Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-29 @ 8:09 PM
Study NCT ID:
NCT04509193
Status:
COMPLETED
Last Update Posted:
2022-06-15
First Post:
2020-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Using Electronic Health Information to Learn About Rivaroxaban Compared to Warfarin in Participants With Non-valvular Atrial Fibrillation (NVAF) and Diabetes
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': 'D014859', 'term': 'Warfarin'}], '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': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'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': 116049}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-13', 'studyFirstSubmitDate': '2020-08-10', 'studyFirstSubmitQcDate': '2020-08-10', 'lastUpdatePostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of stroke or systemic embolism', 'timeFrame': 'Up to 8 years'}, {'measure': 'Any major or clinically-relevant nonmajor bleed resulting in hospitalization', 'timeFrame': 'Up to 8 years'}], 'secondaryOutcomes': [{'measure': 'Ischemic stroke', 'timeFrame': 'Up to 8 years'}, {'measure': 'Systemic embolism', 'timeFrame': 'Up to 8 years'}, {'measure': 'Need for revascularization or major amputation of the lower limb', 'timeFrame': 'Up to 8 years'}, {'measure': 'Intracranial hemorrhage', 'timeFrame': 'Up to 8 years'}, {'measure': 'Critical organ bleeding per ISTH categories', 'timeFrame': 'Up to 8 years', 'description': 'The categories for critical organ bleeding as per ISTH definition are: intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome.'}, {'measure': 'Any extracranial bleeding', 'timeFrame': 'Up to 8 years'}, {'measure': 'Any hospitalization due to intracranial or critical organ bleeding or a bleed in another location associated with either a 2 g/dL drop in hemoglobin or need for transfusion', 'timeFrame': 'Up to 8 years'}, {'measure': 'Doubling of the serum creatinine level from baseline', 'timeFrame': 'Up to 8 years'}, {'measure': 'Decrease in eGFR>30% or 40%', 'timeFrame': 'Up to 8 years', 'description': 'Glomerular filtration rate (GRF)'}, {'measure': 'Development of an eGFR<15 mL/min or initiation of dialysis', 'timeFrame': 'Up to 8 years', 'description': 'Glomerular filtration rate (GRF)'}, {'measure': 'Development of end-stage renal disease per billing codes only', 'timeFrame': 'Up to 8 years'}, {'measure': 'Development of urine albumin-to-creatinine ratio (UACR) of 30-300 or >300', 'timeFrame': 'Up to 8 years'}, {'measure': 'Development of serum potassium > 5.6 or >6 mg/dL', 'timeFrame': 'Up to 8 years'}, {'measure': 'Development of diabetic retinopathy', 'timeFrame': 'Up to 8 years'}, {'measure': 'Myocardial infarction', 'timeFrame': 'Up to 8 years'}, {'measure': 'All-cause mortality', 'timeFrame': 'Up to 8 years'}, {'measure': 'Vascular mortality', 'timeFrame': 'Up to 8 years'}, {'measure': 'Major adverse cardiovascular event', 'timeFrame': 'Up to 8 years'}, {'measure': 'Composite of stroke, systemic embolism, vascular death', 'timeFrame': 'Up to 8 years'}, {'measure': 'Composite of stroke, systemic embolism, myocardial infarction, vascular death', 'timeFrame': 'Up to 8 years'}, {'measure': 'Composite stroke, systemic embolism, need for lower limb revascularization or major amputation', 'timeFrame': 'Up to 8 years'}, {'measure': 'Composite of >40% decrease in eGFR from baseline, eGFR<15 mL/minute, need for dialysis, renal transplant, major adverse limb event, retinopathy or all-cause death', 'timeFrame': 'Up to 8 years', 'description': 'Glomerular filtration rate (GRF)'}, {'measure': 'New-onset vascular dementia', 'timeFrame': 'Up to 8 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '34166150', 'type': 'DERIVED', 'citation': "Costa OS, O'Donnell B, Vardar B, Abdelgawwad K, Brescia CW, Sood N, Coleman CI. Kidney, limb and ophthalmic complications, and death in patients with nonvalvular atrial fibrillation and type 2 diabetes prescribed rivaroxaban or warfarin: an electronic health record analysis. Curr Med Res Opin. 2021 Sep;37(9):1493-1500. doi: 10.1080/03007995.2021.1947217. Epub 2021 Jul 8."