Protective Effect of EPA on Cardiovascular Events

This study has been completed.
Sponsor:
Collaborator:
Mochida Pharmaceutical Company, Ltd.
Information provided by:
Kobe University
ClinicalTrials.gov Identifier:
NCT00231738
First received: October 3, 2005
Last updated: NA
Last verified: October 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction, Unstable Angina Pectoris, Sudden Cardiac Death, Stroke, Peripheral Artery Disease
Drug: Eicosapentaenoic acid ethyl ester(EPADEL Capsule 300 TM)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Eicosapentaenoic Acid (EPA) on Major Cardiovascular Events in Hypercholesterolemic Patients: the Japan EPA Lipid Intervention Study (JELIS)

Resource links provided by NLM:


Further study details as provided by Kobe University:

Primary Outcome Measures:
  • 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:
  • All-cause mortality
  • Stroke
  • Peripheral artery disease; and
  • Cancer

Estimated Enrollment: 18000
Study Start Date: November 1996
Estimated Study Completion Date: November 2004
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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231738

Locations
Japan
Kobe University Graduate School of Medicine Cardiovascular and Respiratory Medicine Division, Department of Internal Medicine
Kobe, Hyogo-prefecture, Japan, 650-0017
Sponsors and Collaborators
Kobe University
Mochida Pharmaceutical Company, Ltd.
Investigators
Principal Investigator: Mitsuhiro Yokoyama, MD, PhD.
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00231738     History of Changes
Other Study ID Numbers: No
Study First Received: October 3, 2005
Last Updated: October 3, 2005
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kobe University:
Eicosapentaenoic acid
Coronary artery disease

Additional relevant MeSH terms:
Angina Pectoris
Angina, Unstable
Infarction
Myocardial Infarction
Death, Sudden, Cardiac
Death
Peripheral Arterial Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis
Heart Arrest
Death, Sudden
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Peripheral Vascular Diseases
Eicosapentaenoic acid ethyl ester
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014