Clinical trial NCT01598051: Xarelto [SPAF-QOL] Post-marketing Surveillance in Japan
Official title: Treatment Satisfaction Under Rivaroxaban (ACTS/TSQM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-valvular Atrial Fibrillation (NVAF)
Keywords: Xarelto
SPAF
QOL
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2012-05-15
Enrollment: 741
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-valvular atrial fibrillation necessary for the treatment for prevention of ischemic stroke and systemic embolism

Brief summary: The objective of this study is to understand if Rivaroxaban can improve treatment satisfaction of Warfarin patients and assess the safety and effectiveness of Xarelto in real clinical practice.

A total of 725 patients are to be enrolled and followed for a 6 months.period. QOL survey will be conducted at month 0, 3, 6 using ACTS/TSQM.

This study is categorized as a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF.


Eligibility criteria: Inclusion Criteria:

* Patients treated by Warfarin for their atrial fibrillation for at least two months at the time of the study initiation.
* Rivaroxaban naïve patients
* Patients 20 years old or older.
* Patients who agree to sign the inform consent

Exclusion Criteria:

* Patients who are contraindicated by product label

Primary outcomes:
measure: Improvement of treatment satisfaction (Evaluated through ACTS and TSQM questionnaires)
timeFrame: Up to 6 months
measure: Incidence of ADRs and serious AEs (especially for hemorrhagic events, and liver disfunction with increase of liver-function-relating enzymes including bilirubin)
timeFrame: Up to 6 months
measure: Incidence of events of stroke
timeFrame: Up to 6 months
measure: Incidence of events of non-central nervous system embolism
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
measure: Treatment satisfaction scores at Month 3 and Month 6 by demographic and clinical characteristics
timeFrame: At Month 3 and Month 6
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Koretsune Y, Kumagai K, Uchiyama S, Yamashita T, Yasaka M, Watanabe-Fujinuma E, Banderas BF, Akiyama S, Okayama Y, Briere JB, Dickie G, Cano SJ. Patient-reported treatment satisfaction with rivaroxaban in Japanese non-valvular atrial fibrillation patients: an observational study. Curr Med Res Opin. 2018 Dec;34(12):2157-2164. doi: 10.1080/03007995.2018.1507315. Epub 2018 Aug 14.
citation: Watanabe-Fujinuma E, Banderas BF, Koretsune Y, Kumagai K, Uchiyama S, Yamashita T, Yasaka M, Akiyama S, Briere JB, Dickie G, Cano SJ. Psychometric validation of anti-clot treatment scale and treatment satisfaction questionnaire for medication version II in Japanese patients with atrial fibrillation. J Med Econ. 2019 Aug;22(8):798-805. doi: 10.1080/13696998.2019.1609003. Epub 2019 May 13.
citation: Gavrilov SG, Lebedev IS. Is the endovascular embolization of tributaries of the internal iliac veins essential in the treatment of isolated pelvic-perineal reflux? Curr Med Res Opin. 2019 Jan;35(1):27-31. doi: 10.1080/03007995.2018.1498781. Epub 2018 Jul 25.