Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT03247569
Status:
COMPLETED
Last Update Posted:
2022-05-06
First Post:
2017-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (NVAF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552171', 'term': 'edoxaban'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-05', 'studyFirstSubmitDate': '2017-08-09', 'studyFirstSubmitQcDate': '2017-08-09', 'lastUpdatePostDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with real world safety events', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Number of participants with patient relevant outcomes', 'timeFrame': '2 years', 'description': 'Categories: Strokes (ischaemic and haemorrhagic), Systemic Embolic Events (SEE), Transient Ischemic Attack (TIA), Major Adverse Cardiovascular Events (MACE), Venous Thromboembolism (VTE), Acute Coronary Syndrome (ACS), Hospitalisations related to cardiovascular (CV) condition'}, {'measure': 'Average duration of exposure to edoxaban', 'timeFrame': 'within 2 years'}, {'measure': 'Number of participants compliant with edoxaban therapy', 'timeFrame': '2 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-valvular Atrial Fibrillation', 'Real World Evidence', 'Observational Safety'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '24251359', 'type': 'BACKGROUND', 'citation': 'Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.'}, {'pmid': '40014354', 'type': 'DERIVED', 'citation': 'De Caterina R, Unverdorben M, Chen C, Choi EK, Koretsune Y, Morrone D, Pecen L, Bramlage P, Wang CC, Yamashita T, Kirchhof P. Two-Year Follow-Up of Patients With Atrial Fibrillation Receiving Edoxaban in Routine Clinical Practice: Results From the Global ETNA-AF Program. Clin Cardiol. 2025 Feb;48(3):e70091. doi: 10.1002/clc.70091.'}]}, 'descriptionModule': {'briefSummary': 'In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the NVAF indication, Daiichi-Sankyo Thailand proposed this non-interventional study (NIS) to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other adverse events) of edoxaban use in non-preselected patients with NVAF.', 'detailedDescription': 'Edoxaban was recently approved by The Thai Food and Drug Administration (Thai FDA) (date: 2nd December 2016) for the prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults.\n\nIn order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the NVAF indication, Daiichi-Sankyo Thailand proposed this non-interventional study (NIS) to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other adverse events) of edoxaban use in non-preselected patients with NVAF.\n\nReal world evidence data of routine clinical practice use of edoxaban up to 2 years will be collected and evaluated in approximately 300 patients, treated by specialized as well as non-specialized physicians in hospital centres.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Primary strategy is to include only patients with NVAF who are to be treated with edoxaban according to Package Information (Summary of Product Characteristics (SmPC)). To ensure that the physician's prescribing behaviour will not be influenced, patients may only be included after the treating physician has made the clinical decision to prescribe edoxaban.\n\nPatients must have provided written informed consent for participation in the study (ICF) and should not participate simultaneously in any interventional study.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is a NVAF-patient whose physician has made the clinical decision to prescribe edoxaban therapy according to Package Information\n* Has provided written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Is participating in an interventional study'}, 'identificationModule': {'nctId': 'NCT03247569', 'briefTitle': 'Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (NVAF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'Non-interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Thailand)', 'orgStudyIdInfo': {'id': 'DU176b-C-A4011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Edoxaban', 'description': 'Patients treated with Edoxaban', 'interventionNames': ['Drug: Edoxaban']}], 'interventions': [{'name': 'Edoxaban', 'type': 'DRUG', 'otherNames': ['Lixiana'], 'description': 'Edoxaban according to Package Information (Summary of Product Characteristics (SmPC)).', 'armGroupLabels': ['Edoxaban']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40002', 'city': 'Khon Kaen', 'state': 'Muang District', 'country': 'Thailand', 'facility': 'Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Bangkok Heart Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Bhumibol Adulyadej Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Bangkok Hospital Chiang Mai', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Maharaj Nakorn Chiang Mai Hospital', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'city': 'Pathum Thani', 'country': 'Thailand', 'facility': 'Thammasat University Hospital', 'geoPoint': {'lat': 14.01346, 'lon': 100.53049}}], 'overallOfficials': [{'name': 'Late Phase Operations Lead, Global Medical Affairs', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company'}, {'name': 'Study Project Manager', 'role': 'STUDY_CHAIR', 'affiliation': 'Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/daiichi-sankyo/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/', 'accessCriteria': "Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}