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

Atrial Fibrillation Clinical Trial

— CALLIPER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03359876
• Other study ID #: 19721
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: March 29, 2019

Study information

• Verified date: December 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16000
• Est. completion date: March 29, 2019
• Est. primary completion date: March 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Renal Insufficiency

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
15 mg, once daily
• Warfarin sodium
Individually adjusted dose

Locations

Country	Name	City	State
United States	US Truven MarketScan	Whippany	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemic stroke	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	Retrospective analysis from August 2011 to September 2017
Primary	Intracranial hemorrhage	The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes	Retrospective analysis from August 2011 to September 2017
Primary	Bleeding-related hospitalization	The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes, Cunningham algorithm	Retrospective analysis from August 2011 to September 2017
Secondary	Composite endpoint, which is defined as the occurrence of ischemic stroke or intracranial hemorrhage	The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes	Retrospective analysis from August 2011 to September 2017
Secondary	Progression to stage 5 chronic kidney disease (CKD), kidney failure or need for dialysis	The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes	Retrospecitive analysis from August 2011 to September 2017

External Links

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