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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013472
Receipt No. 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

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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
Institute Kagawa Prefectural Central 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 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
URL(English) https://upload.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


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