Non-valvular Atrial Fibrillation (NVAF)
Conditions
Keywords
Stroke
Brief summary
In this study researchers want to learn more about on the safety of the drug Xarelto. The study will enroll patients for whom the treating doctor are prescribing Xarelto for the prevention of brain attack or the prevention of blockage of an artery in the non-central nervous system. Only patients suffering from decreased renal function and irregular heart beat will be considered. The study plans to include 500 Taiwanese adult male and female patients with the age above 20 years. Patients will be followed up based on routine medical practice over a period of 12 months and information on their well-being and any medical events will collected.
Interventions
DRUGRivaroxaban (Xarelto, BAY59-7939)
The adminstration dose is decided by the attending physician in advance based on the patients' CrCl and in compliance with local market authorization of rivaroxaban.
Sponsors
Janssen Research & Development, LLC
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female and male patients ≥ 20 years of age * Diagnosis of non-valvular atrial fibrillation (NVAF) * Patients for whom the decision to initiate treatment with rivaroxaban is made as per physician's routine treatment practice * Previously documented CrCl of 15-50 mL/min within 6 months before enrollment (last available value)
Exclusion criteria
* Contraindications for rivaroxaban according to the local market authorization/ Summary of Product Characteristics * Patients participating in an investigational program with interventions outside of routine clinical practice. * Planned treatment with other anticoagulants * Expected renal-replacement therapy within the next 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major bleeding events | Up to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of All-cause mortality | Up to 12 months |
| Occurrence of non-major bleeding events | Up to 12 months |
| Occurrence of adverse events (AEs) and serious adverse events (SAEs) | Up to 12 months |
| Day(s) of rivaroxaban treatment: start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy (in case of treatment discontinuation, switch, or interruption, the reason will be recorded) | Up to 12 months |
| Changes in creatinine clearance (CrCl) from baseline | Up to 12 months |
| Occurrence of symptomatic thromboembolic events | Up to 12 months |
Countries
Taiwan
Outcome results
None listed