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OpenTrials
Completed

NCT Number: NCT01805531

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

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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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Behavior Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

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.

Primary outcomes

  1. Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score

    Time frame: After 3 months

Secondary outcomes

  1. Change of ACTS score after 1 and 6 months of treatment

    Time frame: After 1 and 6 months

  2. Continuation rate at 1, 3 and 6 months

    Time frame: After 1, 3 and 6 months

  3. Change of SF36 score at 1, 3 and 6 months (health related quality of life determined by SF36 questionnaire)

    Time frame: After 1, 3 and 6 months

  4. 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")

    Time frame: After 1, 3 and 6 months

  5. 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%)

    Time frame: After 1, 3 and 6 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Scientific Affairs, LLC

Registry information

Official study title

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

Acronym: SAFARI

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 6, 2013
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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