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Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (NVAF)

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ClinicalTrials.gov Identifier: NCT03247569
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo (Thailand) 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 Thailand proposed this non-interventional study (NIS) to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other adverse events) of edoxaban use in non-preselected patients with NVAF.

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Edoxaban

Detailed Description:

Edoxaban was recently approved by The Thai Food and Drug Administration (Thai FDA) (date: 2nd December 2016) for the prevention of stroke and systemic embolism in adult patients with 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 Thailand proposed this non-interventional study (NIS) to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other adverse events) of edoxaban use in non-preselected patients with NVAF.

Real world evidence data of routine clinical practice use of edoxaban up to 2 years will be collected and evaluated in approximately 300 patients, treated by specialized as well as non-specialized physicians in hospital centres.


Study Type : Observational
Estimated Enrollment : 300 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-Thailand)
Actual Study Start Date : October 18, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Edoxaban
U.S. FDA Resources

Group/Cohort Intervention/treatment
Edoxaban
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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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): NCT03247569


Contacts
Contact: For Questions Concerning Enrollment +668 4645 6959 ajchareeya@peangpanya.com

Locations
Thailand
Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast Not yet recruiting
Khon Kaen, Muang District, Thailand, 40002
Principal Investigator: Assoc. Prof. Songsak Kiatchoosakun, MD         
Bangkok Heart Hospital Recruiting
Bangkok, Thailand
Bhumibol Adulyadej Hospital Recruiting
Bangkok, Thailand
Bangkok Hospital Chiang Mai Recruiting
Chiang Mai, Thailand
Maharaj Nakorn Chiang Mai Hospital Recruiting
Chiang Mai, Thailand
Thammasat University Hospital Recruiting
Pathum Thani, Thailand
Sponsors and Collaborators
Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company
Investigators
Study Director: Late Phase Operations Lead, Global Medical Affairs Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company
Study Chair: Study Project Manager Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company

Publications:
Responsible Party: Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company
ClinicalTrials.gov Identifier: NCT03247569     History of Changes
Other Study ID Numbers: DU176b-C-A4011
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
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 http://www.clinicalstudydatarequest.com. 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://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Studies for which the medicine and indication have received EU and US marketing approval on or after 01 January 2014 or by the US or EU Health Authorities when regulatory submissions in both 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 and the European Union 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://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx

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 (Thailand) Ltd., a Daiichi Sankyo Company ):
Non-valvular Atrial Fibrillation
Real World Evidence
Observational Safety

Additional relevant 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