Satisfaction/Quality of Life With Rivaroxaban in SPAF (Stroke Prevention in Atrial Fibrillation) Indication

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939)

• Registration Number: NCT01805531
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-05
• Study First Submitted QC: 2013-03-05
• Study First Posted: 2013-03-06
• Study Start: 2013-04
• Primary Completion: 2015-01
• Study Completion: 2015-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 411

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Rivaroxaban (Xarelto, BAY59-7939)	-

Primary Outcome Measures

Name	Time	Method
Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score	After 3 months

Secondary Outcome Measures

Name	Time	Method
Continuation rate at 1, 3 and 6 months	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%)	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")	After 1, 3 and 6 months
Change of ACTS score after 1 and 6 months of treatment	After 1 and 6 months
Change of SF36 score at 1, 3 and 6 months (health related quality of life determined by SF36 questionnaire)	After 1, 3 and 6 months