UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of EPA's effects on coronary plaque inn patients with coronary heart diseases treated with PCI
Title of the study (Brief title)	The effects of EPA on coronary plaque
Region	Japan

Condition
Condition	coronary heart diseases
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effects of EPA on coronary plaque
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	coronary plaque volume
Key secondary outcomes	clinical events

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	standard therapy
Interventions/Control_2	EPA administration
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	40 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	patients with stable coronary heart diseases treated with PCI
Key exclusion criteria	1) prior taking EPA, 2) recent acute coronary syndrome (< 1 year), 3) renal insufficiency (serum creatinine > 2.0 mg / dL), 4) hepatic dysfunction (serum AST or ALT > 3-folds of standard value), 5) cancer, 6) autoimmune diseases, 7) impossibility in decision making 8) consideration as inadequate to participating in the study by attending physician.
Target sample size	50

Research contact person
Name of lead principal investigator	Atsushi Katoh
Organization	Kurume University Medical Center
Division name	Cardiology
Address	Kokubu-machi,Kurume, Fukuoka
TEL	0942-22-6111
Email	katou_atsushi@kurume-u.ac.jp

Public contact
Name of contact person	Atsushi Katoh
Organization	Kurume University Medical Center
Division name	Cardiology
Address	Kokubu-machi,Kurume, Fukuoka
TEL	0942-22-6111
Homepage URL
Email	katou_atsushi@kurume-u.ac.jp

Sponsor
Institute	Kurume University Medical Center
Institute
Department

Funding Source
Organization	Kurume University Medical Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 07 Month 22 Day
Anticipated trial start date	2011 Year 08 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	2017 Year 03 Month 24 Day
Last modified on	2017 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030647