Xarelto [SPAF-QOL] Post-marketing Surveillance in Japan

Non-valvular Atrial Fibrillation (NVAF) Clinical Trial

Official title:

Treatment Satisfaction Under Rivaroxaban (ACTS/TSQM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598051
• Other study ID #: 16296
• Status: Completed
• Start date: May 31, 2012
• Est. completion date: March 31, 2017

Study information

• Verified date: May 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 741
• Est. completion date: March 31, 2017
• Est. primary completion date: June 9, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-valvular Atrial Fibrillation (NVAF)

Intervention

Drug:
• Rivaroxaban (Xarelto_ BAY59-7939)
Patients treated with Xarelto under practical manner for SPAF.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment satisfaction scores at Month 3 and Month 6 by demographic and clinical characteristics		At Month 3 and Month 6
Primary	Improvement of treatment satisfaction (Evaluated through ACTS and TSQM questionnaires)		Up to 6 months
Primary	Incidence of ADRs and serious AEs (especially for hemorrhagic events, and liver disfunction with increase of liver-function-relating enzymes including bilirubin)		Up to 6 months
Primary	Incidence of events of stroke		Up to 6 months
Primary	Incidence of events of non-central nervous system embolism		Up to 6 months

External Links

•   Click here to find results for studies related to Bayer products.