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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

411 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rivaroxaban

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

20 mg po once daily, which is also the recommended maximum dose. In subjects with moderate creatinine clearance (30-49 ml/min), the dose 15 mg once daily is recommended.

Interventions

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Rivaroxaban (Xarelto, BAY59-7939)

20 mg po once daily, which is also the recommended maximum dose. In subjects with moderate creatinine clearance (30-49 ml/min), the dose 15 mg once daily is recommended.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No