Status:
COMPLETED
Clinical Outcomes Among Non-valvular Atrial Fibrillation Patients With Renal Dysfunction
Lead Sponsor:
Bayer
Collaborating Sponsors:
Janssen Research & Development, LLC
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
The objective of the study is to evaluate the effectiveness and safety of the reduced dose rivaroxaban (15 mg once daily) as compared to warfarin in non-valvular atrial fibrillation (NVAF) patients wi...
Eligibility Criteria
Inclusion
- have to be adults (≥18 years of age)
- newly-initiated on warfarin or rivaroxaban 15 mg (index event, index drug)
- have at least 365 days of continuous medical and prescription benefits prior to the index event (baseline period)
- have at least two diagnosis codes for NVAF (on outpatient or inpatient claims, at two different days) and
- have at least one diagnosis code (inpatient or outpatient) indicating renal dysfunction in the baseline period
Exclusion
- valvular AF (at least one inpatient diagnosis in the baseline period)
- pregnancy (inpatient or outpatient diagnosis in the baseline period)
- transient cause of AF (inpatient or outpatient diagnosis in the baseline period)
- venous thromboembolism (pulmonary embolism or deep vein thrombosis) (one inpatient or outpatient diagnosis 60 days prior to or on the index date) or
- overcame a hip or knee replacement (one inpatient diagnosis or procedure code 60 days prior to or on the index date)
- have a pharmacy claim for an oral anticoagulation (OAC) dispensation (warfarin, apixaban, dabigatran, edoxaban or rivaroxaban) in the baseline period
- receive both warfarin and rivaroxaban 15 mg on the index date
- have an end-stage kidney disease or be on dialysis (one inpatient or outpatient diagnosis or procedure code in the baseline period).
- For the main analysis, patients having malignant cancers (inpatient or outpatient diagnosis in the baseline period) will be excluded. A sensitivity analysis, omitting this exclusion criterion, will be performed.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 29 2019
Estimated Enrollment :
16000 Patients enrolled
Trial Details
Trial ID
NCT03359876
Start Date
December 1 2017
End Date
March 29 2019
Last Update
December 11 2019
Active Locations (1)
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1
US Truven MarketScan
Whippany, New Jersey, United States, 07981