Trial Condition(s):

Venous thrombosis

Satisfaction/Quality of Life with Rivaroxaban in DVT (deep venous thrombosis) indication (SATORI)

Bayer Identifier:

16409

ClinicalTrials.gov Identifier:

NCT01805544

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
113
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many locations, France

Status
Completed
 

Trial Design