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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01855100

Acronym

BOX-DVT

Enrollment

131

Registered

2013-05-16

Start date

2013-07-31

Completion date

2014-12-31

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thrombosis

Keywords

Treatment of acute deep vein thrombosis, Prevention of recurrence, Oral anticoagulation, Real-life setting

Brief 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.

Interventions

DRUGRivaroxaban (Xarelto, BAY59-7939)

Starting dose (3 weeks): 15 mg BID, then 15 mg OD or 20 mg OD.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026