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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban | NVAF patients with renal dysfunction newly initiated on rivaroxaban 15 mg for stroke prevention |
| |
| Warfarin | NVAF patients with renal dysfunction newly initiated on vitamin K antagonist (warfarin) for stroke prevention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | 15 mg, once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Retrospective analysis from August 2011 to September 2017 |
| Progression to stage 5 chronic kidney disease (CKD), kidney failure or need for dialysis |
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Inclusion Criteria:
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.
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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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US Truven MarketScan | Whippany | New Jersey | 07981 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35392744 | Derived | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| Warfarin sodium |
| Drug |
Individually adjusted dose |
|
The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes |
| Retrospecitive analysis from August 2011 to September 2017 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |