Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT02864758
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2016-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
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': 'D000069552', 'term': 'Rivaroxaban'}, {'id': 'C008208', 'term': 'acarboxyprothrombin'}, {'id': 'D000069604', 'term': 'Dabigatran'}], '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'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99999}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-05', 'studyFirstSubmitDate': '2016-08-09', 'studyFirstSubmitQcDate': '2016-08-09', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stroke and systemic embolism (Effectiveness outcome)', 'timeFrame': 'One year and Two Year', 'description': 'Hospitalization with ischemic or undefined stroke or other systemic arterial embolism or surgical procedure for systemic arterial embolism To compare one year and two year risk between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran.'}, {'measure': 'Major Bleeding', 'timeFrame': 'One year and Two Year', 'description': 'Hospitalization with haemorrhagic stroke, other critical organ or site bleeding (intraspinal, intraocular,retroperitoneal, intraarticular or pericardial, or intramuscular), Other bleeding with a transfusion during hospital stay, or resulting in death.\n\nTo compare one year and two year risk between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran.'}, {'measure': 'Death', 'timeFrame': 'One year and Two Year', 'description': 'All-cause death. To compare one year and two year risk between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran.'}], 'secondaryOutcomes': [{'measure': 'Pattern of use (Exposure, Adherence, Discontinuation, Switch)', 'timeFrame': 'Up to two years', 'description': 'To describe the drug exposure to rivaroxaban, dabigatran, and VKA for SPAF in new users and pattern of use'}, {'measure': 'A composite of stroke and SE, major bleeding and death, clinically relevant bleeding and acute coronary syndrome', 'timeFrame': 'One year and Two Year', 'description': 'To compare one year and two year risk between new users of anticoagulant for SPAF during drug exposure: rivaroxaban vs VKA, and rivaroxaban vs dabigatran'}, {'measure': 'Cumulative incidence and incidence rate of stroke and SE, major bleeding, clinically relevant bleeding, death, composite criteria, and acute coronary syndrome as well as according individual diagnose of each of these outcomes', 'timeFrame': 'Up to two years', 'description': 'During drug exposure for rivaroxaban, dabigatran, and VKA'}, {'measure': 'Cumulative incidence of Stroke and SE, major bleeding, clinically relevant bleeding, death, composite criteria, and acute coronary syndrome as well as according individual diagnose of each of these outcomes', 'timeFrame': 'Up to two years', 'description': 'Post-anticoagulant exposure for rivaroxaban, dabigatran, and VKA (i.e. after anticoagulant discontinuation)'}, {'measure': 'Healthcare resources utilisation', 'timeFrame': 'Up to two years', 'description': 'Healthcare resources use will be described from reimbursed claims and hospitalisation information Healthcare resources cost will be estimated using the French HAS methodological guide for economic evaluations (2011)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '31390972', 'type': 'BACKGROUND', 'citation': 'Blin P, Fauchier L, Dureau-Pournin C, Sacher F, Dallongeville J, Bernard MA, Lassalle R, Droz-Perroteau C, Moore N. Effectiveness and Safety of Rivaroxaban 15 or 20 mg Versus Vitamin K Antagonists in Nonvalvular Atrial Fibrillation. Stroke. 2019 Sep;50(9):2469-2476. doi: 10.1161/STROKEAHA.119.025824. Epub 2019 Aug 8.'}, {'pmid': '31638652', 'type': 'DERIVED', 'citation': 'Fauchier L, Blin P, Sacher F, Dureau-Pournin C, Bernard MA, Lassalle R, Droz-Perroteau C, Dallongeville J, Moore N. Reduced dose of rivaroxaban and dabigatran vs. vitamin K antagonists in very elderly patients with atrial fibrillation in a nationwide cohort study. Europace. 2020 Feb 1;22(2):205-215. doi: 10.1093/europace/euz285.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/', 'label': 'Click here to find results for studies related to Bayer products.