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
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
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
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
