Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2026-03-03 @ 10:02 PM
Study NCT ID:
NCT01800006
Status:
COMPLETED
Last Update Posted:
2017-06-21
First Post:
2013-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latinamerica and EMEA Region
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Algeria', 'Ecuador', 'Kuwait', 'Morocco', 'Peru', 'Qatar', 'Ukraine']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D004617', 'term': 'Embolism'}], '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'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}, '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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-20', 'studyFirstSubmitDate': '2013-02-25', 'studyFirstSubmitQcDate': '2013-02-25', 'lastUpdatePostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjudicated major bleeding events', 'timeFrame': 'after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later'}, {'measure': 'Safety variables will be summarized using descriptivestatistics based on adverse events collection', 'timeFrame': 'after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later'}, {'measure': 'All cause mortality', 'timeFrame': 'after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later'}], 'secondaryOutcomes': [{'measure': 'Adjudicated symptomatic thromboembolic events', 'timeFrame': 'after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later'}, {'measure': 'Non-major bleeding, collected as SAEs or non-serious AEs and defined as all bleeding events that do not fall in the category of major bleedings', 'timeFrame': 'after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later'}, {'measure': 'Treatment satisfaction', 'timeFrame': 'after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later'}, {'measure': 'Adverse events rates in the different AF risk factor categories', 'timeFrame': 'after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later'}, {'measure': 'Persistence with rivaroxaban treatment', 'timeFrame': 'after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later'}, {'measure': 'Reasons for switch of rivaroxaban treatment', 'timeFrame': 'after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later'}, {'measure': 'Reasons for interruption of rivaroxaban treatment', 'timeFrame': 'after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later'}, {'measure': 'Healthcare resource', 'timeFrame': 'after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later', 'description': 'Number of healthcare professional visits and hospitalizations due to anticoagulation therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Observation', 'Stroke', 'Embolism'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '38941511', 'type': 'DERIVED', 'citation': 'Kirchhof P, Haas S, Amarenco P, Turpie AGG, Bach M, Lambelet M, Hess S, Camm AJ. Causes of death in patients with atrial fibrillation anticoagulated with rivaroxaban: a pooled analysis of XANTUS. Europace. 2024 Jul 2;26(7):euae183. doi: 10.1093/europace/euae183.'}, {'pmid': '29976287', 'type': 'DERIVED', 'citation': 'Kirchhof P, Radaideh G, Kim YH, Lanas F, Haas S, Amarenco P, Turpie AGG, Bach M, Lambelet M, Hess S, Camm AJ; Global XANTUS program Investigators. Global Prospective Safety Analysis of Rivaroxaban. J Am Coll Cardiol. 2018 Jul 10;72(2):141-153. doi: 10.1016/j.jacc.2018.04.058.'}]}, 'descriptionModule': {'briefSummary': 'This international study is a prospective noninterventional observational cohort study of patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Patients will be followed up for 1 year or until 30 days after end of rivaroxaban therapy in case of therapy was discontinued earlier than 12 months. Serious adverse events will be followed up adequately. Laboratory values (e.g., Hb, HCT, haemoccult) should be documented for each point in time they were measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or noncentral nervous system systemic embolism.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism, and who consent to participate in the study.\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01800006', 'acronym': 'XANTUS-EL', 'briefTitle': 'Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latinamerica and EMEA Region', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'XANTUS-EL, Xarelto® on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Eastern EU, Middle East, Africa (EMEA) and Latin America (LATAM): A Non-interventional Study', 'orgStudyIdInfo': {'id': '16691'}, 'secondaryIdInfos': [{'id': 'XA1206', 'type': 'OTHER', 'domain': 'Company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Drug: Rivaroxaban (Xarelto, BAY59-7939)']}], 'interventions': [{'name': 'Rivaroxaban (Xarelto, BAY59-7939)', 'type': 'DRUG', 'description': 'Patients with non-valvular atrial fibrillation who are prescribed Rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Decision regarding dose and duration of treatment made at the discretion of the attending investigator.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'Argentina'}, {'city': 'Many Locations', 'country': 'Azerbaijan'}, {'city': 'Many Locations', 'country': 'Bahrain'}, {'city': 'Many Locations', 'country': 'Chile'}, {'city': 'Many Locations', 'country': 'Colombia'}, {'city': 'Many Locations', 'country': 'Egypt'}, {'city': 'Many Locations', 'country': 'Georgia'}, {'city': 'ManyLocations', 'country': 'Jordan'}, {'city': 'Many Locations', 'country': 'Kazakhstan'}, {'city': 'Many Locations', 'country': 'Kenya'}, {'city': 'ManyLocations', 'country': 'Lebanon'}, {'city': 'Many Locations', 'country': 'Mexico'}, {'city': 'Many Locations', 'country': 'Russia'}, {'city': 'ManyLocations', 'country': 'Saudi Arabia'}, {'city': 'Many Locations', 'country': 'United Arab Emirates'}, {'city': 'Many Locations', 'country': 'Uruguay'}, {'city': 'Many Locations', 'country': 'Venezuela'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}