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

Study Overview

• Status: Completed
• Conditions: Venous Thrombosis
• Intervention / Treatment: Drug: Rivaroxaban (Xarelto, BAY59-7939)

• Study Type: Observational
• Enrollment (Actual): 131

Contacts and Locations

Study Locations

• Belgium
  • Many locations, Belgium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rivaroxaban	Drug: Rivaroxaban (Xarelto, BAY59-7939); Starting dose (3 weeks): 15 mg BID, then 15 mg OD or 20 mg OD.

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Janssen Scientific Affairs, LLC

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): November 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: May 14, 2013
• First Submitted That Met QC Criteria: May 14, 2013
• First Posted (ESTIMATE): May 16, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 18, 2017
• Last Update Submitted That Met QC Criteria: January 17, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Oral anticoagulation; Real-life setting; Treatment of acute deep vein thrombosis; Prevention of recurrence
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: 16852; XA1314BE (OTHER: Company internal)