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the one-year and two-year risk of each of the following individual outcomes: Stroke and systemic embolism (SE), major bleeding and death between new users of anticoagulant for Stroke prevention in atrial fibrillation (SPAF) during drug exposure: rivaroxaban versus Vitamin K antagonists (VKA), and rivaroxaban versus dabigatran', 'detailedDescription': 'Main objective: To compare the one-year and two-year risk of each of the following individual outcomes: Stroke and systemic embolism (SE), major bleeding and death between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran.\n\nSecondary objectives:\n\n* To describe the drug exposure to rivaroxaban, dabigatran, and VKA for SPAF in new users, as well as and pattern of use;\n* To compare the one-year and two-year risk of the following individual outcomes: a composite of stroke and SE, major bleeding and death, clinically relevant bleeding (CRB) and acute coronary syndrome (ACS) between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran;\n* To estimate the cumulative incidence and the incidence rate of each individual main and secondary outcome (stroke and SE, major bleeding, CRB, death, composite criteria, and ACS), as well as according to individual diagnose of each of these outcomes, during drug exposure for rivaroxaban, dabigatran, and VKA;\n* To estimate the cumulative incidence of each individual main and secondary outcome (stroke and SE, major bleeding, CRB, death, composite criteria, and ACS), as well as according individual diagnose of each of these outcomes during post-anticoagulant exposure for rivaroxaban, dabigatran, and VKA (i.e. after anticoagulant discontinuation);\n* To assess outcome risk factors, including (but not limited to), gender, age, stroke and bleeding risk scores (CHA2DS2-VASc and HAS-BLED), low or high dosage at index date for DOAC, drug predisposing to bleeding during drug exposure and significant baseline characteristics;\n* To describe and compare healthcare resources utilisation related to SPAF during rivaroxaban, dabigatran, and VKA exposure, including outcomes, and their related costs from the societal perspective and from the French healthcare insurance perspective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All subjects with a first reimbursed dispensation of rivaroxaban (15 or 20 mg), dabigatran (110 or 150 mg) or vitamin k antagonists in 2013 or 2014 diagnosed with Atrial Fibrillation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Definite non-valvular atrial fibrillation:\n* A first reimbursed dispensation of rivaroxaban, dabigatran, or VKA in 2013 or 2014, and\n* No previous DOAC (rivaroxaban, dabigatran, apixaban) or VKA dispensation during the previous three years,\n* Definite AF information in the database Probable non-valvular atrial fibrillation:-\n* A first reimbursed dispensation of rivaroxaban, dabigatran, or VKA in 2013 or 2014, and\n* No previous DOAC (rivaroxaban, dabigatran, apixaban) or VKA dispensation during the previous three years,\n* Probable AF information in the database (using the development of an AF disease score, see variables definition below),\n\nExclusion Criteria:\n\n* Patients with Rheumatic valve disease\n* Patients with valve replacement\n* Patients treated with anticoagulants for venous\n* thromboemboslim or prevention of venous\n* thromboembolism after orthopedic surgery'}, 'identificationModule': {'nctId': 'NCT02864758', 'acronym': 'BROTHER', 'briefTitle': 'Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in Daily Clinical Practice - A French Cohort Within the Nationwide Claims and Hospital Database', 'orgStudyIdInfo': {'id': '18656'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Adult patients with nonvalvular atrial fibrillation (NVAF) treated with rivaroxaban', 'interventionNames': ['Drug: Rivaroxaban (Xarelto, BAY59-7939)']}, {'label': 'Group 2', 'description': 'Adult patients with nonvalvular atrial fibrillation (NVAF) treated with vitamin k anatognists', 'interventionNames': ['Drug: Vitamin K antagonists']}, {'label': 'Group 3', 'description': 'Adult patients with nonvalvular atrial fibrillation (NVAF) treated with dabigatran', 'interventionNames': ['Drug: dabigatran (Pradaxa)']}], 'interventions': [{'name': 'Rivaroxaban (Xarelto, BAY59-7939)', 'type': 'DRUG', 'description': 'Tablets, 20mg once daily', 'armGroupLabels': ['Group 1']}, {'name': 'Vitamin K antagonists', 'type': 'DRUG', 'description': 'Tablets, dose is based on International Normalized Ratio', 'armGroupLabels': ['Group 2']}, {'name': 'dabigatran (Pradaxa)', 'type': 'DRUG', 'description': 'Tablets, 150 mg twice daily', 'armGroupLabels': ['Group 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'France', 'facility': 'Many Locations'}], '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'}}}}