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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS36634 | Other Identifier | ENCePP |
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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In people with type 2 diabetes, the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels.
People with diabetes are more likely to have non-valvular atrial fibrillation (NVAF) compared to people who do not have diabetes. Having both NVAF and diabetes can increase the chances of developing other serious health conditions, like blood clots and strokes.
People with NVAF may receive treatments to help lower the risk of blood clots. This can then help to lower the risk of having a stroke. Two of these treatments are rivaroxaban and warfarin.
In this study, the researchers will look at how well rivaroxaban works and how safe it is compared to warfarin in routine clinical practice. The study will include men and women who are at least age 18 and who have NVAF and type 2 diabetes.
The researchers in this study will use the participants' health information from an electronic database.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Participants with diagnoses of type 2 diabetes and non-valvular atrial fibrillation (NVAF) newly-initiated on rivaroxaban |
| |
| Group B | Participants with diagnoses of type 2 diabetes and non-valvular atrial fibrillation (NVAF) newly-initiated on warfarin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | Participants receive rivaroxaban (per written prescription, medication administration or self-report of medication use) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of stroke or systemic embolism | Up to 8 years | |
| Any major or clinically-relevant nonmajor bleed resulting in hospitalization | Up to 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Ischemic stroke | Up to 8 years | |
| Systemic embolism | Up to 8 years | |
| Need for revascularization or major amputation of the lower limb |
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Inclusion Criteria:
Exclusion Criteria:
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The study is using Optum electronic health record (EHR) database. The study population of interest will be US participants with Non-valvular atrial fibrillation (NVAF) and comorbid type 2 diabetes, oral anticoagulation (OAC)-naïve and newly-initiated on rivaroxaban or warfarin, be active in the data set and have received care.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US Optum De-Identified EHR data | Whippany | New Jersey | 07981 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34166150 | Derived | Costa OS, O'Donnell B, Vardar B, Abdelgawwad K, Brescia CW, Sood N, Coleman CI. Kidney, limb and ophthalmic complications, and death in patients with nonvalvular atrial fibrillation and type 2 diabetes prescribed rivaroxaban or warfarin: an electronic health record analysis. Curr Med Res Opin. 2021 Sep;37(9):1493-1500. doi: 10.1080/03007995.2021.1947217. Epub 2021 Jul 8. |
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Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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| Warfarin | Drug | Participants receive warfarin (per written prescription, medication administration or self-report of medication use) |
|
| Up to 8 years |
| Intracranial hemorrhage | Up to 8 years |
| Critical organ bleeding per ISTH categories | The categories for critical organ bleeding as per ISTH definition are: intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome. | Up to 8 years |
| Any extracranial bleeding | Up to 8 years |
| Any hospitalization due to intracranial or critical organ bleeding or a bleed in another location associated with either a 2 g/dL drop in hemoglobin or need for transfusion | Up to 8 years |
| Doubling of the serum creatinine level from baseline | Up to 8 years |
| Decrease in eGFR>30% or 40% | Glomerular filtration rate (GRF) | Up to 8 years |
| Development of an eGFR<15 mL/min or initiation of dialysis | Glomerular filtration rate (GRF) | Up to 8 years |
| Development of end-stage renal disease per billing codes only | Up to 8 years |
| Development of urine albumin-to-creatinine ratio (UACR) of 30-300 or >300 | Up to 8 years |
| Development of serum potassium > 5.6 or >6 mg/dL | Up to 8 years |
| Development of diabetic retinopathy | Up to 8 years |
| Myocardial infarction | Up to 8 years |
| All-cause mortality | Up to 8 years |
| Vascular mortality | Up to 8 years |
| Major adverse cardiovascular event | Up to 8 years |
| Composite of stroke, systemic embolism, vascular death | Up to 8 years |
| Composite of stroke, systemic embolism, myocardial infarction, vascular death | Up to 8 years |
| Composite stroke, systemic embolism, need for lower limb revascularization or major amputation | Up to 8 years |
| Composite of >40% decrease in eGFR from baseline, eGFR<15 mL/minute, need for dialysis, renal transplant, major adverse limb event, retinopathy or all-cause death | Glomerular filtration rate (GRF) | Up to 8 years |
| New-onset vascular dementia | Up to 8 years |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| 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 |
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