Status:
COMPLETED
Satisfaction/Quality of Life With Rivaroxaban in DVT (Deep Venous Thrombosis) Indication
Lead Sponsor:
Bayer
Collaborating Sponsors:
Janssen Research & Development, LLC
Conditions:
Venous Thrombosis
Eligibility:
All Genders
18+ years
Brief Summary
National, multicenter, prospective, observational, non-interventional study. The objective is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated with VKA with i...
Eligibility Criteria
Inclusion
- Female or male subject ≥ 18 years of age,
- With a diagnosis of acute DVT treated with VKA with issues for at least the 4 previous weeks (issues are assessed on medical judgment)
- Who intends to start rivaroxaban for treatment of deep vein thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT
- With anticoagulation therapy planned for at least 3 months
Exclusion
- Contra indication to the use of Xarelto as described in the Summary of Product Characteristics (SmPC); key contra indications are:
- Hypersensitivity to the active substance or to any of the excipients listed in SmPC section 6.1.
- Lesion or condition at significant risk of major bleeding
- Concomitant treatment with any other anticoagulant agent
- Clinically significant active bleeding
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C
- Pregnancy and breast feeding
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT01805544
Start Date
May 1 2013
End Date
June 1 2015
Last Update
January 23 2017
Active Locations (1)
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1
Many Locations, France