Evaluation of Clinical outcomes among non-valvular atrial fibrillatIon patients with renal dysfunction treated with warfarin or reduced dose rivaroxaban (CALLIPER)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  RIVAROXABAN
• Anatomical Therapeutic Chemical (ATC) code:
  (B01AA03) warfarin

  warfarin
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  All the insured individuals included in the Truven Health MarketScan databases.; To be included in the present study, patients 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), at least two diagnosis codes for NVAF (on outpatient or inpatient claims, at two different days) and at least one diagnosis code (inpatient or outpatient) indicating renal dysfunction in the baseline period.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  11000

Study design details

• Main study objective:
  The objective of the study is to evaluate the effectiveness and safety of the reduced dose rivaroxaban (15mg 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.
• Outcomes:
  Ischemic stroke,Intracranial hemorrhage,Bleeding-related hospitalization, Composite endpoint, which is defined as the occurrence of ischemic stroke or intracranial hemorrhage, Progression to stage 5 chronic kidney disease, kidney failure or need for dialysis
• Data analysis plan:
  Stabilized inverse probability of treatment weighting (IPTW) methodology based on the propensity score will be utilized to adjust for potential confounding. Additionally, a propensity score matching analysis and a conventional multiple logistic regression analysis will be conducted. The incidence rates of the study outcome measures will be reported as the number of events per 100 person-years. Cox proportional hazards regression model will be applied to estimate adjusted hazard ratios.