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Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment (XAIENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096547
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Young Keun On, Samsung Medical Center

Brief Summary:

Study Type and Design Prospective, Observational Study Rivaroxaban in Elderly AF patients with or without renal impairment in Korea

This study will investigate effectiveness and safety in elderly patients, the result from well-designed and high-quality prospective clinical registry collected through real-world clinical practice is expected to resolve current medical unmet needs of rivaroxaban in Korean elderly patients.

Primary Study Objective(s) To investigate the effectiveness of rivaroxaban in elderly patients with NVAF, with or without renal impairment in Korea real-world clinical practice settings Secondary Study Objective(s) To see safety outcome including major bleeding, clinically non-major bleeding, all-cause mortality rivaroxaban in subgroup based on risk factor(eg. Renal impairment) physicians' treatment pattern in rivaroxaban


Condition or disease Intervention/treatment
Atrial Fibrillation Rivaroxaban Elderly Renal Insufficiency Drug: Rivaroxaban

Detailed Description:
Study Population Elderly patients with age ≥ 65 years with treatment naïve or treatment-experienced patients who are diagnosed with NVAF Expected number of patient enrollment is about 1200 patients, Samsung Medical Center is aim to enroll about 200 patients

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-interventional, Multicenter Observational Study to Evaluate the Effectiveness and Safety of Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment
Estimated Study Start Date : September 25, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban


Intervention Details:
  • Drug: Rivaroxaban
    rivaroxaban for stroke prevention of atrial fibrillation


Primary Outcome Measures :
  1. Composite incidence of stroke/ non-CNS SE [ Time Frame: 1 year ]
    incidence of stroke/ non-CNS SE


Secondary Outcome Measures :
  1. Bleeding incidence [ Time Frame: 1 year ]
    Bleeding incidence


Other Outcome Measures:
  1. renal function [ Time Frame: 1 year ]
    CCl



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Elderly patients with age ≥ 65 years with treatment naïve or treatment-experienced patients who are diagnosed with NVAF Expected number of patient enrollment is about 1200 patients,
Criteria

Inclusion Criteria:

  1. Patients with consent given
  2. Elderly patients with age 65 ≥ years old
  3. NVAF patients first time prescription to rivaroxaban or patients who started rivaroxaban treatment within 3 months

Exclusion Criteria:

  1. Refusal to participate in this study or to give an informed consent
  2. Patients with moderate to severe mitral stenosis
  3. Patients with mechanical valve
  4. Contraindication from rivaroxaban Korea SmPC
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Responsible Party: Young Keun On, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT04096547    
Other Study ID Numbers: IRB 2019-06-078
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Kidney Diseases
Urologic Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants