Protective Effect of EPA on Cardiovascular Events

Myocardial Infarction, Unstable Angina Pectoris, Sudden Cardiac Death, Stroke, Peripheral Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231738
• Other study ID #: MYokoyama - 001
• Status: Completed
• Phase: Phase 4
• First received: October 3, 2005
• Last updated: November 19, 2015
• Start date: November 1996
• Est. completion date: November 2004

Study information

• Verified date: October 2005
• Source: Kobe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18000
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Unstable
• Death, Sudden, Cardiac
• Myocardial Infarction
• Myocardial Infarction, Unstable Angina Pectoris, Sudden Cardiac Death, Stroke, Peripheral Artery Disease
• Peripheral Arterial Disease

Intervention

Drug:
• Eicosapentaenoic acid ethyl ester(EPADEL Capsule 300 TM)

Locations

Country	Name	City	State
Japan	Kobe University Graduate School of Medicine Cardiovascular and Respiratory Medicine Division, Department of Internal Medicine	Kobe	Hyogo-prefecture

Sponsors (2)

Lead Sponsor	Collaborator
Kobe University	Mochida Pharmaceutical Company, Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Yokoyama M, Origasa H; JELIS Investigators. Effects of eicosapentaenoic acid on cardiovascular events in Japanese patients with hypercholesterolemia: rationale, design, and baseline characteristics of the Japan EPA Lipid Intervention Study (JELIS). Am Heart J. 2003 Oct;146(4):613-20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All-cause mortality
Secondary	Stroke
Secondary	Peripheral artery disease; and
Secondary	Cancer