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CompletedNCT03359876CALLIPERUpdated Dec 11, 2019

Clinical Outcomes Among Non-valvular Atrial Fibrillation Patients With Renal Dysfunction

An observational study in Atrial Fibrillation, sponsored by Bayer. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-11.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
16,000
Ages
18 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Atrial Fibrillation

Keywords

  • Real-world study
  • Atrial fibrillation
  • Renal dysfunction
  • Rivaroxaban
  • Warfarin
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The source population of this study is all the insured individuals included in the US Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases.To be included in the present study, adult patients have to be diagnosed with NVAF, have renal dysfunction and be newly-initiated on warfarin or rivaroxaban 15 mg for stroke prevention.

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • 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.

04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
16,000 participants (actual)
Patient registry
No

Groups and cohorts

  • Rivaroxaban

    NVAF patients with renal dysfunction newly initiated on rivaroxaban 15 mg for stroke prevention

    Drug: Rivaroxaban (Xarelto, BAY59-7939)

  • Warfarin

    NVAF patients with renal dysfunction newly initiated on vitamin K antagonist (warfarin) for stroke prevention

    Drug: Warfarin sodium

Interventions

  • DrugRivaroxaban (Xarelto, BAY59-7939)

    15 mg, once daily

  • DrugWarfarin sodium

    Individually adjusted dose

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

06

Study locations

1 site
  • US Truven MarketScan
    Whippany, New Jersey 07981, United States
07

References and documents

Publications

  • Vaitsiakhovich T, Coleman CI, Kleinjung F, Vardar B, Schaefer B. Worsening of kidney function in patients with atrial fibrillation and chronic kidney disease: evidence from the real-world CALLIPER study. Curr Med Res Opin. 2022 Jun;38(6):937-945. doi: 10.1080/03007995.2022.2061705. Epub 2022 Apr 22. PubMed 35392744 ↗
08

Registry details

Key details

Study ID
NCT03359876
Lead sponsor
Bayer
Collaborators
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Dec 2, 2017
Start date
Dec 1, 2017
Primary completion
Mar 29, 2019
Completion
Mar 29, 2019
Last update
Dec 11, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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