Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT01606995
Status:
COMPLETED
Last Update Posted:
2022-08-03
First Post:
2012-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Greece', 'Italy', 'Spain']}, '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': 6784}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2015-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-01', 'studyFirstSubmitDate': '2012-05-24', 'studyFirstSubmitQcDate': '2012-05-25', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjudicated major bleeding events', 'timeFrame': 'after 1 year or until 30 days after end of rivaroxaban therapy'}, {'measure': 'Safety variables will be summarized using descriptive statistics based on adverse events collection', 'timeFrame': 'after 1 year or until 30 days after end of rivaroxaban therapy'}], 'secondaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': 'after 1 year or until 30 days after end of rivaroxaban therapy'}, {'measure': 'Adjudicated symptomatic thromboembolic events', 'timeFrame': 'after 1 year or until 30 days after end of rivaroxaban therapy'}, {'measure': 'Persistence with rivaroxaban treatment: Reasons for any switch from or interruption of rivaroxaban treatment', 'timeFrame': 'after 1 year or until 30 days after end of rivaroxaban therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stroke', 'Embolism', 'Atrial fibrillation'], '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': '32079476', 'type': 'DERIVED', 'citation': 'Kirchhof P, Haas S, Amarenco P, Hess S, Lambelet M, van Eickels M, Turpie AGG, Camm AJ; XANTUS Investigators*. Impact of Modifiable Bleeding Risk Factors on Major Bleeding in Patients With Atrial Fibrillation Anticoagulated With Rivaroxaban. J Am Heart Assoc. 2020 Mar 3;9(5):e009530. doi: 10.1161/JAHA.118.009530. Epub 2020 Feb 21.'}, {'pmid': '30423165', 'type': 'DERIVED', 'citation': 'Amarenco P, Haas S, Hess S, Kirchhof P, Lambelet M, Bach M, Turpie AGG, Camm AJ. Outcomes associated with non-recommended dosing of rivaroxaban: results from the XANTUS study. Eur Heart J Cardiovasc Pharmacother. 2019 Apr 1;5(2):70-79. doi: 10.1093/ehjcvp/pvy041.'}, {'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.'}, {'pmid': '29016755', 'type': 'DERIVED', 'citation': 'Camm AJ, Turpie AGG, Hess S, Amarenco P, Lambelet M, Haas S, van Eickels M, Kirchhof P; XANTUS Investigators. Outcomes after catheter ablation and cardioversion in patients with non-valvular atrial fibrillation: results from the prospective, observational XANTUS study. Europace. 2018 Jun 1;20(6):e87-e95. doi: 10.1093/europace/eux127.'}, {'pmid': '26330425', 'type': 'DERIVED', 'citation': 'Camm AJ, Amarenco P, Haas S, Hess S, Kirchhof P, Kuhls S, van Eickels M, Turpie AG; XANTUS Investigators. XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation. Eur Heart J. 2016 Apr 7;37(14):1145-53. doi: 10.1093/eurheartj/ehv466. Epub 2015 Sep 1.'}, {'pmid': '25083135', 'type': 'DERIVED', 'citation': 'Camm AJ, Amarenco P, Haas S, Hess S, Kirchhof P, van Eickels M, Turpie AG. XANTUS: rationale and design of a noninterventional study of rivaroxaban for the prevention of stroke in patients with atrial fibrillation. Vasc Health Risk Manag. 2014 Jul 17;10:425-34. doi: 10.2147/VHRM.S63298. eCollection 2014.'}], 'seeAlsoLinks': [{'url': 'http://clinicaltrials.bayer.com/', 'label': 'Click here to find information for studies related to Bayer products. To find this study enter the NCT number or Bayer Study ID in the search field.'}]}, 'descriptionModule': {'briefSummary': 'This is an international observational study in patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS 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 (Central Nervous System) systemic embolism, and who consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT01606995', 'acronym': 'XANTUS', 'briefTitle': 'Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation', 'orgStudyIdInfo': {'id': '15914'}, 'secondaryIdInfos': [{'id': 'XA1101', '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': 'Multiple Locations', 'country': 'Austria'}, {'city': 'Multiple Locations', 'country': 'Belgium'}, {'city': 'Multiple Locations', 'country': 'Canada'}, {'city': 'Multiple Locations', 'country': 'Czechia'}, {'city': 'Multiple Locations', 'country': 'Denmark'}, {'city': 'Multiple Locations', 'country': 'France'}, {'city': 'Multiple Locations', 'country': 'Germany'}, {'city': 'Multiple Locations', 'country': 'Hungary'}, {'city': 'Multiple Locations', 'country': 'Ireland'}, {'city': 'Multiple Locations', 'country': 'Israel'}, {'city': 'Multiple Locations', 'country': 'Moldova'}, {'city': 'Multiple Locations', 'country': 'Netherlands'}, {'city': 'Multiple Locations', 'country': 'Norway'}, {'city': 'Multiple Locations', 'country': 'Poland'}, {'city': 'Multiple Locations', 'country': 'Portugal'}, {'city': 'Multiple Locations', 'country': 'Russia'}, {'city': 'Multiple Locations', 'country': 'Slovakia'}, {'city': 'Multiple Locations', 'country': 'Slovenia'}, {'city': 'Multiple Locations', 'country': 'Sweden'}, {'city': 'Multiple Locations', 'country': 'Ukraine'}, {'city': 'Multiple Locations', 'country': 'United Kingdom'}], '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'}}}}