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OpenTrials
Completed

NCT Number: NCT03359876

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

15 mg, once daily

Warfarin sodium

Drug

Individually adjusted dose

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

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

Acronym: CALLIPER

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 2, 2017
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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