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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016723
Receipt No. R000019385
Scientific Title Clinical effect of early loading of eicosepentaenoic acid after percutaneous coronary intervention in patients with acute coronary syndrome: a prospective, open-labeled, randomized controlled clinical trial
Date of disclosure of the study information 2015/04/01
Last modified on 2017/09/05

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Basic information
Public title Clinical effect of early loading of eicosepentaenoic acid after percutaneous coronary intervention in patients with acute coronary syndrome: a prospective, open-labeled, randomized controlled clinical trial
Acronym Clinical effect of early loading of eicosepentaenoic acid after percutaneous coronary intervention in patients with acute coronary syndrome: a prospective, open-labeled, randomized controlled clinical trial
Scientific Title Clinical effect of early loading of eicosepentaenoic acid after percutaneous coronary intervention in patients with acute coronary syndrome: a prospective, open-labeled, randomized controlled clinical trial
Scientific Title:Acronym Clinical effect of early loading of eicosepentaenoic acid after percutaneous coronary intervention in patients with acute coronary syndrome: a prospective, open-labeled, randomized controlled clinical trial
Region
Japan

Condition
Condition Acute coronary syndrome
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine whether early loading of eicosepentaenoic acid (EPA) after coronary intervention can reduce cardiovascular events for one year in patients with acute coronary syndrome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes cardiovascular death, non-fatal myocardial infarction, stroke, and intervention for de novo coronary lesions.
Key secondary outcomes Heart failure hospitalization

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 receive standard medication containing 2 mg/day of pitavastatin as the control group.
Interventions/Control_2 Patients receive 1800 mg/day of eicosapentaenoic acid in addition to standard medication containing 2 mg/day of pitavastatin as the 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 coronary syndrome patients treated with successful percutaneous coronary intervention within 24 hours
Key exclusion criteria cardiogenic shock, severe renal insufficiency requiring dialysis or continuous hemofiltration, cardiopulumonary arrest, emergency coronary artery bypass and failure of percutaneous coronary intervention.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Doi
Organization Kagawa Prefectural Central Hopital
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 Hopital
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 Hopital
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(Kagawa Prefectural Central Hospital)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 01 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
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 06 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=R000019385

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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