UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006416 |
|---|---|
| Receipt number | R000007527 |
| Scientific Title | Preventive effects of Eicosapentaenoic acid (EPA) on stroke recurrence and a symptom state in chronic stroke patients with dyslipidemia. |
| Date of disclosure of the study information | 2011/09/30 |
| Last modified on | 2011/09/27 15:49:55 |
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Basic information
Public title
Preventive effects of Eicosapentaenoic acid (EPA) on stroke recurrence and a symptom state in chronic stroke patients with dyslipidemia.
Acronym
Preventive effects of Eicosapentaenoic acid (EPA) on stroke recurrence and a symptom state in chronic stroke patients with dyslipidemia.
Scientific Title
Preventive effects of Eicosapentaenoic acid (EPA) on stroke recurrence and a symptom state in chronic stroke patients with dyslipidemia.
Scientific Title:Acronym
Preventive effects of Eicosapentaenoic acid (EPA) on stroke recurrence and a symptom state in chronic stroke patients with dyslipidemia.
Region
| Japan |
Condition
Condition
Chronic stroke patients with dyslipidemia
Classification by specialty
| Medicine in general | Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is to evaluate the safety and efficacy of EPA treatment for chronic stroke patients with dyslipidemia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endothelial function(FMD:Flow Mediated Dilation)
Key secondary outcomes
1.IMT(intima Media Thickness)
2.Endothelial function(ADMA:Asymmetric Dimethyl Arginine)
3.Inflammatory markers(hs-CRP:High sensitivity C-reactive protein)
4.Adiponectin
5.Serum lipid(TC,HDL-C,TG)
6.Plasma fatty acid(EPA/AA ratios)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pretreatment(Aspirin100mg/day)
Interventions/Control_2
Eicosapentaenoic Acid ethyl ester 1800mg/day is added on pretreatment(Aspirin100mg/day)
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Chronic stroke patients with dyslipidemia fulfilled following conditions at baseline will be enrolled
(targeted)
1. Stroke (Chronic athero thrombotic brain infarction, lacunar infarction or asymptomatic cerebral infarction identified by CT or MRI) onset over 6 months prior to study enrollment
2.Hyperlipidemia(especially high TG/low HDL-C) patients with well-defined
3.Written informed consent for this study is obtained
Key exclusion criteria
Following patients will be excluded from this study
1.SBP>=180mmHg or DBP>=110
2.Patirnts who are bleeding (Hemophilia, intracranial bleeding, Gastrointestinal bleeding, Urinary tract bleeding, Hemophysis, Vitreous hemorrhage)
3.Patients with known bleeding disorders or a predisposing condition
4.Severe liver or renal dysfunction
5.Malignancy
6.Scheduling the operation
7.Past history of severe adverse effect by Aspirin or Eicosapentaenoic Acid ethyl ester
8.Patients who are inadequate by physician's decision
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Uchiyama |
Organization
Tokyo Women's Medical University
Division name
Department of Neuroiogy
Zip code
Address
8-1 Kawada-cho,Shinjyuku-ku,Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Women's Medical University
Division name
Department of Neuroiogy
Zip code
Address
TEL
03-3353-8111
Homepage URL
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
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
| 2011 | Year | 09 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2008 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | 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
| 2011 | Year | 09 | Month | 27 | Day |
Last modified on
| 2011 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007527
| 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 |
