UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003947 |
|---|---|
| Receipt number | 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 10:51:35 |
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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
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
Sponsor or person
Institute
Kurashiki 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004754
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