Trial Condition(s):
Non-valvular Atrial fibrillation (NVAF)
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 (XARETO)
Bayer Identifier:
20901
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many Locations Many Locations, Taiwan, China | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Xarelto® for the prevention of stroke and noncentral nervous systemic embolism in non-valvular atrial fibrillation with REnal impairment in Taiwanese population.
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Major bleeding eventsTimeframe: Up to 12 months
Secondary Outcome
- Occurrence of adverse events (AEs) and serious adverse events (SAEs)Timeframe: Up to 12 months
- Occurrence of All-cause mortalityTimeframe: Up to 12 months
- Occurrence of non-major bleeding eventsTimeframe: Up to 12 months
- Occurrence of symptomatic thromboembolic eventsTimeframe: 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)Timeframe: Up to 12 months
- Changes in creatinine clearance (CrCl) from baselineTimeframe: Up to 12 months
Additional Information
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