Trial Condition(s):
Non-valvular Atrial fibrillation (NVAF)
Xarelto on prevention of stroke and non-Central Nervous Systemic embolism in Renally impaired Korean patients with Non-valvular Atrial fibrillation (XARENAL)
Bayer Identifier:
20286
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The purpose of the study is to evaluate the safety and effectiveness of Xarelto in renally impaired patients
with NVAF under routine practice conditions.
The information collected in the XARENAL study will help to understand how renally impared patients with
NVAF are treated in the real-world setting and what the outcome for the patients is under those conditions.
Inclusion Criteria
- Female and male patients ≥ 19 years of age - Diagnosis of NVAF - Patients for whom the decision to initiate treatment with rivaroxaban has already been made as per physician’s routine treatment practice - Previous documented creatinine clearance rate of 15-49mL/min within 6 months before enrollment - Written informed consent of the patient
Exclusion Criteria
- Contraindications for rivaroxaban according to the current Korean market authorization and Summary of Product Characteristics (SmPC). - 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, South Korea | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Xarelto® on prevention of stroke and non-Central Nervous Systemic (CNS) embolism in Renally impaired Korean patients with Non-valvular Atrial fibrillation (NVAF)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Incidence proportion of major bleedingIncidence proportion of major bleeding events collects as serious or non-serious AEs and defined as overt bleeding associated with: - a fall in haemoglobin of ≥2 g/dL, or - a transfusion of ≥2 units of packed red blood cells or whole blood, or - occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra muscular with compartment syndrome, retroperitoneal), or - death.Timeframe: Up to 12 months
Secondary Outcome
- Occurrence of AEs and SAEsTimeframe: Up to 12 months
- Occurrence of all-cause mortalityTimeframe: Up to 12 months
- Occurrence of Non-major bleedingNon-major bleeding events collected as SAEs or non-serious AEs and defined as all bleeding events that do not fall in the category of major bleeding.Timeframe: Up to 12 months
- Incidence proportion of Symptomatic thromboembolic eventsSymptomatic thromboembolic events collected as SAEs or non-serious AEs.Timeframe: Up to 12 months
- Days of rivaroxaban treatmentStart 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
- The change in creatinine clearance from baselineTimeframe: At month 3,6,9 and 12
Additional Information
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