UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of docosahexaenoic acid + eicosapentaenoic acid therapy in patients with successful coronary intervention (ESSENCE Study)
Title of the study (Brief title)	ESSENCE Study
Region	Japan

Condition
Condition	Hypertriglyceridaemia
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in triglyceride levels in blood.
Key secondary outcomes	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.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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.
Interventions/Control_2	The patients with hypertriglyceridaemia and successful coronary intervention are enrolled. The patients do not receive DHA/EPA for 12 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	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.
Key exclusion criteria	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
Target sample size	40

Research contact person
Name of lead principal investigator	Keijiro Saku
Organization	Fukuoka University Hospital
Division name	Department of Cardiology
Address	7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL	81-92-801-1011
Email	miuras@cis.fukuoka-u.ac.jp

Public contact
Name of contact person	Shin-ichiro Miura
Organization	Fukuoka University Hospital
Division name	Department of Cardiology
Address	7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL	81-92-801-1011
Homepage URL
Email	miuras@cis.fukuoka-u.ac.jp

Sponsor
Institute	Department of Cardiology, Fukuoka University Hospital
Institute
Department

Funding Source
Organization	Department of Cardiology, Fukuoka University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	福岡大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 25 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 06 Month 02 Day
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 24 Day
Last modified on	2019 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020606