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

Atrial Fibrillation Clinical Trial

— SAFARI  

Official title:

Satisfaction and Quality of Life in Patients With a Diagnosis of Non Valvular Atrial Fibrillation Who Take Rivaroxaban for Stroke Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805531
• Other study ID #: 16398
• Secondary ID: XA1213FR
• Status: Completed
• Phase: N/A
• First received: March 5, 2013
• Last updated: January 17, 2017
• Start date: April 2013
• Est. completion date: March 2015

Study information

• Verified date: January 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score		After 3 months
Secondary	Change of ACTS score after 1 and 6 months of treatment		After 1 and 6 months
Secondary	Continuation rate at 1, 3 and 6 months		After 1, 3 and 6 months
Secondary	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
Secondary	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
Secondary	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

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