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

NCT ID: NCT03359876

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2019-03-29

Brief Summary

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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

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Conditions

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Atrial Fibrillation

Keywords

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Real-world study Atrial fibrillation Renal dysfunction Rivaroxaban Warfarin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Rivaroxaban

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

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

15 mg, once daily

Warfarin

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

Warfarin sodium

Intervention Type DRUG

Individually adjusted dose

Interventions

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Rivaroxaban (Xarelto, BAY59-7939)

15 mg, once daily

Intervention Type DRUG

Warfarin sodium

Individually adjusted dose

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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US Truven MarketScan

Whippany, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35392744 (View on PubMed)

Related Links

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https://clinicaltrials.bayer.com/

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

Other Identifiers

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19721

Identifier Type: -

Identifier Source: org_study_id