Trial Condition(s):
Venous thrombosis
Belgian real life non-interventional study (NIS) in patients treated with Xarelto following an acute deep vein thrombosis (DVT) (BOX-DVT)
Bayer Identifier:
16852
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many locations, Belgium | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Number of patients with major bleedingsTimeframe: up to 1 year or 30 days after end of rivaroxaban
- Number of patients with symptomatic recurrent Venous Thrombus Embolism (VTE)Timeframe: up to 1 year or 30 days after end of rivaroxaban
- All-cause mortalityTimeframe: up to 1 year or 30 days after end of rivaroxaban
- Adverse eventsTimeframe: up to 1 year or 30 days after end of rivaroxaban
- Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS)Timeframe: up to 1 year or 30 days after end of rivaroxaban
- Quantities of resource use consumptionTimeframe: up to 1 year or 30 days after end of rivaroxaban
Additional Information
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