Clinical trial NCT03359876: Clinical Outcomes Among Non-valvular Atrial Fibrillation Patients With Renal Dysfunction
Official title: Evaluation of Clinical Outcomes Among Non-valvular Atrial Fibrillation Patients With Renal Dysfunction Treated With Warfarin or Reduced Dose Rivaroxaban
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Real-world study
Atrial fibrillation
Renal dysfunction
Rivaroxaban
Warfarin
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2017-12-02
Enrollment: 16000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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


Eligibility 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.

Primary outcomes:
measure: Ischemic stroke
timeFrame: Retrospective analysis from August 2011 to September 2017
measure: Intracranial hemorrhage
timeFrame: Retrospective analysis from August 2011 to September 2017
measure: Bleeding-related hospitalization
timeFrame: Retrospective analysis from August 2011 to September 2017
Secondary outcomes:
measure: Composite endpoint, which is defined as the occurrence of ischemic stroke or intracranial hemorrhage
timeFrame: Retrospective analysis from August 2011 to September 2017
measure: Progression to stage 5 chronic kidney disease (CKD), kidney failure or need for dialysis
timeFrame: Retrospecitive analysis from August 2011 to September 2017
Other outcomes:
Locations:
city: Whippany
country: United States
facility: US Truven MarketScan
state: New Jersey
Study officials:
References:
citation: 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.