Atrial Fibrillation Clinical Trial
Official title:
Non-interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Thailand)
Verified date | May 2022 |
Source | Daiichi Sankyo, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 300 |
Est. completion date | February 28, 2022 |
Est. primary completion date | February 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Bangkok Heart Hospital | Bangkok | |
Thailand | Bhumibol Adulyadej Hospital | Bangkok | |
Thailand | Bangkok Hospital Chiang Mai | Chiang Mai | |
Thailand | Maharaj Nakorn Chiang Mai Hospital | Chiang Mai | |
Thailand | Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast | Khon Kaen | Muang District |
Thailand | Thammasat University Hospital | Pathum Thani |
Lead Sponsor | Collaborator |
---|---|
Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company |
Thailand,
Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Špinar 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with real world safety events | 2 years | ||
Secondary | Number of participants with patient relevant outcomes | 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 years | |
Secondary | Average duration of exposure to edoxaban | within 2 years | ||
Secondary | Number of participants compliant with edoxaban therapy | 2 years |
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