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

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ClinicalTrials.gov Identifier: NCT03359876
Recruitment Status : Active, not recruiting
First Posted : December 2, 2017
Last Update Posted : September 5, 2018
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Brief Summary:
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

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Warfarin sodium

Study Type : Observational
Estimated Enrollment : 11000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Clinical Outcomes Among Non-valvular Atrial Fibrillation Patients With Renal Dysfunction Treated With Warfarin or Reduced Dose Rivaroxaban
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359876


Locations
United States, New Jersey
US Truven MarketScan
Whippany, New Jersey, United States, 07981
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03359876     History of Changes
Other Study ID Numbers: 19721
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Real-world study
Atrial fibrillation
Renal dysfunction
Rivaroxaban
Warfarin

Additional relevant MeSH terms:
Atrial Fibrillation
Renal Insufficiency
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Kidney Diseases
Urologic Diseases
Warfarin
Rivaroxaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action