Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong)

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: NCT03247582
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Hong Kong Ltd., a Daiichi Sankyo Company )

Brief Summary:
In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the NVAF indication, Daiichi-Sankyo Hong Kong proposed this non-interventional study (NIS) to gain insight into the safety of edoxaban use in non-preselected patients with NVAF.

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Edoxaban

Detailed Description:

Edoxaban was approved by the Pharmacy and Poisons Board in Hong Kong (date: 31 May 2016) for the: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the NVAF indication, Daiichi-Sankyo proposed this non-interventional study (NIS) to gain insight into the safety of edoxaban use in non-preselected patients with NVAF.

Real world evidence from routine clinical practice using edoxaban up to 2 years will be collected and evaluated in approximately 200 patients, treated by specialized as well as non-specialized physicians in hospital centers.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong)
Actual Study Start Date : August 2, 2017
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Edoxaban

Group/Cohort Intervention/treatment
Edoxaban
NVAF Patients treated with Edoxaban
Drug: Edoxaban
Edoxaban according to Package Information (Summary of Product Characteristics (SmPC)).
Other Name: Lixiana




Primary Outcome Measures :
  1. Number of participants with real world safety events [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Number of participants with patient relevant outcomes [ Time Frame: 2 years ]
    Categories: Strokes (ischaemic and haemorrhagic), Systemic Embolic Events (SEE), Transient Ischemic Attack (TIA), Major Adverse Cardiovascular Events (MACE), Venous Thromboembolism (VTE), Acute Coronary Syndrome (ACS), Hospitalisations related to cardiovascular (CV) condition

  2. Average duration of exposure to edoxaban [ Time Frame: within 2 years ]
  3. Number of participants compliant with edoxaban therapy [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary strategy is to include only patients with NVAF who are to be treated with edoxaban according to Package Information (Summary of Product Characteristics (SmPC)). To ensure that the physician's prescribing behaviour will not be influenced, patients may only be included after the treating physician has made the clinical decision to prescribe edoxaban. Patients must have provided written informed consent for participation in the study (ICF) and should not participate simultaneously in any interventional study.
Criteria

Inclusion Criteria:

  • Is a NVAF-patient whose physician has made the clinical decision to prescribe edoxaban therapy according to Package Information
  • Has provided written informed consent to participate in the study

Exclusion Criteria:

  • Is participating in an interventional study

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): NCT03247582


Contacts
Layout table for location contacts
Contact: For Questions Concerning Enrollment +852 (3519) 4308 Tammy.Cheng@PAREXEL.com

Locations
Layout table for location information
Hong Kong
Prince of Wales Hospital (1082) Recruiting
Hong Kong, Hong Kong
Prince of Wales Hospital (1083) Recruiting
Hong Kong, Hong Kong
Queen Mary Hospital, Department of Cardiology (1801) Recruiting
Hong Kong, Hong Kong
Queen Mary Hospital, Department of Neurology (1805) Recruiting
Hong Kong, Hong Kong
Sponsors and Collaborators
Daiichi Sankyo Hong Kong Ltd., a Daiichi Sankyo Company
Investigators
Layout table for investigator information
Study Director: Late Phase Operations Lead, Global Medical Affairs Daiichi Sankyo, Inc.
Study Chair: Study Project Manager Daiichi Sankyo (Hong Kong), Ltd.

Publications:
Layout table for additonal information
Responsible Party: Daiichi Sankyo Hong Kong Ltd., a Daiichi Sankyo Company
ClinicalTrials.gov Identifier: NCT03247582     History of Changes
Other Study ID Numbers: DU176b-C-A4012
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Hong Kong Ltd., a Daiichi Sankyo Company ):
Real World Evidence
Non-valvular Atrial Fibrillation
Observational Safety
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Edoxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants