Protective Effect of EPA on Cardiovascular Events

NCT00231738 | Completed Phase 4

• 1 other identifier: MYokoyama - 001
• Study Type: interventional
• Target: 18,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Eicosapentaenoic acid; Coronary artery disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• All-cause mortality

• Stroke

• Peripheral artery disease; and

• Cancer

Interventions

Eicosapentaenoic acid ethyl ester(EPADEL Capsule 300 TM) DRUG

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kobe University: lead
• Mochida Pharmaceutical Company, Ltd.: collaborator

Study Sites (1)

Kobe University Graduate School of Medicine Cardiovascular and Respiratory Medicine Division, Department of Internal Medicine

Kobe, Hyōgo, 650-0017, Japan

Location

Related Publications (8)

• 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. doi: 10.1016/S0002-8703(03)00367-3.

  PMID: 14564313 BACKGROUND

• Ishikawa Y, Yokoyama M, Saito Y, Matsuzaki M, Origasa H, Oikawa S, Sasaki J, Hishida H, Itakura H, Kita T, Kitabatake A, Nakaya N, Sakata T, Shimada K, Shirato K, Matsuzawa Y; JELIS Investigators. Preventive effects of eicosapentaenoic acid on coronary artery disease in patients with peripheral artery disease. Circ J. 2010 Jul;74(7):1451-7. doi: 10.1253/circj.cj-09-0520. Epub 2010 May 18.

  PMID: 20484828 DERIVED

• Origasa H, Yokoyama M, Matsuzaki M, Saito Y, Matsuzawa Y; JELIS Investigators. Clinical importance of adherence to treatment with eicosapentaenoic acid by patients with hypercholesterolemia. Circ J. 2010 Mar;74(3):510-7. doi: 10.1253/circj.cj-09-0746. Epub 2010 Feb 9.

  PMID: 20145342 DERIVED

• Oikawa S, Yokoyama M, Origasa H, Matsuzaki M, Matsuzawa Y, Saito Y, Ishikawa Y, Sasaki J, Hishida H, Itakura H, Kita T, Kitabatake A, Nakaya N, Sakata T, Shimada K, Shirato K; JELIS Investigators, Japan. Suppressive effect of EPA on the incidence of coronary events in hypercholesterolemia with impaired glucose metabolism: Sub-analysis of the Japan EPA Lipid Intervention Study (JELIS). Atherosclerosis. 2009 Oct;206(2):535-9. doi: 10.1016/j.atherosclerosis.2009.03.029. Epub 2009 Apr 5.

  PMID: 19447387 DERIVED

• Matsuzaki M, Yokoyama M, Saito Y, Origasa H, Ishikawa Y, Oikawa S, Sasaki J, Hishida H, Itakura H, Kita T, Kitabatake A, Nakaya N, Sakata T, Shimada K, Shirato K, Matsuzawa Y; JELIS Investigators. Incremental effects of eicosapentaenoic acid on cardiovascular events in statin-treated patients with coronary artery disease. Circ J. 2009 Jul;73(7):1283-90. doi: 10.1253/circj.cj-08-1197. Epub 2009 May 8.

  PMID: 19423946 DERIVED

• Saito Y, Yokoyama M, Origasa H, Matsuzaki M, Matsuzawa Y, Ishikawa Y, Oikawa S, Sasaki J, Hishida H, Itakura H, Kita T, Kitabatake A, Nakaya N, Sakata T, Shimada K, Shirato K; JELIS Investigators, Japan. Effects of EPA on coronary artery disease in hypercholesterolemic patients with multiple risk factors: sub-analysis of primary prevention cases from the Japan EPA Lipid Intervention Study (JELIS). Atherosclerosis. 2008 Sep;200(1):135-40. doi: 10.1016/j.atherosclerosis.2008.06.003. Epub 2008 Jun 19.

  PMID: 18667204 DERIVED

• Tanaka K, Ishikawa Y, Yokoyama M, Origasa H, Matsuzaki M, Saito Y, Matsuzawa Y, Sasaki J, Oikawa S, Hishida H, Itakura H, Kita T, Kitabatake A, Nakaya N, Sakata T, Shimada K, Shirato K; JELIS Investigators, Japan. Reduction in the recurrence of stroke by eicosapentaenoic acid for hypercholesterolemic patients: subanalysis of the JELIS trial. Stroke. 2008 Jul;39(7):2052-8. doi: 10.1161/STROKEAHA.107.509455. Epub 2008 May 1.

  PMID: 18451347 DERIVED

• Yokoyama M, Origasa H, Matsuzaki M, Matsuzawa Y, Saito Y, Ishikawa Y, Oikawa S, Sasaki J, Hishida H, Itakura H, Kita T, Kitabatake A, Nakaya N, Sakata T, Shimada K, Shirato K; Japan EPA lipid intervention study (JELIS) Investigators. Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis. Lancet. 2007 Mar 31;369(9567):1090-8. doi: 10.1016/S0140-6736(07)60527-3.

  PMID: 17398308 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Angina, Unstable; Death, Sudden, Cardiac; Stroke; Peripheral Arterial Disease; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Heart Arrest; Death, Sudden; Death; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Coronary Disease

Study Officials

• Mitsuhiro Yokoyama, MD, PhD.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 3, 2005
• First Posted: October 4, 2005
• Study Start: November 1, 1996
• Study Completion: November 1, 2004
• Last Updated: November 20, 2015

Record last verified: 2005-10

Locations

JP (1)