Trial Condition(s):
Venous thrombosis
Satisfaction/Quality of Life with Rivaroxaban in DVT (deep venous thrombosis) indication (SATORI)
Bayer Identifier:
16409
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many locations, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Satisfaction and Quality of Life in patients with a diagnosis of DVT (deep venous thrombosis) who take Rivaroxaban
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline scoreTimeframe: After 3 months
Secondary Outcome
- Change of ACTS score after 1 and 6 months of treatmentTimeframe: After 1 and 6 months
- Continuation rate at 1, 3 and 6 monthsTimeframe: 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)Timeframe: 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”)Timeframe: 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%)Timeframe: After 1, 3 and 6 months
Additional Information
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