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 with renal dysfunction in routine clinical practice. The study has a retrospective design, and will be conducted in the US Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases
Study Type
OBSERVATIONAL
Enrollment
16,000
15 mg, once daily
Individually adjusted dose
US Truven MarketScan
Whippany, New Jersey, United States
Ischemic stroke
The study outcomes will be defined based on the International Classification of Diseases, 9th- and 10th-revision, Clinical Modification (ICD-9/10-CM) diagnosis codes, Current Procedural Technology, 4th-revision (CPT-4) and Healthcare Common Procedure Coding System (HCPCS) procedure codes
Time frame: Retrospective analysis from August 2011 to September 2017
Intracranial hemorrhage
The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes
Time frame: Retrospective analysis from August 2011 to September 2017
Bleeding-related hospitalization
The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes, Cunningham algorithm
Time frame: Retrospective analysis from August 2011 to September 2017
Composite endpoint, which is defined as the occurrence of ischemic stroke or intracranial hemorrhage
The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes
Time frame: Retrospective analysis from August 2011 to September 2017
Progression to stage 5 chronic kidney disease (CKD), kidney failure or need for dialysis
The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes
Time frame: Retrospecitive analysis from August 2011 to September 2017
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