check_circleStudy Completed
Atrial fibrillation
Bayer Identifier:
19721
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Clinical outcomes among non-valvular atrial fibrillation patients with renal dysfunction
Trial purpose
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
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
16000Trial Dates
December 2017 - March 2019Phase
N/ACould I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | US Truven MarketScan | Whippany, 07981, United States |
Primary Outcome
- Ischemic strokeThe 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 codesdate_rangeTime Frame:Retrospective analysis from August 2011 to September 2017
- Intracranial hemorrhageThe study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codesdate_rangeTime Frame:Retrospective analysis from August 2011 to September 2017
- Bleeding-related hospitalizationThe study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes, Cunningham algorithmdate_rangeTime Frame:Retrospective analysis from August 2011 to September 2017
Secondary Outcome
- Composite endpoint, which is defined as the occurrence of ischemic stroke or intracranial hemorrhageThe study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codesdate_rangeTime Frame:Retrospective analysis from August 2011 to September 2017
- Progression to stage 5 chronic kidney disease (CKD), kidney failure or need for dialysisThe study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codesdate_rangeTime Frame:Retrospecitive analysis from August 2011 to September 2017
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A