check_circleStudy Completed
Venous thrombosis
Bayer Identifier:
16852
ClinicalTrials.gov Identifier:
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
BothAge
18 - N/ATrial summary
Enrollment Goal
131Trial Dates
July 2013 - December 2014Phase
N/ACould I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations, Belgium |
Primary Outcome
- Number of patients with major bleedingsdate_rangeTime Frame:up to 1 year or 30 days after end of rivaroxabanenhanced_encryptionYesSafety Issue:
- Number of patients with symptomatic recurrent Venous Thrombus Embolism (VTE)date_rangeTime Frame:up to 1 year or 30 days after end of rivaroxabanenhanced_encryptionYesSafety Issue:
- All-cause mortalitydate_rangeTime Frame:up to 1 year or 30 days after end of rivaroxabanenhanced_encryptionYesSafety Issue:
- Adverse eventsdate_rangeTime Frame:up to 1 year or 30 days after end of rivaroxabanenhanced_encryptionYesSafety Issue:
- Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS)date_rangeTime Frame:up to 1 year or 30 days after end of rivaroxabanenhanced_encryptionNoSafety Issue:
- Quantities of resource use consumptiondate_rangeTime Frame:up to 1 year or 30 days after end of rivaroxabanenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A