Clinical trial NCT01805531: Satisfaction/Quality of Life With Rivaroxaban in SPAF (Stroke Prevention in Atrial Fibrillation) Indication
Official title: Satisfaction and Quality of Life in Patients With a Diagnosis of Non Valvular Atrial Fibrillation Who Take Rivaroxaban for Stroke Prevention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: SF36 questionnaire
Anti Clot Treatment Scale
Satisfaction
Quality of Life
Rivaroxaban
Stroke prevention
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2013-03-06
Enrollment: 411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients more than 18 years old, with a diagnosis of non-valvular atrial fibrillation, treated to prevent stroke or non-central nervous system systemic embolism, who switch from VKA to Xarelto due to issues with VKA

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score
timeFrame: After 3 months
Secondary outcomes:
measure: Change of ACTS score after 1 and 6 months of treatment
timeFrame: After 1 and 6 months
measure: Continuation rate at 1, 3 and 6 months
timeFrame: After 1, 3 and 6 months
measure: 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
measure: 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
measure: 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
Other outcomes:
Locations:
city: Many locations
country: France
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: