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

NCT03247569 | Completed

• 1 other identifier: DU176b-C-A4011
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 6

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.

Conditions

Atrial Fibrillation

Keywords

Non-valvular Atrial Fibrillation; Real World Evidence; Observational Safety

Outcome Measures

Primary Outcomes (1)

• Number of participants with real world safety events

  2 years

Secondary Outcomes (3)

• Number of participants with patient relevant outcomes

  2 years

• Average duration of exposure to edoxaban

  within 2 years

• Number of participants compliant with edoxaban therapy

  2 years

Study Arms (1)

Edoxaban

Patients treated with Edoxaban

Drug: Edoxaban

Interventions

Edoxaban DRUG

Edoxaban according to Package Information (Summary of Product Characteristics (SmPC)).

Also known as: Lixiana

Edoxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Is participating in an interventional study

Sponsors & Collaborators

• Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company: lead

Study Sites (6)

Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast

Khon Kaen, Muang District, 40002, Thailand

Location

Bangkok Heart Hospital

Bangkok, Thailand

Location

Bhumibol Adulyadej Hospital

Bangkok, Thailand

Location

Bangkok Hospital Chiang Mai

Chiang Mai, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Thailand

Location

Thammasat University Hospital

Pathum Thani, Thailand

Location

Related Publications (2)

• Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.

  PMID: 24251359 BACKGROUND

• De Caterina R, Unverdorben M, Chen C, Choi EK, Koretsune Y, Morrone D, Pecen L, Bramlage P, Wang CC, Yamashita T, Kirchhof P. Two-Year Follow-Up of Patients With Atrial Fibrillation Receiving Edoxaban in Routine Clinical Practice: Results From the Global ETNA-AF Program. Clin Cardiol. 2025 Feb;48(3):e70091. doi: 10.1002/clc.70091.

  PMID: 40014354 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

edoxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Late Phase Operations Lead, Global Medical Affairs

  Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company

  STUDY DIRECTOR

• Study Project Manager

  Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 11, 2017
• Study Start: October 18, 2017
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

TH (6)