check_circleStudy Completed

Atrial fibrillation

Clinical outcomes among non-valvular atrial fibrillation patients with renal dysfunction

Trial purpose

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

Key Participants Requirements

Sex

All

Age

18 - N/A

Trial summary

Enrollment Goal
16000
Trial Dates
December 2017 - March 2019
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
US Truven MarketScanWhippany, 07981, United States

Primary Outcome

  • 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
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime Frame:
    Retrospective analysis from August 2011 to September 2017

Secondary Outcome

  • 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
    date_rangeTime 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
    date_rangeTime Frame:
    Retrospecitive analysis from August 2011 to September 2017

Trial design

Evaluation of clinical outcomes among non-valvular atrial fibrillation patients with renal dysfunction treated with warfarin or reduced dose rivaroxaban
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A