UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013472
Receipt number R000015728
Scientific Title Clinical effect of early loading of eicosepentanoic acid for acute myocardial infarction: a prospective, open-labeled, randomized controlled clinical trial
Date of disclosure of the study information 2014/03/20
Last modified on 2017/09/05 12:30:51

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Basic information

Public title

Clinical effect of early loading of eicosepentanoic acid for acute myocardial infarction: a prospective, open-labeled, randomized controlled clinical trial

Acronym

Clinical effect of early loading of eicosepentanoic acid for acute myocardial infarction

Scientific Title

Clinical effect of early loading of eicosepentanoic acid for acute myocardial infarction: a prospective, open-labeled, randomized controlled clinical trial

Scientific Title:Acronym

Clinical effect of early loading of eicosepentanoic acid for acute myocardial infarction

Region

Japan


Condition

Condition

Acute myocardial infarction

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We examined whether eicosepentanoic acid (EPA) can reduce clinical adverse events by one month, accompanying by the decrease in C-reactive protein (CRP) value in patients with acute myocardial infarction

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary end point was composite clinical outcomes, including ventricular arrhythmias, paroxysmal atrial fibrillation, re-infarction, stroke and death.

Key secondary outcomes

Secondary end-point was peak CRP value after PCI, MI size estimated by peak creatine kinase (CK), and left ventricular ejection fraction at 2 weeks after onset of acute MI.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients received standard medication containing 2 mg/day of pitavastaitin as a control group.

Interventions/Control_2

Patients received additional 1,800 mg/day of eicosapentaenoic acid as a EPA group.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Acute myocardial infarction patients treated with percutaneous coronary intervention within 24 hours of symptom onset were eligible to study population. Myocardial infarction was diagnosed according to the Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction.

Key exclusion criteria

Exclusion criteria were cardiogenic shock, severe renal insufficiency requiring dialysis or continuous hemofiltration, cardiopulmonary arrest, emergent coronary artery bypass and failure of percutaneous coronary intervention

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masayuki Doi

Organization

Kagawa Prefectural Central Hospital

Division name

Cardiology

Zip code


Address

1-2-1 Asahi-machi, Takamatsu, Japan

TEL

087-811-3333

Email

mdoimd@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Masayuki Doi

Organization

Kagawa Prefectural Central Hospital

Division name

Cardiology

Zip code


Address

1-2-1 Asahi-machi, Takamatsu, Japan

TEL

087-811-3333

Homepage URL


Email

mdoimd@gmail.com


Sponsor or person

Institute

Kagawa Prefectural Central 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

香川県立中央病院(香川県)


Other administrative information

Date of disclosure of the study information

2014 Year 03 Month 20 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2010 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 10 Month 01 Day

Last follow-up date

2013 Year 03 Month 31 Day

Date of closure to data entry

2013 Year 03 Month 31 Day

Date trial data considered complete

2013 Year 08 Month 31 Day

Date analysis concluded

2013 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2014 Year 03 Month 20 Day

Last modified on

2017 Year 09 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015728


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name