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Sponsors and Collaborators: |
Kobe University Mochida Pharmaceutical |
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Information provided by: | Kobe University |
ClinicalTrials.gov Identifier: | NCT00231738 |
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 |
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Myocardial Infarction, Unstable Angina Pectoris, Sudden Cardiac Death, Stroke, Peripheral Artery Disease |
Drug: Eicosapentaenoic acid ethyl ester(EPADEL Capsule 300 TM) |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Eicosapentaenoic Acid (EPA) on Major Cardiovascular Events in Hypercholesterolemic Patients: the Japan EPA Lipid Intervention Study (JELIS) |
Estimated Enrollment: | 18000 |
Study Start Date: | November 1996 |
Estimated Study Completion Date: | November 2004 |
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.
Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan, Hyogo-prefecture | |
Kobe University Graduate School of Medicine Cardiovascular and Respiratory Medicine Division, Department of Internal Medicine | |
Kobe, Hyogo-prefecture, Japan, 650-0017 |
Principal Investigator: | Mitsuhiro Yokoyama, MD, PhD. | None |
Study ID Numbers: | No, No |
Study First Received: | October 3, 2005 |
Last Updated: | October 3, 2005 |
ClinicalTrials.gov Identifier: | NCT00231738 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Eicosapentaenoic acid Coronary artery disease |
Death Heart Diseases Cerebral Infarction Myocardial Ischemia Stroke Vascular Diseases Angina Pectoris Heart Arrest Pain Ischemia Chest Pain |
Coronary Disease Signs and Symptoms Necrosis Death, Sudden Platelet Aggregation Inhibitors Death, Sudden, Cardiac Infarction Eicosapentaenoic acid ethyl ester Myocardial Infarction Angina, Unstable Coronary Artery Disease |
Death Heart Diseases Myocardial Ischemia Hematologic Agents Angina Pectoris Vascular Diseases Heart Arrest Pain Ischemia Pharmacologic Actions Chest Pain Signs and Symptoms |
Necrosis Pathologic Processes Therapeutic Uses Death, Sudden Platelet Aggregation Inhibitors Cardiovascular Diseases Death, Sudden, Cardiac Infarction Eicosapentaenoic acid ethyl ester Angina, Unstable Myocardial Infarction |