Unique ID issued by UMIN | UMIN000018056 |
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Receipt number | R000020606 |
Scientific Title | Efficacy and safety of docosahexaenoic acid + eicosapentaenoic acid therapy in patients with successful coronary intervention (ESSENCE Study) |
Date of disclosure of the study information | 2015/06/25 |
Last modified on | 2019/02/14 17:56:48 |
Efficacy and safety of docosahexaenoic acid + eicosapentaenoic acid therapy in patients with successful coronary intervention (ESSENCE Study)
ESSENCE Study
Efficacy and safety of docosahexaenoic acid + eicosapentaenoic acid therapy in patients with successful coronary intervention (ESSENCE Study)
ESSENCE Study
Japan |
Hypertriglyceridaemia
Cardiology |
Others
NO
Although statin therapy represents a cornerstone of cardiovascular disease (CVD) prevention, a major residual CVD risk (60-70 % of total relative risk) remains. In addition, eicosapentaenoic acid (EPA) is a treatment for prevention of major coronary events, and especially non-fatal coronary events, in Japanese hypercholesterolaemic patients. It is not known whether EPA+docosahexaenoic acid (DHA) therapy is effective for preventing CVD. Therefore, we analyze the efficacy and safety of EPA+DHA therapy and compare it with non-EPA+DHA therapy in patients with hypertriglyceridaemia and successful coronary intervention.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Changes in triglyceride levels in blood.
Changes in pulse wave velocity.
Changes in biochemical parameters (high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, total cholesterol and fraction of fatty acid.
Changes in triglyceride levels in blood(breakfact after 2, 4 and 8 hrs).
Adverse effects.
Investigate MACE (MI,TLR adnd Death) for 1 year.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
The patients with hypertriglyceridaemia and successful coronary intervention are enrolled. The patients receive DHA+EPA (2g/day) and treat for 12 weeks. If the levels of triglyceride in blood is more than 150 mg/dl after 4 weeks, the patients receive DHA+PA (4g/day) until 12 weeks.
The patients with hypertriglyceridaemia and successful coronary intervention are enrolled. The patients do not receive DHA/EPA for 12 weeks.
20 | years-old | <= |
Not applicable |
Male and Female
1.Patients who had the levels of fasting triglyceride more than 150 mg/dl.
2.Age is 20 years old or more and gender is male or female.
3.Patinets with successful percutaneous coronary intervention
4.Patients who gave their written informed consent to participate for the present study.
1.Severe cardiac failure
2.Severe liver dysfunction
3.Severe renal dysfunction
4.Pregnancy or lactation in women
5.Patients with a history of allergy to any component of the study medications
6.Ineligible patients according to the judgment by physician
40
1st name | |
Middle name | |
Last name | Keijiro Saku |
Fukuoka University Hospital
Department of Cardiology
7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
81-92-801-1011
miuras@cis.fukuoka-u.ac.jp
1st name | |
Middle name | |
Last name | Shin-ichiro Miura |
Fukuoka University Hospital
Department of Cardiology
7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
81-92-801-1011
miuras@cis.fukuoka-u.ac.jp
Department of Cardiology, Fukuoka University Hospital
Department of Cardiology, Fukuoka University Hospital
Self funding
Japan
NO
福岡大学病院(福岡県)
2015 | Year | 06 | Month | 25 | Day |
Unpublished
Terminated
2015 | Year | 06 | Month | 02 | Day |
2015 | Year | 07 | Month | 01 | Day |
2015 | Year | 06 | Month | 24 | Day |
2019 | Year | 02 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020606
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