Study to Gain Information on the Drug Xarelto for the Prevention of Brain Attack and Blockage of an Artery in the Non-central Nervous System Due to Irregular Heartbeat in Taiwanese Patients Suffering From Decreased Renal Function
Completed
- Conditions
- Non-valvular Atrial Fibrillation (NVAF)
- Interventions
- Registration Number
- NCT04356989
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 493
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Rivaroxaban Rivaroxaban (Xarelto, BAY59-7939) Adult NVAF patients with renal impairment, who are prescribed with rivaroxaban to prevent stroke or non-central nervous system (CNS) systemic embolism (SE).
- Primary Outcome Measures
Name Time Method Major bleeding events Up to 12 months
- Secondary Outcome Measures
Name Time Method Occurrence of adverse events (AEs) and serious adverse events (SAEs) Up to 12 months Occurrence of All-cause mortality Up to 12 months Occurrence of symptomatic thromboembolic events Up to 12 months Occurrence of non-major bleeding events 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
Trial Locations
- Locations (1)
Many Locations
🇨🇳Multiple Locations, Taiwan