Trial Condition(s):
Atrial Fibrillation
Satisfaction/Quality of Life with Rivaroxaban in SPAF (stroke prevention in atrial fibrillation) indication (SAFARI)
Bayer Identifier:
16398
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 for stroke prevention in non valvular atrial fibrillation 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 and male subjects ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation - Who are treated with Vitamin K antagonists (VKA) with issues for at least the 4 previous weeks (issues are assessed on medical judgment) - Who start treatment with rivaroxaban to prevent stroke or non-CNS (central nervous system) systemic embolism - With anticoagulation therapy planned for at least 6 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 non valvular atrial fibrillation who take Rivaroxaban for Stroke Prevention
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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