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

December 9, 2019 updated by: Bayer

Evaluation of Clinical Outcomes Among Non-valvular Atrial Fibrillation Patients With Renal Dysfunction Treated With Warfarin or Reduced Dose Rivaroxaban

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

16000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Whippany, New Jersey, United States, 07981
        • US Truven MarketScan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rivaroxaban
NVAF patients with renal dysfunction newly initiated on rivaroxaban 15 mg for stroke prevention
Drug: Rivaroxaban (Xarelto, BAY59-7939)
15 mg, once daily
Warfarin
NVAF patients with renal dysfunction newly initiated on vitamin K antagonist (warfarin) for stroke prevention
Drug: Warfarin sodium
Individually adjusted dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ischemic stroke
Time Frame: Retrospective analysis from August 2011 to September 2017
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
Retrospective analysis from August 2011 to September 2017
Intracranial hemorrhage
Time Frame: Retrospective analysis from August 2011 to September 2017
The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes
Retrospective analysis from August 2011 to September 2017
Bleeding-related hospitalization
Time Frame: Retrospective analysis from August 2011 to September 2017
The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes, Cunningham algorithm
Retrospective analysis from August 2011 to September 2017

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoint, which is defined as the occurrence of ischemic stroke or intracranial hemorrhage
Time Frame: Retrospective analysis from August 2011 to September 2017
The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes
Retrospective analysis from August 2011 to September 2017
Progression to stage 5 chronic kidney disease (CKD), kidney failure or need for dialysis
Time Frame: Retrospecitive analysis from August 2011 to September 2017
The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes
Retrospecitive analysis from August 2011 to September 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2017

Primary Completion (ACTUAL)

March 29, 2019

Study Completion (ACTUAL)

March 29, 2019

Study Registration Dates

First Submitted

November 28, 2017

First Submitted That Met QC Criteria

November 28, 2017

First Posted (ACTUAL)

December 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 11, 2019

Last Update Submitted That Met QC Criteria

December 9, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19721

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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