check_circleStudy Completed

Atrial fibrillation

Bayer Identifier:

16398

ClinicalTrials.gov Identifier:

NCT01805531

EudraCT Number:

Not Available

EU CT Number:

Not Available
Satisfaction/Quality of Life with Rivaroxaban in SPAF (stroke prevention in atrial fibrillation) indication

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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
411
Trial Dates
April 2013 - March 2015
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, France

Primary Outcome

  • Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score
    date_rangeTime Frame:
    After 3 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change of ACTS score after 1 and 6 months of treatment
    date_rangeTime Frame:
    After 1 and 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Continuation rate at 1, 3 and 6 months
    date_rangeTime Frame:
    After 1, 3 and 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Change of SF36 score at 1, 3 and 6 months (health related quality of life determined by SF36 questionnaire)
    date_rangeTime Frame:
    After 1, 3 and 6 months
    enhanced_encryption
    Safety Issue:
    No
  • 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”)
    date_rangeTime Frame:
    After 1, 3 and 6 months
    enhanced_encryption
    Safety Issue:
    No
  • 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%)
    date_rangeTime Frame:
    After 1, 3 and 6 months
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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