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CompletedNCT01855100BOX-DVTUpdated Jan 18, 2017

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

An observational study in Venous Thrombosis, sponsored by Bayer. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-18.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
131
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Venous Thrombosis

Keywords

  • Treatment of acute deep vein thrombosis
  • Prevention of recurrence
  • Oral anticoagulation
  • Real-life setting
03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 131 is below the median of 213 across 586 observational studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Ambulatory or hospitalized patients coming from the vascular diseases clinic of the participating hospitals

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

Exclusion Criteria:

  • Patients who do not fulfil the Belgian reimbursement criteria of deep vein thrombosis (DVT)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
131 participants (actual)

Groups and cohorts

  • Rivaroxaban

    Drug: Rivaroxaban (Xarelto, BAY59-7939)

Interventions

  • DrugRivaroxaban (Xarelto, BAY59-7939)

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

06

What researchers measure

Primary outcomes

  1. Number of patients with major bleedings

    Time frame: up to 1 year or 30 days after end of rivaroxaban

  2. Number of patients with symptomatic recurrent Venous Thrombus Embolism (VTE)

    Time frame: up to 1 year or 30 days after end of rivaroxaban

  3. All-cause mortality

    Time frame: up to 1 year or 30 days after end of rivaroxaban

  4. Adverse events

    Time frame: up to 1 year or 30 days after end of rivaroxaban

  5. Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS)

    Time frame: up to 1 year or 30 days after end of rivaroxaban

  6. Quantities of resource use consumption

    Time frame: up to 1 year or 30 days after end of rivaroxaban

07

Study locations

1 site
  • Many locations, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01855100
Lead sponsor
Bayer
Collaborators
Janssen Scientific Affairs, LLC
Responsible party
Sponsor
First posted
May 16, 2013
Start date
Jul 2013
Primary completion
Nov 2014
Completion
Dec 2014
Last update
Jan 18, 2017

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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