An observational study in Atrial Fibrillation, sponsored by Bayer. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-11.
Sponsored by Bayer · Observational
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Among 64 studies in Atrial Fibrillation by Bayer — 1 open to participants now, 1 under way, none of them phase 3. Atrial Fibrillation · Bayer.
Among the 64 studies in Atrial Fibrillation by Bayer, this one is the 19th largest by enrollment of the 51 observational ones that give a count, is one of 6 that started in 2017, is one of 51 observational ones, and was the 45th registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 960 are open to participants now.
Browse Atrial Fibrillation studies →1 of the 64 studies in Atrial Fibrillation by Bayer is open now, in 8 countries. Recruiting first, the newest first:
Bayer · Sites in United States, Belgium, Bulgaria and 5 more countries
Ages 18–85
By country, each count listing its studies:
Of the 611 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 43 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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64 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 6 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 16,000 is above the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Median enrollment 100 across the 13 interventional studies, 3,055 across the 51 observational. Of the 61 that completed or were terminated, 4 (7%) have results posted.
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Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 64 studies in Atrial Fibrillation by Bayer, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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
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.
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Exclusion Criteria:
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.
NVAF patients with renal dysfunction newly initiated on rivaroxaban 15 mg for stroke prevention
Drug: Rivaroxaban (Xarelto, BAY59-7939)
NVAF patients with renal dysfunction newly initiated on vitamin K antagonist (warfarin) for stroke prevention
Drug: Warfarin sodium
15 mg, once daily
Individually adjusted dose
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
Time frame: 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
Time frame: 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
Time frame: Retrospective analysis from August 2011 to September 2017
Composite endpoint, which is defined as the occurrence of ischemic stroke or intracranial hemorrhage
The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes
Time frame: Retrospective analysis from August 2011 to September 2017
Progression to stage 5 chronic kidney disease (CKD), kidney failure or need for dialysis
The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes
Time frame: Retrospecitive analysis from August 2011 to September 2017
Ran from Dec 2017 to primary completion in Mar 2019, 15 months.
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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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