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

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Bayer

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Drug: Rivaroxaban (Xarelto, BAY59-7939)
Drug: Warfarin sodium

Study type

Observational

Funder types

Industry

Identifiers

NCT03359876
19721

Details and patient eligibility

About

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

Enrollment

16,000 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

16,000 participants in 2 patient groups

Rivaroxaban
Description:
NVAF patients with renal dysfunction newly initiated on rivaroxaban 15 mg for stroke prevention
Treatment:
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Warfarin
Description:
NVAF patients with renal dysfunction newly initiated on vitamin K antagonist (warfarin) for stroke prevention
Treatment:
Drug: Warfarin sodium

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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