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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01855100
First received: May 14, 2013
Last updated: December 14, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention
Venous Thrombosis
Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Belgian Real Life Non-interventional Study (NIS) in Patients Treated With Xarelto® Following an Acute Deep Vein Thrombosis (DVT)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of patients with major bleedings [ Time Frame: up to 1 year or 30 days after end of rivaroxaban ] [ Designated as safety issue: Yes ]
  • Number of patients with symptomatic recurrent Venous Thrombus Embolism (VTE) [ Time Frame: up to 1 year or 30 days after end of rivaroxaban ] [ Designated as safety issue: Yes ]
  • All-cause mortality [ Time Frame: up to 1 year or 30 days after end of rivaroxaban ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: up to 1 year or 30 days after end of rivaroxaban ] [ Designated as safety issue: Yes ]
  • Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS) [ Time Frame: up to 1 year or 30 days after end of rivaroxaban ] [ Designated as safety issue: No ]
  • Quantities of resource use consumption [ Time Frame: up to 1 year or 30 days after end of rivaroxaban ] [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: July 2013
Study Completion Date: December 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rivaroxaban Drug: Rivaroxaban (Xarelto, BAY59-7939)
Starting dose (3 weeks): 15 mg BID, then 15 mg OD or 20 mg OD.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855100

Locations
Belgium
Many locations, Belgium
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01855100     History of Changes
Other Study ID Numbers: 16852  XA1314BE 
Study First Received: May 14, 2013
Last Updated: December 14, 2015
Health Authority: Belgium: Ethics Committee

Keywords provided by Bayer:
Treatment of acute deep vein thrombosis
Prevention of recurrence
Oral anticoagulation
Real-life setting

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants

ClinicalTrials.gov processed this record on September 27, 2016