Protective Effect of EPA on Cardiovascular Events

November 19, 2015 updated by: Kobe University

Effect of Eicosapentaenoic Acid (EPA) on Major Cardiovascular Events in Hypercholesterolemic Patients: the Japan EPA Lipid Intervention Study (JELIS)

The purpose of this study was to test the hypothesis that the long-term use of highly (>98%) purified EPA, in addition to HMG-CoA reductase inhibitor (statin), would be more effective than statin alone in preventing cardiovascular events in Japanese patients with hypercholesterolemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Epidemiological studies from many countries including Finland, Italy, Japan, and The Netherlands have suggested that an increased intake of dietary fish or fish oil rich in the long-chain polyunsaturated n-3 fatty acids (PUFAs), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), is inversely related to the risk of atherothrombotic diseases, in particular coronary artery disease (CAD).

Results of many prospective observational cohort studies have found that diets rich in marine PUFAs may be protective against major cardiovascular events, including mortality from CAD, total cardiovascular death, all-cause mortality, and nonfatal myocardial infarction. To date, only a few studies have examined the effects of purified n-3 PUFA preparations in human subjects for short observation periods. The principle aim of the current study is to test the hypothesis that the long-term use of highly purified EPA(eicosapentaenoic acid: 1800mg/day), in addition to HMG-CoA reductase inhibitor, is effective in preventing cardiovascular events in Japanese patients with hypercholesterolemia.

Study Type

Interventional

Enrollment

18000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hyogo-prefecture
      • Kobe, Hyogo-prefecture, Japan, 650-0017
        • Kobe University Graduate School of Medicine Cardiovascular and Respiratory Medicine Division, Department of Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eligible participants had a total cholesterol level of ≧250mg/dL(6.5m mol/L) at baseline.
  • Hyperlipidemic patients with serum total cholesterol of 250mg/dL or more. (Measurement of serum total cholesterol)
  • Serum total cholesterol should be measured twice at interval of 2-4weeks. A single measurement is acceptable if the cholesterol is measured by blood collection at fasting under strict compliance with dietary advice after withdrawal of the antihyperlipemic drug.
  • (Wash Out) The wash out period of 4weeks (8 weeks for probucol) is necessary in patients under treatment with antihyperlipemic drug. However, if treatment with the antihyperlipemic drug was started within 6 months of the initiation of the study, the patient can participate in the study without the washout period.

Exclusion Criteria:

  • Acute myocardial infarction occurring within last 6 months
  • Unstable angina pectoris
  • A history or complication of serious heart disease(severe arrhythmia, heart failure, cardiac myopathy, valvular disease, congenital disease, etc.)
  • Receiving cardiovascular reconstruction within last 6 months
  • Cerebrovascular disorders occurring within last 6 months
  • Complication of serious hepatic disease or renal disease
  • Malignant tumor
  • Uncontrollable diabetes
  • Hyperlipidemia arising from the following disease: Nephrotic syndrome, hypothyroidism, Cushing's syndrome, secondary hyperlipidemia due to other disease
  • Hyperlipidemia due to some drugs such as steroid hormone
  • Hemorrhage(hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage, etc.)
  • Hemorrhagic diathesis
  • Hypersensitivity to the study drug formulation
  • Patients intending to undergo surgery
  • Patients judged to be inappropriate by the physician in charge

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Major coronary events (sudden cardiac death, fatal and nonfatal myocardial infarction, unstable angina pectoris including hospitalization for ischemic episodes,events of angioplasty/ stenting or coronary artery bypass grafting)

Secondary Outcome Measures

Outcome Measure
Stroke
Cancer
All-cause mortality
Peripheral artery disease; and

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kobe University

Collaborators

Mochida Pharmaceutical Company, Ltd.

Investigators

  • Principal Investigator: Mitsuhiro Yokoyama, MD, PhD.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1996

Study Completion

November 1, 2004

Study Registration Dates

First Submitted

October 3, 2005

First Submitted That Met QC Criteria

October 3, 2005

First Posted (Estimate)

October 4, 2005

Study Record Updates

Last Update Posted (Estimate)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 19, 2015

Last Verified

October 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MYokoyama - 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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