check_circleStudy Completed

Non-valvular Atrial fibrillation (NVAF)

Bayer Identifier:

20286

ClinicalTrials.gov Identifier:

NCT03746301

EudraCT Number:

Not Available

EU CT Number:

Not Available
Xarelto on prevention of stroke and non-Central Nervous Systemic embolism in Renally impaired Korean patients with Non-valvular Atrial fibrillation

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.

Key Participants Requirements

Sex

All

Age

19 - N/A
  • - 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
  • - 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
December 2018 - December 2021
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, Korea, Republic Of

Primary Outcome

  • Incidence proportion of major bleeding
    Incidence 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.
    date_rangeTime Frame:
    Up to 12 months

Secondary Outcome

  • Occurrence of AEs and SAEs
    date_rangeTime Frame:
    Up to 12 months
  • Occurrence of all-cause mortality
    date_rangeTime Frame:
    Up to 12 months
  • Occurrence of Non-major bleeding
    Non-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.
    date_rangeTime Frame:
    Up to 12 months
  • Incidence proportion of Symptomatic thromboembolic events
    Symptomatic thromboembolic events collected as SAEs or non-serious AEs.
    date_rangeTime Frame:
    Up to 12 months
  • Days 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)
    date_rangeTime Frame:
    Up to 12 months
  • The change in creatinine clearance from baseline
    date_rangeTime Frame:
    At month 3,6,9 and 12

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
N/A

Additional Information

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