UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of eicosepenteanoic acid on ventricular arrhythmia:a prospective,open-labeled,randomized controlled clinical trial
Title of the study (Brief title)	Treatment of ventricular arrhythmia by eicosepentanoic acid
Region	Japan

Condition
Condition	ventricular tachycardia ventricular fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness and safety of eicosapentaenoic acid for patients treated with implantable cardioverter-defibrillators (ICDs) who were at high risk of recurrent ventricular arrhythmias
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint was appropriate ICD therapy for VT/VF confirmed by stored electrograms, or death from any cause.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A:standard therapeutic drug
Interventions/Control_2	B:standard therapeutic drug + eicosapentaenoic acid 1800mg
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with ICDs would experience 1 or more VT/VF
Key exclusion criteria	1)Allergy against eicosapentaenoic acid 2)Patients with malignant neoplasm 3)Subjects whose doctor in charge do not agree to join the trial
Target sample size	200

Research contact person
Name of lead principal investigator	Tomohide Endo
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Cardiology
Address	5 Zaifu-cho, Hirosaki, Japan
TEL	0172-39-5057
Email	endot526@hirosaki-u.ac.jp

Public contact
Name of contact person	Tomohide Endo
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Cardiology
Address	5 Zaifu-cho, Hirosaki, Japan
TEL	0172-39-5057
Homepage URL
Email	endot526@hirosaki-u.ac.jp

Sponsor
Institute	Hirosaki University Graduate School of Medicine Department of Cardiology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Hirosaki University Graduate School of Medicine
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	2016 Year 06 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 01 Month 10 Day
Anticipated trial start date	2012 Year 01 Month 10 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 28 Day
Last modified on	2016 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025817