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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Warfarin sodium

• Registration Number: NCT03359876
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-11-28
• Study Start: 2017-12-01
• Study First Posted: 2017-12-02
• Primary Completion: 2019-03-29
• Study Completion: 2019-03-29
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-09
• Last Update Posted: 2019-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Ischemic stroke	Retrospective analysis from August 2011 to September 2017	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	Retrospective analysis from August 2011 to September 2017	The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes
Bleeding-related hospitalization	Retrospective analysis from August 2011 to September 2017	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

Name	Time	Method
Progression to stage 5 chronic kidney disease (CKD), kidney failure or need for dialysis	Retrospecitive analysis from August 2011 to September 2017	The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes
Composite endpoint, which is defined as the occurrence of ischemic stroke or intracranial hemorrhage	Retrospective analysis from August 2011 to September 2017	The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes

Trial Locations

Locations (1)

US Truven MarketScan; 🇺🇸 Whippany, New Jersey, United States