check_circleStudy Completed
Atrial fibrillation
Bayer Identifier:
21449
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A study using electronic health information to learn about rivaroxaban compared to warfarin in participants with non-valvular atrial fibrillation (NVAF) and diabetes
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
116049Trial Dates
August 2020 - July 2021Phase
Phase 4Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | US Optum De-Identified EHR data | Whippany, 07981, United States |
Primary Outcome
- Composite of stroke or systemic embolismdate_rangeTime Frame:Up to 8 years
- Any major or clinically-relevant nonmajor bleed resulting in hospitalizationdate_rangeTime Frame:Up to 8 years
Secondary Outcome
- Ischemic strokedate_rangeTime Frame:Up to 8 years
- Systemic embolismdate_rangeTime Frame:Up to 8 years
- Need for revascularization or major amputation of the lower limbdate_rangeTime Frame:Up to 8 years
- Intracranial hemorrhagedate_rangeTime Frame:Up to 8 years
- Critical organ bleeding per ISTH categoriesThe categories for critical organ bleeding as per ISTH definition are: intracranial, intraspinal, intraocular, retroperitoneal, intra‐articular or pericardial, or intramuscular with compartment syndrome.date_rangeTime Frame:Up to 8 years
- Any extracranial bleedingdate_rangeTime Frame: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 transfusiondate_rangeTime Frame:Up to 8 years
- Doubling of the serum creatinine level from baselinedate_rangeTime Frame:Up to 8 years
- Decrease in eGFR>30% or 40%Glomerular filtration rate (GRF)date_rangeTime Frame:Up to 8 years
- Development of an eGFR<15 mL/min or initiation of dialysisGlomerular filtration rate (GRF)date_rangeTime Frame:Up to 8 years
- Development of end-stage renal disease per billing codes onlydate_rangeTime Frame:Up to 8 years
- Development of urine albumin-to-creatinine ratio (UACR) of 30-300 or >300date_rangeTime Frame:Up to 8 years
- Development of serum potassium > 5.6 or >6 mg/dLdate_rangeTime Frame:Up to 8 years
- Development of diabetic retinopathydate_rangeTime Frame:Up to 8 years
- Myocardial infarctiondate_rangeTime Frame:Up to 8 years
- All-cause mortalitydate_rangeTime Frame:Up to 8 years
- Vascular mortalitydate_rangeTime Frame:Up to 8 years
- Major adverse cardiovascular eventdate_rangeTime Frame:Up to 8 years
- Composite of stroke, systemic embolism, vascular deathdate_rangeTime Frame:Up to 8 years
- Composite of stroke, systemic embolism, myocardial infarction, vascular deathdate_rangeTime Frame:Up to 8 years
- Composite stroke, systemic embolism, need for lower limb revascularization or major amputationdate_rangeTime Frame: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 deathGlomerular filtration rate (GRF)date_rangeTime Frame:Up to 8 years
- New-onset vascular dementiadate_rangeTime Frame:Up to 8 years
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A