UMIN ID: UMIN000006416
Registered date:30/09/2011
Preventive effects of Eicosapentaenoic acid (EPA) on stroke recurrence and a symptom state in chronic stroke patients with dyslipidemia.
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Chronic stroke patients with dyslipidemia |
Date of first enrollment | 2009/01/01 |
Target sample size | 100 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | pretreatment(Aspirin100mg/day) Eicosapentaenoic Acid ethyl ester 1800mg/day is added on pretreatment(Aspirin100mg/day) |
Outcome(s)
Primary Outcome | Endothelial function(FMD:Flow Mediated Dilation) |
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Secondary Outcome | 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) |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | 85years-old |
Gender | Male and Female |
Include criteria | |
Exclude 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 |
Related Information
Primary Sponsor | Tokyo Women's Medical University |
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Secondary Sponsor | |
Source(s) of Monetary Support | Tokyo Women's Medical University |
Secondary ID(s) |
Contact
public contact | |
Name | |
Address | Japan |
Telephone | 03-3353-8111 |
Affiliation | Tokyo Women's Medical University Department of Neuroiogy |
scientific contact | |
Name | Shinichiro Uchiyama |
Address | 8-1 Kawada-cho,Shinjyuku-ku,Tokyo Japan |
Telephone | |
Affiliation | Tokyo Women's Medical University Department of Neuroiogy |