Know Cancer

or
forgot password

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


Phase 4
40 Years
75 Years
Not Enrolling
Both
Myocardial Infarction, Unstable Angina Pectoris, Sudden Cardiac Death, Stroke, Peripheral Artery Disease

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

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)

Principal Investigator

Mitsuhiro Yokoyama, MD, PhD.

Investigator Role:

Principal Investigator

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

No

NCT ID:

NCT00231738

Start Date:

November 1996

Completion Date:

November 2004

Related Keywords:

  • Myocardial Infarction, Unstable Angina Pectoris, Sudden Cardiac Death, Stroke, Peripheral Artery Disease
  • Eicosapentaenoic acid
  • Coronary artery disease
  • Angina Pectoris
  • Angina, Unstable
  • Infarction
  • Myocardial Infarction
  • Death, Sudden, Cardiac
  • Death
  • Peripheral Arterial Disease

Name

Location