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Effect of polysaturated fatty acids on vascular healing process in hyper-cholesterolemic patients with acute coronary syndrome

Not Applicable
Conditions
acute coronary syndrome
Registration Number
JPRN-UMIN000012825
Lead Sponsor
Department of Cardiovascular Medicine Nara Medical University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
180
Inclusion Criteria

Not provided

Exclusion Criteria

Patients meeting all of the following criteria will be excluded. 1) patients who had been taking EPA or EPA+DHA before enrollment 2) bleeding tendency 3) hypersensitivity for EPA or EPA+DHA 4) congestive heart failure 5) refractory unstable angina 6) participating other clinical trials 7) pregnant, lactating, and possibly pregnant women and those planning to become pregnant 8) judged as ineligible by clinical investigators

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes in OCT parameter at 8-month follow-up 1) thickness of fibrous cap at non-culprit lipid rich plaque 2) condition of neointimal coverage over implanted stent
Secondary Outcome Measures
NameTimeMethod
Changes in following paremter at 8-month follow-up 1) lipid core size (OCT) 2) serum plasma profile 3) changes in inflammatory parameters 4) relation between lipid core size and serum lipid profile Changes in following paremter at 12-month follow-up 5) serum lipid profile 6) development of adverse cardiovascular events
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