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Clinical Trial Details

Trial ID: L6601
Source ID: NCT04509193
Associated Drug: Rivaroxaban (Xarelto, Bay59-7939)
Title: A Study Using Electronic Health Information to Learn About Rivaroxaban Compared to Warfarin in Participants With Non-valvular Atrial Fibrillation (NVAF) and Diabetes
Acronym: RIVA-DM
Status: COMPLETED
Study Results: NO
Results:
Conditions: Atrial Fibrillation
Interventions: DRUG: Rivaroxaban (Xarelto, BAY59-7939)|DRUG: Warfarin
Outcome Measures: Primary: Composite of stroke or systemic embolism, Up to 8 years|Any major or clinically-relevant nonmajor bleed resulting in hospitalization, Up to 8 years | Secondary: Ischemic stroke, Up to 8 years|Systemic embolism, Up to 8 years|Need for revascularization or major amputation of the lower limb, Up to 8 years|Intracranial hemorrhage, Up to 8 years|Critical organ bleeding per ISTH categories, The categories for critical organ bleeding as per ISTH definition are: intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome., Up to 8 years|Any extracranial bleeding, Up to 8 years|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, Up to 8 years|Doubling of the serum creatinine level from baseline, Up to 8 years|Decrease in eGFR>30% or 40%, Glomerular filtration rate (GRF), Up to 8 years|Development of an eGFR<15 mL/min or initiation of dialysis, Glomerular filtration rate (GRF), Up to 8 years|Development of end-stage renal disease per billing codes only, Up to 8 years|Development of urine albumin-to-creatinine ratio (UACR) of 30-300 or >300, Up to 8 years|Development of serum potassium > 5.6 or >6 mg/dL, Up to 8 years|Development of diabetic retinopathy, Up to 8 years|Myocardial infarction, Up to 8 years|All-cause mortality, Up to 8 years|Vascular mortality, Up to 8 years|Major adverse cardiovascular event, Up to 8 years|Composite of stroke, systemic embolism, vascular death, Up to 8 years|Composite of stroke, systemic embolism, myocardial infarction, vascular death, Up to 8 years|Composite stroke, systemic embolism, need for lower limb revascularization or major amputation, Up to 8 years|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, Glomerular filtration rate (GRF), Up to 8 years|New-onset vascular dementia, Up to 8 years
Sponsor/Collaborators: Sponsor: Bayer | Collaborators: Janssen Research & Development, LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 116049
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2020-08-21
Completion Date: 2021-07-31
Results First Posted:
Last Update Posted: 2022-06-15
Locations: US Optum De-Identified EHR data, Whippany, New Jersey, 07981, United States
URL: https://clinicaltrials.gov/show/NCT04509193