}], 'seeAlsoLinks': [{'url': 'http://clinicaltrials.bayer.com/', 'label': 'Click here to find results for studies related to Bayer products'}]}, 'descriptionModule': {'briefSummary': "In people with type 2 diabetes, the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels.\n\nPeople with diabetes are more likely to have non-valvular atrial fibrillation (NVAF) compared to people who do not have diabetes. Having both NVAF and diabetes can increase the chances of developing other serious health conditions, like blood clots and strokes.\n\nPeople with NVAF may receive treatments to help lower the risk of blood clots. This can then help to lower the risk of having a stroke. Two of these treatments are rivaroxaban and warfarin.\n\nIn this study, the researchers will look at how well rivaroxaban works and how safe it is compared to warfarin in routine clinical practice. The study will include men and women who are at least age 18 and who have NVAF and type 2 diabetes.\n\nThe researchers in this study will use the participants' health information from an electronic database."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study is using Optum electronic health record (EHR) database. The study population of interest will be US participants with Non-valvular atrial fibrillation (NVAF) and comorbid type 2 diabetes, oral anticoagulation (OAC)-naïve and newly-initiated on rivaroxaban or warfarin, be active in the data set and have received care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be ≥18 years of age at the time of anticoagulation initiation\n* Have diagnoses of type 2 diabetes and Non-valvular atrial fibrillation (NVAF)\n* Have no record of prior oral anticoagulant (OAC) use in the prior 12-months\n* Newly initiated on Rivaroxaban or Warfarin (index date)\n* Have ≥12-months of electronic health record (EHR) activity prior to the index date and received care documented in the EHR database from at least one provider in the 12-months prior\n\nExclusion Criteria:\n\n* Evidence of valvular heart disease defined as any rheumatic heart disease, mitral stenosis or mitral valve repair/replacement\n* Pregnancy\n* Use of rivaroxaban doses other than 15 mg once daily or 20 mg once daily or the presence of other indication(s) for OAC use\n* Any prior OAC utilization per written prescription or self-report at baseline'}, 'identificationModule': {'nctId': 'NCT04509193', 'acronym': 'RIVA-DM', 'briefTitle': 'A Study Using Electronic Health Information to Learn About Rivaroxaban Compared to Warfarin in Participants With Non-valvular Atrial Fibrillation (NVAF) and Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'RIVA-DM: Effectiveness and Safety of Rivaroxaban vs. Warfarin in Nonvalvular Atrial Fibrillation and Diabetes Mellitus: Analysis of Electronic Health Record Data', 'orgStudyIdInfo': {'id': '21449'}, 'secondaryIdInfos': [{'id': 'EUPAS36634', 'type': 'OTHER', 'domain': 'ENCePP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'Participants with diagnoses of type 2 diabetes and non-valvular atrial fibrillation (NVAF) newly-initiated on rivaroxaban', 'interventionNames': ['Drug: Rivaroxaban (Xarelto, BAY59-7939)']}, {'label': 'Group B', 'description': 'Participants with diagnoses of type 2 diabetes and non-valvular atrial fibrillation (NVAF) newly-initiated on warfarin', 'interventionNames': ['Drug: Warfarin']}], 'interventions': [{'name': 'Rivaroxaban (Xarelto, BAY59-7939)', 'type': 'DRUG', 'description': 'Participants receive rivaroxaban (per written prescription, medication administration or self-report of medication use)', 'armGroupLabels': ['Group A']}, {'name': 'Warfarin', 'type': 'DRUG', 'description': 'Participants receive warfarin (per written prescription, medication administration or self-report of medication use)', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07981', 'city': 'Whippany', 'state': 'New Jersey', 'country': 'United States', 'facility': 'US Optum De-Identified EHR data', 'geoPoint': {'lat': 40.82454, 'lon': -74.4171}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Availability of this study\'s data will be determined according to Bayer\'s commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}