Non-interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Thailand)

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



Sponsors


Source

Daiichi Sankyo, Inc.

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No

Is Us Export

No


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.

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.

Overall Status

Not yet recruiting

Start Date

2017-08-01

Completion Date

2021-09-01

Primary Completion Date

2021-08-01

Phase

N/A

Study Type

Observational

Primary Outcome

Measure

Time Frame

Number of participants with real world safety events
2 years

Secondary Outcome

Measure

Time Frame

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

Number Of Groups

1

Enrollment

300

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

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

Arm Group Label

Edoxaban

Other Name

Lixiana


Eligibility

Study Pop

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.

Sampling Method

Non-Probability Sample

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

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Late Phase Operations Lead, Global Medical Affairs
Study Director
Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company
Study Project Manager
Study Chair
Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company

Overall Contact

Last Name

For Questions Concerning Enrollment

Phone

+668 4645 6959

Email

[email protected]


Location

Facility

Status

Investigator

Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast
Khon Kaen Muang District 40002 Thailand
Not yet recruiting
Last Name: Assoc. Prof. Songsak Kiatchoosakun, MD
Role: Principal Investigator

Location Countries

Country

Thailand


Verification Date

2017-08-01

Lastchanged Date

2017-08-09

Firstreceived Date

2017-08-09

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Condition Browse


Intervention Browse

Mesh Term

Edoxaban


Arm Group

Arm Group Label

Edoxaban

Description

Patients treated with Edoxaban


Firstreceived Results Date

N/A

Reference

Citation

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.

PMID

24251359


Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Cohort

Time Perspective

Prospective



ClinicalTrials.gov processed this data on August 11, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



© 2017 ICH GCP