UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004209
Receipt number 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 15:15:18

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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 or person

Institute

Hiroshima university hospital

Institute

Department

Personal name



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

Value
https://center6.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