check_circleStudy Completed

Venous thrombosis

Bayer Identifier:

16852

ClinicalTrials.gov Identifier:

NCT01855100

EudraCT Number:

Not Available

EU CT Number:

Not Available
Belgian real life non-interventional study (NIS) in patients treated with Xarelto following an acute deep vein thrombosis (DVT)

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Adult patients with a diagnosis of deep vein thrombosis (DVT) within the past 9 months, enabling at least 3 months of therapy
  • - Patients who do not fulfil the Belgian reimbursement criteria of deep vein thrombosis (DVT)

Trial summary

Enrollment Goal
131
Trial Dates
July 2013 - December 2014
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, Belgium

Primary Outcome

  • Number of patients with major bleedings
    date_rangeTime Frame:
    up to 1 year or 30 days after end of rivaroxaban
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of patients with symptomatic recurrent Venous Thrombus Embolism (VTE)
    date_rangeTime Frame:
    up to 1 year or 30 days after end of rivaroxaban
    enhanced_encryption
    Safety Issue:
    Yes
  • All-cause mortality
    date_rangeTime Frame:
    up to 1 year or 30 days after end of rivaroxaban
    enhanced_encryption
    Safety Issue:
    Yes
  • Adverse events
    date_rangeTime Frame:
    up to 1 year or 30 days after end of rivaroxaban
    enhanced_encryption
    Safety Issue:
    Yes
  • Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS)
    date_rangeTime Frame:
    up to 1 year or 30 days after end of rivaroxaban
    enhanced_encryption
    Safety Issue:
    No
  • Quantities of resource use consumption
    date_rangeTime Frame:
    up to 1 year or 30 days after end of rivaroxaban
    enhanced_encryption
    Safety Issue:
    No

Trial design

Belgian real life non-interventional study (NIS) in patients treated with Xarelto® following an acute deep vein thrombosis (DVT)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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