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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004209
Receipt No. R000004437
Scientific Title Randomized, parallel group, controlled trial of EPA for the prevention of atrial fibrillation following coronary artery bypass surgery
Date of disclosure of the study information 2010/09/15
Last modified on 2019/04/17

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Basic information
Public title Randomized, parallel group, controlled trial of EPA for the prevention of atrial fibrillation following coronary artery bypass surgery
Acronym Preventive effect of EPA against atrial fibrillation following coronary artery bypass surgery
Scientific Title Randomized, parallel group, controlled trial of EPA for the prevention of atrial fibrillation following coronary artery bypass surgery
Scientific Title:Acronym Preventive effect of EPA against atrial fibrillation following coronary artery bypass surgery
Region
Japan

Condition
Condition Atrial fibrillation
Coronary artery bypass surgery
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess the efficacy of EPA in preventing the occurrence of atrial fibrillation following coronary artery bypass surgery in open-labeled, parallel group, controlled study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Incidence of atrial fibrillation during the postoperative hospitalization.
Key secondary outcomes Correlation between occurrence of atrial fibrillation and serum EPA/AA.
Adverse events of EPA.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 usual care plus EPA
Interventions/Control_2 usual care
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Elective coronary artery bypass surgery
Hyperlipidemia
Older than 20 years and younger than 80 years of age
Key exclusion criteria Prior history of atrial fibrillation
Prior history of valvular surgery
Prior history of EPA side effect
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taijiro Sueda
Organization Hiroshima university hospital
Division name Department of cardiovascular surgery
Zip code
Address 2-3, Ksumi 1-chome, Minami-Ku, Hiroshima, JAPAN, 734-8551
TEL 082-257-5216
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsuhiko Imai
Organization Hiroshima university hospital
Division name Department of cardiovascular surgery
Zip code
Address 2-3, Ksumi 1-chome, Minami-Ku, Hiroshima, JAPAN, 734-8551
TEL 082-257-5216
Homepage URL
Email

Sponsor
Institute Hiroshima university hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2010 Year 05 Month 31 Day
Date of IRB
2010 Year 08 Month 03 Day
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 15 Day
Last modified on
2019 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004437

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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