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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03359876
Recruitment Status : Active, not recruiting
First Posted : December 2, 2017
Last Update Posted : September 27, 2018
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

November 28, 2017
December 2, 2017
September 27, 2018
December 1, 2017
December 31, 2018   (Final data collection date for primary outcome measure)
  • Ischemic stroke [ Time Frame: Retrospective analysis from August 2011 to December 2016 ]
    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
  • Intracranial hemorrhage [ Time Frame: Retrospective analysis from August 2011 to December 2016 ]
    The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes
  • Bleeding-related hospitalization [ Time Frame: Retrospective analysis from August 2011 to December 2016 ]
    The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes, Cunningham algorithm
Same as current
Complete list of historical versions of study NCT03359876 on ClinicalTrials.gov Archive Site
Composite endpoint, which is defined as the occurrence of ischemic stroke or intracranial hemorrhage [ Time Frame: Retrospective analysis from August 2011 to December 2016 ]
The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes
Same as current
Not Provided
Not Provided
 
Clinical Outcomes Among Non-valvular Atrial Fibrillation Patients With Renal Dysfunction
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
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
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.
Atrial Fibrillation
  • Drug: Rivaroxaban (Xarelto, BAY59-7939)
    15 mg, once daily
  • Drug: Warfarin sodium
    Individually adjusted dose
  • Rivaroxaban
    NVAF patients with renal dysfunction newly initiated on rivaroxaban 15 mg for stroke prevention
    Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)
  • Warfarin
    NVAF patients with renal dysfunction newly initiated on vitamin K antagonist (warfarin) for stroke prevention
    Intervention: Drug: Warfarin sodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
11000
Same as current
December 31, 2018
December 31, 2018   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT03359876
19721
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Bayer
Bayer
Janssen Research & Development, LLC
Not Provided
Bayer
September 2018