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| Name | Class |
|---|---|
| Janssen Scientific Affairs, LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Patients treated with Xarelto under practical manner for SPAF. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto_ BAY59-7939) | Drug | Patients treated with Xarelto under practical manner for SPAF. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment satisfaction scores at Month 3 and Month 6 by demographic and clinical characteristics | At Month 3 and Month 6 |
Inclusion Criteria:
Exclusion Criteria:
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Patients with non-valvular atrial fibrillation necessary for the treatment for prevention of ischemic stroke and systemic embolism
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30067119 | Background | 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. | |
| 30995146 |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| Derived |
| 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. |
| 29985674 | 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. |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |