Satisfaction/Quality of Life With Rivaroxaban in SPAF (Stroke Prevention in Atrial Fibrillation) Indication (SAFARI)
This study is currently recruiting participants.
Verified April 2013 by Bayer
Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01805531
First received: March 5, 2013
Last updated: April 30, 2013
Last verified: April 2013
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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.
| Condition | Intervention |
|---|---|
|
Atrial Fibrillation |
Drug: Rivaroxaban (Xarelto, BAY59-7939) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Satisfaction and Quality of Life in Patients With a Diagnosis of Non Valvular Atrial Fibrillation Who Take Rivaroxaban for Stroke Prevention |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
Drug Information available for:
Rivaroxaban
U.S. FDA Resources
Further study details as provided by Bayer:
Primary Outcome Measures:
- Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score [ Time Frame: After 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change of ACTS score after 1 and 6 months of treatment [ Time Frame: After 1 and 6 months ] [ Designated as safety issue: No ]
- Continuation rate at 1, 3 and 6 months [ Time Frame: After 1, 3 and 6 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as 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") [ Time Frame: After 1, 3 and 6 months ] [ Designated as 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%) [ Time Frame: After 1, 3 and 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 550 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Rivaroxaban |
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients more than 18 years old, with a diagnosis of non-valvular atrial fibrillation, treated to prevent stroke or non-central nervous system systemic embolism, who switch from VKA to Xarelto due to issues with VKA
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01805531
Contacts
| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
Locations
| France | |
| Recruiting | |
| Many locations, France | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT01805531 History of Changes |
| Other Study ID Numbers: | 16398, XA1213FR |
| Study First Received: | March 5, 2013 |
| Last Updated: | April 30, 2013 |
| Health Authority: | France: none |
Keywords provided by Bayer:
|
SF36 questionnaire Anti Clot Treatment Scale Satisfaction |
Quality of Life Rivaroxaban Stroke prevention |
Additional relevant MeSH terms:
|
Atrial Fibrillation Stroke Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013