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

NCT01598051 | Completed

• 1 other identifier: 16296
• Study Type: observational
• Target: 741
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-valvular Atrial Fibrillation (NVAF)

Keywords

Xarelto; SPAF; QOL

Outcome Measures

Primary Outcomes (4)

• Improvement of treatment satisfaction (Evaluated through ACTS and TSQM questionnaires)

  Up to 6 months

• 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

• Incidence of events of stroke

  Up to 6 months

• Incidence of events of non-central nervous system embolism

  Up to 6 months

Other Outcomes (1)

• Treatment satisfaction scores at Month 3 and Month 6 by demographic and clinical characteristics

  At Month 3 and Month 6

Study Arms (1)

Group 1

Patients treated with Xarelto under practical manner for SPAF.

Drug: Rivaroxaban (Xarelto_ BAY59-7939)

Interventions

Rivaroxaban (Xarelto_ BAY59-7939) DRUG

Patients treated with Xarelto under practical manner for SPAF.

Group 1

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients who are contraindicated by product label

Sponsors & Collaborators

• Bayer: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Unknown Facility

Multiple Locations, Japan

Location

Related Publications (3)

• 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.

  PMID: 30067119 BACKGROUND

• 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.

  PMID: 30995146 DERIVED

• 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.

  PMID: 29985674 DERIVED

MeSH Terms

Interventions

Rivaroxaban

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: May 15, 2012
• Study Start: May 31, 2012
• Primary Completion: June 9, 2016
• Study Completion: March 31, 2017
• Last Updated: May 30, 2019

Record last verified: 2019-05

Locations

JP (1)