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Xarelto on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-valvular Atrial Fibrillation (XARENAL)

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ClinicalTrials.gov Identifier: NCT03746301
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : September 13, 2019
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment
Non-valvular Atrial Fibrillation (NVAF) Drug: Rivaroxaban(Xarelto,BAY 59-7939)

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Xarelto® on Prevention of Stroke and Non-Central Nervous Systemic (CNS) Embolism in Renally Impaired Korean Patients With Non-valvular Atrial Fibrillation (NVAF)
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Group/Cohort Intervention/treatment
Treatment
Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions.
Drug: Rivaroxaban(Xarelto,BAY 59-7939)
10mg, 15mg and 20 mg film-coated tablets




Primary Outcome Measures :
  1. Incidence proportion of major bleeding [ Time Frame: Up to 12 months ]

    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.


Secondary Outcome Measures :
  1. Occurrence of AEs and SAEs [ Time Frame: Up to 12 months ]
  2. Occurrence of all-cause mortality [ Time Frame: Up to 12 months ]
  3. Occurrence of Non-major bleeding [ Time Frame: Up to 12 months ]
    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.

  4. Incidence proportion of Symptomatic thromboembolic events [ Time Frame: Up to 12 months ]
    Symptomatic thromboembolic events collected as SAEs or non-serious AEs.

  5. Days of rivaroxaban treatment [ Time Frame: Up to 12 months ]
    Start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy(in case of treatment discontinuation, switch, or interruption, the reason will be recorded)

  6. The change in creatinine clearance from baseline [ Time Frame: At month 3,6,9 and 12 ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with NVAF who have moderate (creatinine clearance 30 - 49 ml/min) or severe (creatinine clearance 15 - 29 ml/min) renal impairment, requiring rivaroxaban for the prevention of stroke or non-CNS systemic embolism. Patients must also meet all the eligibility criteria for the study.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746301


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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Korea, Republic of
Many locations Recruiting
Multiple Locations, Korea, Republic of
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03746301     History of Changes
Other Study ID Numbers: 20286
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Non-valvular Atrial fibrillation (NVAF), Stroke; Non-Central Nervous Systemic (CNS) embolism
Additional relevant MeSH terms:
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Atrial Fibrillation
Embolism
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Embolism and Thrombosis
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants