UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007956 |
|---|---|
| Receipt number | R000009367 |
| Scientific Title | Effect of Eicosapentaenoic acid on adequate statin therapy in patients with coronary artery disease. Prospective randomized trial. |
| Date of disclosure of the study information | 2012/05/21 |
| Last modified on | 2014/07/01 08:47:12 |
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Basic information
Public title
Effect of Eicosapentaenoic acid on adequate statin therapy in patients with coronary artery disease.
Prospective randomized trial.
Acronym
Effect of Eicosapentaenoic acid on adequate statin therapy in patients with coronary artery disease.
Scientific Title
Effect of Eicosapentaenoic acid on adequate statin therapy in patients with coronary artery disease.
Prospective randomized trial.
Scientific Title:Acronym
Effect of Eicosapentaenoic acid on adequate statin therapy in patients with coronary artery disease.
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of Eicosapentaenoic acid on endothelial function in coronary artery disease patients under adequate statin therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in flow mediated dilation.
Key secondary outcomes
Change in Lipid profiles.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
Add oral EPA 1800 mg daily on the ordinary statin treatment.
Interventions/Control_2
Ordinary statin treatment.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were;
1. Patients with established coronary artery disease.
2. ALL patients received adequate statin treatment and LDL-Cholesterol was controlled less than 100 mg/dl.
3. Patients had endothelial dysfunction defined as FMD <6%.
Key exclusion criteria
The exclusion criteria were;
1. Episode of acute coronary syndrome or revascularization within 3 months.
2. Initiation of ACE-I, ARB, CCB, beta-blockers, antiplatelet drugs, or other lipid-lowering drugs within 3 months.
3. Severe renal and liver dysfunction
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Nishioka |
Organization
Saitama medical center, Saitama medical University
Division name
Division of cardiology
Zip code
Address
1981 Kamoda, Kawagoe city, Saitama, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Toyama |
Organization
Saitama medical center, Saitama medical university
Division name
Division of cardiology
Zip code
Address
1981 Kamoda, Kawagoe city, Saitama, Japan
TEL
Homepage URL
Sponsor or person
Institute
Saitama medical center, Saitama medical university
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 21 | 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
| 2012 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | 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
| 2012 | Year | 05 | Month | 15 | Day |
Last modified on
| 2014 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009367
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
