Trial Condition(s):
Atrial Fibrillation
A study using electronic health information to learn about rivaroxaban compared to warfarin in participants with non-valvular atrial fibrillation (NVAF) and diabetes (RIVA-DM)
Bayer Identifier:
21449
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- Be ≥18 years of age at the time of anticoagulation initiation - Have diagnoses of type 2 diabetes and Non-valvular atrial fibrillation (NVAF) - Have no record of prior oral anticoagulant (OAC) use in the prior 12-months - Newly initiated on Rivaroxaban or Warfarin (index date) - Have ≥12-months of electronic health record (EHR) activity prior to the index date and received care documented in the EHR database from at least one provider in the 12-months prior
Exclusion Criteria
- Evidence of valvular heart disease defined as any rheumatic heart disease, mitral stenosis or mitral valve repair/replacement - Pregnancy - Use of rivaroxaban doses other than 15 mg once daily or 20 mg once daily or the presence of other indication(s) for OAC use - Any prior OAC utilization per written prescription or self-report at baseline
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations US Optum De-Identified EHR data Whippany, United States, 07981 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
RIVA-DM: Effectiveness and Safety of Rivaroxaban vs. Warfarin in Nonvalvular Atrial Fibrillation and Diabetes Mellitus: Analysis of Electronic Health Record Data
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Composite of stroke or systemic embolismTimeframe: Up to 8 years
- Any major or clinically-relevant nonmajor bleed resulting in hospitalizationTimeframe: Up to 8 years
Secondary Outcome
- Ischemic strokeTimeframe: Up to 8 years
- Systemic embolismTimeframe: Up to 8 years
- Need for revascularization or major amputation of the lower limbTimeframe: Up to 8 years
- Intracranial hemorrhageTimeframe: 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.Timeframe: Up to 8 years
- Any extracranial bleedingTimeframe: 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 transfusionTimeframe: Up to 8 years
- Doubling of the serum creatinine level from baselineTimeframe: Up to 8 years
- Decrease in eGFR>30% or 40%Glomerular filtration rate (GRF)Timeframe: Up to 8 years
- Development of an eGFR<15 mL/min or initiation of dialysisGlomerular filtration rate (GRF)Timeframe: Up to 8 years
- Development of end-stage renal disease per billing codes onlyTimeframe: Up to 8 years
- Development of urine albumin-to-creatinine ratio (UACR) of 30-300 or >300Timeframe: Up to 8 years
- Development of serum potassium > 5.6 or >6 mg/dLTimeframe: Up to 8 years
- Development of diabetic retinopathyTimeframe: Up to 8 years
- Myocardial infarctionTimeframe: Up to 8 years
- All-cause mortalityTimeframe: Up to 8 years
- Vascular mortalityTimeframe: Up to 8 years
- Major adverse cardiovascular eventTimeframe: Up to 8 years
- Composite of stroke, systemic embolism, vascular deathTimeframe: Up to 8 years
- Composite of stroke, systemic embolism, myocardial infarction, vascular deathTimeframe: Up to 8 years
- Composite stroke, systemic embolism, need for lower limb revascularization or major amputationTimeframe: 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)Timeframe: Up to 8 years
- New-onset vascular dementiaTimeframe: Up to 8 years
Additional Information
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