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
  • - 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
  • - 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.

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