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:

NCT03746301

EudraCT Number:

Not Available

Study Completed

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
924
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many locations

Many locations, South Korea

Status
Completed
 

Trial Design