UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016723 |
|---|---|
| Receipt number | 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 12:30:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
mdoimd@gmail.com
Sponsor or person
Institute
Kagawa Prefectural Central Hopital
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（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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019385
