UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002653 |
|---|---|
| Receipt number | R000003231 |
| Scientific Title | A study on the effects of eicosapentaenoic acid (EPA) on arteriosclerosis in hemodialysis patients with percutaneous coronary intervention (PCI) |
| Date of disclosure of the study information | 2009/11/01 |
| Last modified on | 2024/05/02 09:48:08 |
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Basic information
Public title
A study on the effects of eicosapentaenoic acid (EPA) on arteriosclerosis in hemodialysis patients with percutaneous coronary intervention (PCI)
Acronym
A study on the effects of eicosapentaenoic acid (EPA) on arteriosclerosis in hemodialysis patients with percutaneous coronary intervention (PCI)
Scientific Title
A study on the effects of eicosapentaenoic acid (EPA) on arteriosclerosis in hemodialysis patients with percutaneous coronary intervention (PCI)
Scientific Title:Acronym
A study on the effects of eicosapentaenoic acid (EPA) on arteriosclerosis in hemodialysis patients with percutaneous coronary intervention (PCI)
Region
| Japan |
Condition
Condition
Dialysis patients who have been subjected to PCI.
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the current study is to evaluate the efficacy of EPA, which has been proven to prevent the development of coronary events in non-specific patient population with dyslipidemia, in those undergoing hemodialysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Restenosis rate one year after the treatment
TVR one year after the treatment
MACE [death, non-fatal myocardial infarction, stroke, revascularization (endovascular treatment or bypass surgery)]
Key secondary outcomes
Improvement in IMT and CAVI as seen in comparison with before and after EPA administration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Patients treated with eicosapentaenoic acid (EPA), who were treated with 1800 mg/day of a highly purified EPA preparation in addition to conventional therapy.
Interventions/Control_2
Conventional therapy.
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) Dialysis patients who exhibited stenosis in excess of 75%, involving 1 to 2 branches noted by means such as coronary angiography and have stenting by using percutaneous coronary intervention (PCI).
2) Over 20 and under 75 years of age.
3) Available for a 12-month follow-up after PCI.
4) Have given their consent in written form.
Key exclusion criteria
1) A history of hypersensitivity to highly purified EPA preparations.
2) Have had the onset of stroke within the past 6 months.
3) Left ventricular ejection fraction below 40%.
4) Are currently pregnant or may be pregnant.
5) Suffering from hemorrhage (e.g., hemophilia, capillary fragility, gastrointestinal hemorrhage, urinary tract hemorrhage, hemoptysis and vitreous hemorrhage).
6) A peptic ulcer.
7) Extremely poor bile secretion or severe hepatic dysfunction.
8) Others judged to be inappropriate to participate in the current study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Kamoi |
Organization
Nagoya Kyoritsu Hospital
Division name
Department of Cardiology
Zip code
4540933
Address
1-172 Hokke Nakagawa-ku, Nagoya,
TEL
0523625151
dkamoi.dk77@gmail.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kamoi |
Organization
Nagoya Kyoritsu Hospital
Division name
Department of Cardiology
Zip code
4540933
Address
1-172 Hokke Nakagawa-ku, Nagoya
TEL
0523625151
Homepage URL
dkamoi.dk77@gmail.com
Sponsor or person
Institute
Nagoya Kyoritsu Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya Kyoritsu Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Cardiology, Nagoya University Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya Kyoritsu Hospital
Address
1-172, Hokke, Nakagawa-ku, Nagoya
Tel
052-362-5151
dkamoi@kaikou.or.jp
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
| 2009 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000003231
Publication of results
Partially published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000003231
Number of participants that the trial has enrolled
50
Results
Low ratios of both EPA/AA ratio and n-3/n-6 PUFAs were closely associated with carotid atherosclerosis in patients on HD.
Results date posted
| 2024 | Year | 05 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1) Dialysis patients who exhibited stenosis in excess of 75%, involving 1 to 2 branches noted by means such as coronary angiography and have stenting by using percutaneous coronary intervention (PCI).
2) Over 20 and under 75 years of age.
3) Available for a 12-month follow-up after PCI.
4) Have given their consent in written form.
Participant flow
Patients treated with eicosapentaenoic acid (EPA), who were treated with 1800 mg/day of a highly purified EPA preparation in addition to conventional therapy.
Adverse events
None
Outcome measures
Restenosis rate one year after the treatment
TVR one year after the treatment
MACE [death, non-fatal myocardial infarction, stroke, revascularization (endovascular treatment or bypass surgery)]
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2009 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2009 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 21 | Day |
Last modified on
| 2024 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003231
