Venous Thrombosis
Conditions
Keywords
SF36 questionnaire, Anti Clot Treatment Scale, Satisfaction, Quality of Life, Rivaroxaban, Prevention & control, Pulmonary embolism
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 issues in deep venous thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) is associated with an improvement of the treatment satisfaction after 3 months. The treatment satisfaction will be measured by the Anti Clot Treatment Scale (ACTS) score.
Interventions
DRUGRivaroxaban (Xarelto, BAY59-7939)
20 mg po once daily, which is also the recommended maximum dose. SmPC recommendations are to be followed for renal impairment
Sponsors
Janssen Research & Development, LLC
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score | After 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Change of ACTS score after 1 and 6 months of treatment | After 1 and 6 months |
| Continuation rate at 1, 3 and 6 months | After 1, 3 and 6 months |
| Change of SF36 score at 1, 3 and 6 months (health related quality of life determined by SF36 questionnaire) | After 1, 3 and 6 months |
| Physician's satisfaction at 1, 3 and 6 months assessed by a 5-point Likert scale response (very satisfied, satisfied, neutral, unsatisfied or very unsatisfied) | After 1, 3 and 6 months |
| Patient's compliance with VKA treatment at baseline and with Xarelto treatment at 1, 3 and 6 months assessed by the investigator as good (≥80%), average (50-80%) or poor (<50%) | After 1, 3 and 6 months |
Countries
France
Outcome results
None listed