UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003947
Receipt No. R000004754
Scientific Title Evaluation of eicosapentaenoic acid (EPA) for preventing the progression of coronary atherosclerosis and revascularization in patients with dyslipidemia who underwent percutaneous coronary intervention (PCI)
Date of disclosure of the study information 2010/07/26
Last modified on 2010/07/28

* 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 Evaluation of eicosapentaenoic acid (EPA) for preventing the progression of coronary atherosclerosis and revascularization in patients with dyslipidemia who underwent percutaneous coronary intervention (PCI)
Acronym Evaluation of EPA for preventing the progression of coronary sclerosis and revascularization in post-PCI patients with dyslipidemia
Scientific Title Evaluation of eicosapentaenoic acid (EPA) for preventing the progression of coronary atherosclerosis and revascularization in patients with dyslipidemia who underwent percutaneous coronary intervention (PCI)
Scientific Title:Acronym Evaluation of EPA for preventing the progression of coronary sclerosis and revascularization in post-PCI patients with dyslipidemia
Region
Japan

Condition
Condition Coronary artery disease with dyslipidemia
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the prevention of progression of coronary atherosclerosis and coronary revascularization rate in non-PCI lesions and major adverse cardiovascular and cerebrovascular event (MACCE) in post-PCI patients with coronary artery diseases combining dyslipidemia by using strong statin alone or strong statin plus EPA
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes In non-PCI lesions with >= 50% stenosis according to the AHA classification,
1) change in MLD during the follow-up period
2) coronary revascularization
Key secondary outcomes MACCE:
death, nonfatal myocardial infarction, cerebral accident, unstable angina requiring hospitalization

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 strong statin alone
Interventions/Control_2 strong statin plus EPA 1800mg daily
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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Post-PCI patients with chronic coronary artery disease or acute coronary syndrome patients having >= 75% coronary artery stenosis according to the ACC/AHA classification
2) Patients with hypercholesterolemia taking strong statin or those meeting one of the dyslipidemia criteria: LDL-C >= 100mg/dl. TG >= 150mg/dl, HDL-C < 40mg/dl
3) Age: 20<=, < 75 years
4) Patients who can be followed up for longer than 18 months after PCI
5) Patients who have given written informed consent
Key exclusion criteria 1) Patients who have hypersensitivity to EPA
2) Patients who had cerebral accident in the past 6 months
3) Pregnant women and women suspected of being pregnant
4) Patients with gastrointestinal ulcer in active phase
5) Patients with bleeding
6) Patients who have very poor choleresis or severe liver dysfunction
7) Patients who are ineligible for this study
8) Patients with severe renal dysfunction or undergoing dialysis
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazusige Kadota
Organization Kurashiki central Hospital
Division name Department of Cardiology
Zip code
Address 1-1-1 Miwa, kurashik, Okayama 710-8602,Japan
TEL +81-86-422-0210
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Fuku
Organization Kurashiki central Hospital
Division name Department of Cardiology
Zip code
Address 1-1-1 Miwa, kurashik, Okayama 710-8602,
TEL +81-86-422-0210
Homepage URL
Email

Sponsor
Institute Kurashiki 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 倉敷中央病院(岡山県)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 26 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Open public recruiting
Date of protocol fixation
2010 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2013 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 07 Month 26 Day
Last modified on
2010 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004754

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.