then 15 mg OD or 20 mg OD.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with major bleedings		up to 1 year or 30 days after end of rivaroxaban
Primary	Number of patients with symptomatic recurrent Venous Thrombus Embolism (VTE)		up to 1 year or 30 days after end of rivaroxaban
Primary	All-cause mortality		up to 1 year or 30 days after end of rivaroxaban
Primary	Adverse events		up to 1 year or 30 days after end of rivaroxaban
Primary	Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS)		up to 1 year or 30 days after end of rivaroxaban
Primary	Quantities of resource use consumption		up to 1 year or 30 days after end of rivaroxaban

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