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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002653
Receipt No. 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 2017/04/27

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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
Middle name
Last name Daisuke Kamoi
Organization Nagoya Kyoritsu Hospital
Division name Department of Cardiology
Zip code
Address 1-172 Hokke Nakagawa-ku, Nagoya,
TEL 0523625151
Email dkamoi.dk77@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Kamoi
Organization Nagoya Kyoritsu Hospital
Division name Department of Cardiology
Zip code
Address 1-172 Hokke Nakagawa-ku, Nagoya
TEL 0523625151
Homepage URL
Email dkamoi.dk77@gmail.com

Sponsor
Institute Nagoya Kyoritsu Hospital
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 01 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
2009 Year 10 Month 21 Day
Date of IRB
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 10 Month 21 Day
Last modified on
2017 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003231

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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