Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT01598051
Status:
COMPLETED
Last Update Posted:
2019-05-30
First Post:
2012-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Xarelto [SPAF-QOL] Post-marketing Surveillance in Japan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 741}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-28', 'studyFirstSubmitDate': '2012-04-20', 'studyFirstSubmitQcDate': '2012-05-11', 'lastUpdatePostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Treatment satisfaction scores at Month 3 and Month 6 by demographic and clinical characteristics', 'timeFrame': 'At Month 3 and Month 6'}], 'primaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Xarelto', 'SPAF', 'QOL'], 'conditions': ['Non-valvular Atrial Fibrillation (NVAF)']}, 'referencesModule': {'references': [{'pmid': '30067119', 'type': 'BACKGROUND', '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.'}, {'pmid': '30995146', 'type': 'DERIVED', '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.'}, {'pmid': '29985674', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nA 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with non-valvular atrial fibrillation necessary for the treatment for prevention of ischemic stroke and systemic embolism', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated by Warfarin for their atrial fibrillation for at least two months at the time of the study initiation.\n* Rivaroxaban naïve patients\n* Patients 20 years old or older.\n* Patients who agree to sign the inform consent\n\nExclusion Criteria:\n\n* Patients who are contraindicated by product label'}, 'identificationModule': {'nctId': 'NCT01598051', 'briefTitle': 'Xarelto [SPAF-QOL] Post-marketing Surveillance in Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Treatment Satisfaction Under Rivaroxaban (ACTS/TSQM)', 'orgStudyIdInfo': {'id': '16296'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patients treated with Xarelto under practical manner for SPAF.', 'interventionNames': ['Drug: Rivaroxaban (Xarelto_ BAY59-7939)']}], 'interventions': [{'name': 'Rivaroxaban (Xarelto_ BAY59-7939)', 'type': 'DRUG', 'description': 'Patients treated with Xarelto under practical manner for SPAF.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Janssen Scientific Affairs, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}