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

NCT03359876 | Completed

• 1 other identifier: 19721
• Study Type: observational
• Target: 16,000
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation

Keywords

Real-world study; Atrial fibrillation; Renal dysfunction; Rivaroxaban; Warfarin

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Composite endpoint, which is defined as the occurrence of ischemic stroke or intracranial hemorrhage

  Retrospective analysis from August 2011 to September 2017

• Progression to stage 5 chronic kidney disease (CKD), kidney failure or need for dialysis

  Retrospecitive analysis from August 2011 to September 2017

Study Arms (2)

Rivaroxaban

NVAF patients with renal dysfunction newly initiated on rivaroxaban 15 mg for stroke prevention

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Warfarin

NVAF patients with renal dysfunction newly initiated on vitamin K antagonist (warfarin) for stroke prevention

Drug: Warfarin sodium

Interventions

Rivaroxaban (Xarelto, BAY59-7939) DRUG

15 mg, once daily

Rivaroxaban

Warfarin sodium DRUG

Individually adjusted dose

Warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bayer: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

US Truven MarketScan

Whippany, New Jersey, 07981, United States

Location

Related Publications (1)

• Vaitsiakhovich T, Coleman CI, Kleinjung F, Vardar B, Schaefer B. Worsening of kidney function in patients with atrial fibrillation and chronic kidney disease: evidence from the real-world CALLIPER study. Curr Med Res Opin. 2022 Jun;38(6):937-945. doi: 10.1080/03007995.2022.2061705. Epub 2022 Apr 22.

  PMID: 35392744 DERIVED

Related Links

• Click here to find results for studies related to Bayer products.

MeSH Terms

Conditions

Atrial Fibrillation; Renal Insufficiency

Interventions

Rivaroxaban; Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 2, 2017
• Study Start: December 1, 2017
• Primary Completion: March 29, 2019
• Study Completion: March 29, 2019
• Last Updated: December 11, 2019

Record last verified: 2019-12

Locations

US (1)