Skip to main content
OpenTrials
Completed

NCT Number: NCT01855100

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Venous Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

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

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Scientific Affairs, LLC

Registry information

Official study title

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

Acronym: BOX-DVT

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 16, 2013
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.